Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144339
First received: September 2, 2005
Last updated: May 15, 2014
Last verified: April 2014
Results First Received: February 21, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: tiotropium
Drug: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
09 Jan 2003 – 22 Feb 2008; 490 centers in 37 countries

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo once daily
Tiotropium Bromide Inhalation Capsules 18 mcg once daily

Participant Flow:   Overall Study
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
STARTED     3006     2986  
COMPLETED     1648     1887  
NOT COMPLETED     1358     1099  
Adverse Event                 746                 627  
Protocol Violation                 75                 48  
Withdrawal by Subject                 403                 300  
Lost to Follow-up                 76                 64  
unknown                 58                 60  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg     Total  
Number of Participants  
[units: participants]
  3006     2986     5992  
Age  
[units: years]
Mean ± Standard Deviation
  64.52  ± 8.48     64.50  ± 8.41     64.51  ± 8.45  
Gender  
[units: participants]
     
Female     784     735     1519  
Male     2222     2251     4473  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]

Measure Type Primary
Measure Title Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
Measure Description Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.
Time Frame From day 30 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2413     2557  
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years  
[units: ml/year]
Mean ± Standard Error
  -30  ± 1     -30  ± 1  


Statistical Analysis 1 for Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.9524
Mean Difference (Final Values) [4] 0
Standard Error of the mean ± 2
95% Confidence Interval ( -4 to 4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linear random effects model
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Random-effects model
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model



2.  Primary:   Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]

Measure Type Primary
Measure Title Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
Measure Description Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.
Time Frame From day 30 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2410     2554  
Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years  
[units: ml/year]
Mean ± Standard Error
  -42  ± 1     -40  ± 1  


Statistical Analysis 1 for Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.2074
Mean Difference (Final Values) [4] 2
Standard Error of the mean ± 2
95% Confidence Interval ( -2 to 6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linear random effects model
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Random-effects model
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model



3.  Secondary:   Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. ]

Measure Type Secondary
Measure Title Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Measure Description Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1
Time Frame Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  1618     1803  
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment  
[units: ml/year]
Median ± Standard Error
  -17  ± 2     -15  ± 2  


Statistical Analysis 1 for Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Groups [1] All groups
Method [2] Wilcoxon Rank-sum test
P Value [3] 0.2488
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



4.  Secondary:   Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]

Measure Type Secondary
Measure Title Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Measure Description Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1
Time Frame Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  1613     1805  
Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment  
[units: ml/year]
Median ± Standard Error
  -32  ± 2     -27  ± 2  


Statistical Analysis 1 for Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Groups [1] All groups
Method [2] Wilcoxon Rank-sum test
P Value [3] 0.0145
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Secondary:   Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]

Measure Type Secondary
Measure Title Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
Measure Description Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Time Frame From day 30 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2413     2557  
Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years  
[units: ml/year]
Mean ± Standard Error
  -39  ± 3     -43  ± 3  


Statistical Analysis 1 for Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.2990
Mean Difference (Final Values) [4] -4
Standard Error of the mean ± 4
95% Confidence Interval ( -12 to 4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linear random effects model
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model



6.  Secondary:   Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]

Measure Type Secondary
Measure Title Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
Measure Description Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Time Frame From day 30 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2410     2554  
Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years  
[units: ml/year]
Mean ± Standard Error
  -61  ± 3     -61  ± 3  


Statistical Analysis 1 for Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.8375
Mean Difference (Final Values) [4] -1
Standard Error of the mean ± 4
95% Confidence Interval ( -9 to 7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linear random effects model
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model



7.  Secondary:   Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]

Measure Type Secondary
Measure Title Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
Measure Description Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Time Frame From day 30 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2531  
Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years  
[units: ml/year]
Mean ± Standard Error
  -41  ± 3     -47  ± 3  


Statistical Analysis 1 for Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.1143
Median Difference (Final Values) [4] -6
Standard Error of the mean ± 4
95% Confidence Interval ( -14 to 2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linear random effects model
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model



8.  Secondary:   Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]

Measure Type Secondary
Measure Title Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
Measure Description Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Time Frame From day 30 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2383     2527  
Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years  
[units: ml/year]
Mean ± Standard Error
  -65  ± 3     -66  ± 3  


Statistical Analysis 1 for Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.7870
Median Difference (Final Values) [4] -1
Standard Error of the mean ± 4
95% Confidence Interval ( -9 to 7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linear random effects model
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model



9.  Secondary:   Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score   [ Time Frame: From month 6 to 4 years ]

Measure Type Secondary
Measure Title Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score
Measure Description SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).
Time Frame From month 6 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2362     2505  
Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score  
[units: Score on scale per year]
Mean ± Standard Error
  1.21  ± 0.09     1.25  ± 0.09  


Statistical Analysis 1 for Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.7840
Mean Difference (Final Values) [4] 0.04
Standard Error of the mean ± 0.13
95% Confidence Interval ( -0.2 to 0.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linear random effects model
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model



10.  Secondary:   Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. ]

Measure Type Secondary
Measure Title Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Measure Description Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Time Frame Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  1618     1803  
Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment  
[units: ml/year]
Median ± Standard Error
  -12  ± 4     -10  ± 3  


Statistical Analysis 1 for Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Groups [1] All groups
Method [2] Wilcoxon Rank-sum test
P Value [3] 0.2705
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



11.  Secondary:   Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]

Measure Type Secondary
Measure Title Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Measure Description Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Time Frame Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  1613     1805  
Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment  
[units: ml/year]
Median ± Standard Error
  -40  ± 4     -40  ± 3  


Statistical Analysis 1 for Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Groups [1] All groups
Method [2] Wilcoxon Rank-sum test
P Value [3] 0.306
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



12.  Secondary:   Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]

Measure Type Secondary
Measure Title Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Measure Description Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Time Frame Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  1562     1706  
Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment  
[units: ml/year]
Median ± Standard Error
  -17  ± 4     -17  ± 4  


Statistical Analysis 1 for Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Groups [1] All groups
Method [2] Wilcoxon Rank-sum test
P Value [3] 0.8103
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



13.  Secondary:   Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]

Measure Type Secondary
Measure Title Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Measure Description Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Time Frame Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  1540     1711  
Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment  
[units: ml/year]
Median ± Standard Error
  -46  ± 4     -42  ± 3  


Statistical Analysis 1 for Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Groups [1] All groups
Method [2] Wilcoxon Rank-sum test
P Value [3] 0.9814
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



14.  Secondary:   Time to First Exacerbation   [ Time Frame: From Day 1 to 4 years ]

Measure Type Secondary
Measure Title Time to First Exacerbation
Measure Description Chronic obstructive pulmonary disease (COPD) exacerbation
Time Frame From Day 1 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  3006     2986  
Time to First Exacerbation  
[units: months]
Median ( 95% Confidence Interval )
  12.51  
  ( 11.53 to 13.79 )  
  16.65  
  ( 14.88 to 17.87 )  


Statistical Analysis 1 for Time to First Exacerbation
Groups [1] All groups
Method [2] Log Rank
P Value [3] <0.0001
Hazard Ratio (HR) [4] 0.86
Standard Error of the mean ± 0.03
95% Confidence Interval ( 0.81 to 0.91 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Cox regression
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Cox regression with treatment
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Median estimated by Kaplan-Meier estimates; hazard ratio shown as tio vs. placebo



15.  Secondary:   Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year   [ Time Frame: Day 1 to 4 years ]

Measure Type Secondary
Measure Title Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year
Measure Description No text entered.
Time Frame Day 1 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  3006     2986  
Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year  
[units: number per patient year]
Mean ± Standard Error
  0.85  ± 0.02     0.73  ± 0.02  


Statistical Analysis 1 for Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] <0.0001
Rate Ratio [4] 0.86
Standard Error of the mean ± 0.03
95% Confidence Interval ( 0.81 to 0.91 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Poisson regression adjusted for overdispersion and treatment exposure
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Ratio calculated as estimated number of events in tio/number of events in placebo



16.  Secondary:   Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation   [ Time Frame: Day 1 to 4 years ]

Measure Type Secondary
Measure Title Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Measure Description No text entered.
Time Frame Day 1 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  3006     2986  
Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation  
[units: Participants]
   
Number of patients     2049     2001  
Percentage of patients     68.2     67  


Statistical Analysis 1 for Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.3481
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



17.  Secondary:   Number of Exacerbation Days Per Patient Year   [ Time Frame: Day 1 to 4 years ]

Measure Type Secondary
Measure Title Number of Exacerbation Days Per Patient Year
Measure Description Number of exacerbation days normalized by treatment exposure
Time Frame Day 1 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  3006     2986  
Number of Exacerbation Days Per Patient Year  
[units: days/patient year]
Mean ± Standard Error
  13.64  ± 0.35     12.11  ± 0.32  


Statistical Analysis 1 for Number of Exacerbation Days Per Patient Year
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.0011
Rate Ratio [4] 0.89
Standard Error of the mean ± 0.03
95% Confidence Interval ( 0.83 to 0.95 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Poisson regression adjusted for overdispersion and treatment exposure
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Poisson regression adjusting for overdispersion with Pearson’s method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.



18.  Secondary:   Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)   [ Time Frame: Day 1 to 4 years ]

Measure Type Secondary
Measure Title Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)
Measure Description No text entered.
Time Frame Day 1 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  3006     2986  
Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)  
[units: months]
Median ( 95% Confidence Interval )
  28.64  
  ( 26.08 to 31.82 )  
  35.89  
  ( 23.38 to 39.54 )  


Statistical Analysis 1 for Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.1766
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



19.  Secondary:   Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization   [ Time Frame: From Day 1 to 4 years ]

Measure Type Secondary
Measure Title Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization
Measure Description No text entered.
Time Frame From Day 1 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  3006     2986  
Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization  
[units: Participants]
   
Number of patients     811     759  
Percentage of patients     27     25.4  


Statistical Analysis 1 for Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.0024
Hazard Ratio (HR) [4] 0.86
Standard Error of the mean ± 0.04
95% Confidence Interval ( 0.78 to 0.95 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Cox regression
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Hazard ratio shown as tiotropium bromide vs. placebo



20.  Secondary:   Number of Exacerbation Leading to Hospitalization   [ Time Frame: From Day 1 to 4 years ]

Measure Type Secondary
Measure Title Number of Exacerbation Leading to Hospitalization
Measure Description Estimated number of exacerbations leading to hospitalizations per patient year
Time Frame From Day 1 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  3006     2986  
Number of Exacerbation Leading to Hospitalization  
[units: Number per patient year]
  0.16     0.15  


Statistical Analysis 1 for Number of Exacerbation Leading to Hospitalization
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.3413
Rate ratio [4] 0.94
Standard Error of the mean ± 0.06
95% Confidence Interval ( 0.82 to 1.07 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Ratio of estimated number of events between tiotropium bromide and placebo



21.  Secondary:   Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization   [ Time Frame: From Day 1 to 4 years ]

Measure Type Secondary
Measure Title Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization
Measure Description Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)
Time Frame From Day 1 to 4 years  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  3006     2986  
Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization  
[units: days/patient year]
Mean ± Standard Error
  3.13  ± 0.17     3.17  ± 0.17  


Statistical Analysis 1 for Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.8624
Rate ratio [4] 1.01
95% Confidence Interval ( 0.87 to 1.18 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Poisson regression adjusting for overdispersion with Pearson’s method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Ratio of estimated number of days of chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization between tio and placebo



22.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1   [ Time Frame: Month 1 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
Measure Description Estimated FEV1 before bronchodilator at Month 1
Time Frame Month 1  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1  
[units: L]
Mean ± Standard Error
  1.134  ± 0.004     1.221  ± 0.004  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.087
95% Confidence Interval ( 0.077 to 0.098 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



23.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1   [ Time Frame: Month 1 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
Measure Description Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1
Time Frame Month 1  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1  
[units: L]
Mean ± Standard Error
  1.372  ± 0.004     1.418  ± 0.004  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.047
95% Confidence Interval ( 0.037 to 0.057 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



24.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
Measure Description Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6
Time Frame Month 6  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6  
[units: L]
Mean ± Standard Error
  1.126  ± 0.004     1.225  ± 0.004  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.099
95% Confidence Interval ( 0.087 to 0.110 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



25.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
Measure Description No text entered.
Time Frame Month 6  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6  
[units: L]
Mean ± Standard Deviation
  1.365  ± 0.004     1.423  ± 0.004  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.058
95% Confidence Interval ( 0.047 to 0.069 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



26.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Measure Description No text entered.
Time Frame Month 12  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12  
[units: L]
Mean ± Standard Error
  1.111  ± 0.004     1.213  ± 0.004  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.103
95% Confidence Interval ( 0.091 to 0.115 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



27.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Measure Description No text entered.
Time Frame Month 12  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12  
[units: L]
Mean ± Standard Error
  1.345  ± 0.004     1.398  ± 0.004  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Median Difference (Final Values) [4] 0.054
95% Confidence Interval ( 0.042 to 0.065 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



28.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18   [ Time Frame: Month 18 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Measure Description No text entered.
Time Frame Month 18  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18  
[units: L]
Mean ± Standard Error
  1.101  ± 0.005     1.192  ± 0.005  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.091
95% Confidence Interval ( 0.078 to 0.104 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



29.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18   [ Time Frame: Month 18 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Measure Description No text entered.
Time Frame Month 18  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18  
[units: L]
Mean ± Standard Error
  1.326  ± 0.005     1.379  ± 0.005  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.053
95% Confidence Interval ( 0.040 to 0.066 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



30.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24   [ Time Frame: Month 24 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Measure Description No text entered.
Time Frame Month 24  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24  
[units: L]
Mean ± Standard Error
  1.079  ± 0.005     1.173  ± 0.005  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.094
95% Confidence Interval ( 0.081 to 0.107 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



31.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24   [ Time Frame: Month 24 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Measure Description No text entered.
Time Frame Month 24  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24  
[units: L]
Mean ± Standard Error
  1.294  ± 0.005     1.356  ± 0.005  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.062
95% Confidence Interval ( 0.049 to 0.075 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



32.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30   [ Time Frame: Month 30 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Measure Description No text entered.
Time Frame Month 30  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30  
[units: L]
Mean ± Standard Error
  1.061  ± 0.005     1.156  ± 0.005  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.095
95% Confidence Interval ( 0.081 to 0.109 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



33.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30   [ Time Frame: Month 30 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Measure Description No text entered.
Time Frame Month 30  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30  
[units: L]
Mean ± Standard Error
  1.274  ± 0.005     1.335  ± 0.005  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.061
95% Confidence Interval ( 0.047 to 0.075 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



34.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36   [ Time Frame: Month 36 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Measure Description No text entered.
Time Frame Month 36  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36  
[units: L]
Mean ± Standard Error
  1.045  ± 0.005     1.144  ± 0.005  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.099
95% Confidence Interval ( 0.085 to 0.114 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



35.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36   [ Time Frame: Month 36 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Measure Description No text entered.
Time Frame Month 36  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36  
[units: L]
Mean ± Standard Error
  1.250  ± 0.005     1.315  ± 0.005  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.065
95% Confidence Interval ( 0.051 to 0.080 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



36.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42   [ Time Frame: Month 42 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
Measure Description No text entered.
Time Frame Month 42  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42  
[units: L]
Mean ± Standard Error
  1.034  ± 0.005     1.129  ± 0.005  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.095
95% Confidence Interval ( 0.080 to 0.110 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



37.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42   [ Time Frame: Month 42 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
Measure Description Estimated FEV1 after bronchodilator at Month 42
Time Frame Month 42  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42  
[units: L]
Mean ± Standard Error
  1.236  ± 0.006     1.297  ± 0.005  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.061
95% Confidence Interval ( 0.045 to 0.076 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



38.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48   [ Time Frame: Month 48 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Measure Description No text entered.
Time Frame Month 48  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48  
[units: L]
Mean ± Standard Error
  1.024  ± 0.006     1.112  ± 0.005  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.088
95% Confidence Interval ( 0.073 to 0.103 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



39.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48   [ Time Frame: Month 48 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Measure Description No text entered.
Time Frame Month 48  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48  
[units: L]
Mean ± Standard Error
  1.219  ± 0.006     1.268  ± 0.006  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.049
95% Confidence Interval ( 0.033 to 0.065 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



40.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1   [ Time Frame: Month 1 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1
Measure Description No text entered.
Time Frame Month 1  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1  
[units: L]
Mean ± Standard Error
  2.667  ± 0.008     2.856  ± 0.008  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.190
95% Confidence Interval ( 0.168 to 0.211 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



41.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1   [ Time Frame: Month 1 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1
Measure Description No text entered.
Time Frame Month 1  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1  
[units: L]
Mean ± Standard Error
  3.149  ± 0.007     3.204  ± 0.006  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.055
95% Confidence Interval ( 0.037 to 0.073 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



42.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6
Measure Description No text entered.
Time Frame Month 6  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6  
[units: L]
Mean ± Standard Error
  2.658  ± 0.009     2.862  ± 0.008  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.204
95% Confidence Interval ( 0.180 to 0.228 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



43.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6
Measure Description No text entered.
Time Frame Month 6  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6  
[units: L]
Mean ± Standard Error
  3.137  ± 0.008     3.193  ± 0.007  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.055
95% Confidence Interval ( 0.034 to 0.076 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



44.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12
Measure Description No text entered.
Time Frame Month 12  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12  
[units: L]
Mean ± Standard Error
  2.640  ± 0.009     2.838  ± 0.009  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.198
95% Confidence Interval ( 0.173 to 0.222 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



45.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12
Measure Description No text entered.
Time Frame Month 12  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12  
[units: L]
Mean ± Standard Error
  3.110  ± 0.008     3.158  ± 0.008  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.048
95% Confidence Interval ( 0.026 to 0.070 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



46.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18   [ Time Frame: Month 18 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18
Measure Description No text entered.
Time Frame Month 18  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18  
[units: L]
Mean ± Standard Error
  2.622  ± 0.010     2.816  ± 0.010  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.194
95% Confidence Interval ( 0.167 to 0.221 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



47.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18   [ Time Frame: Month 18 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18
Measure Description No text entered.
Time Frame Month 18  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18  
[units: L]
Mean ± Standard Error
  3.075  ± 0.009     3.126  ± 0.009  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.050
95% Confidence Interval ( 0.026 to 0.074 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



48.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24   [ Time Frame: Month 24 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24
Measure Description No text entered.
Time Frame Month 24  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24  
[units: L]
Mean ± Standard Error
  2.597  ± 0.010     2.785  ± 0.010  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.189
95% Confidence Interval ( 0.161 to 0.216 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



49.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24   [ Time Frame: Month 24 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24
Measure Description No text entered.
Time Frame Month 24  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24  
[units: L]
Mean ± Standard Error
  3.036  ± 0.009     3.095  ± 0.009  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.059
95% Confidence Interval ( 0.035 to 0.084 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



50.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30   [ Time Frame: Month 30 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30
Measure Description No text entered.
Time Frame Month 30  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30  
[units: L]
Mean ± Standard Error
  2.572  ± 0.010     2.757  ± 0.010  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.185
95% Confidence Interval ( 0.157 to 0.213 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



51.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30   [ Time Frame: Month 30 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30
Measure Description No text entered.
Time Frame Month 30  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30  
[units: L]
Mean ± Standard Error
  3.010  ± 0.010     3.057  ± 0.009  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0005
Mean Difference (Final Values) [4] 0.047
95% Confidence Interval ( 0.021 to 0.074 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



52.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36   [ Time Frame: Month 36 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36
Measure Description No text entered.
Time Frame Month 36  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36  
[units: L]
Mean ± Standard Error
  2.553  ± 0.011     2.753  ± 0.010  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.200
95% Confidence Interval ( 0.170 to 0.229 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



53.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36   [ Time Frame: Month 36 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36
Measure Description No text entered.
Time Frame Month 36  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36  
[units: L]
Mean ± Standard Error
  2.973  ± 0.010     3.038  ± 0.010  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.065
95% Confidence Interval ( 0.038 to 0.093 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



54.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42   [ Time Frame: Month 42 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42
Measure Description No text entered.
Time Frame Month 42  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42  
[units: L]
Mean ± Standard Error
  2.540  ± 0.011     2.724  ± 0.011  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.184
95% Confidence Interval ( 0.154 to 0.215 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



55.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42   [ Time Frame: Month 42 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42
Measure Description No text entered.
Time Frame Month 42  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42  
[units: L]
Mean ± Standard Error
  2.959  ± 0.011     3.005  ± 0.010  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0020
Mean Difference (Final Values) [4] 0.046
95% Confidence Interval ( 0.017 to 0.076 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



56.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48   [ Time Frame: Month 48 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48
Measure Description No text entered.
Time Frame Month 48  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2363     2494  
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48  
[units: L]
Mean ± Standard Error
  2.532  ± 0.011     2.702  ± 0.011  


Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.170
95% Confidence Interval ( 0.139 to 0.201 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



57.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48   [ Time Frame: Month 48 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48
Measure Description No text entered.
Time Frame Month 48  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2374     2516  
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48  
[units: L]
Mean ± Standard Error
  2.929  ± 0.011     2.961  ± 0.010  


Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0365
Mean Difference (Final Values) [4] 0.032
95% Confidence Interval ( 0.002 to 0.061 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



58.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1   [ Time Frame: Month 1 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1
Measure Description No text entered.
Time Frame Month 1  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2325     2447  
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1  
[units: L]
Mean ± Standard Error
  2.847  ± 0.008     3.017  ± 0.008  


Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.170
95% Confidence Interval ( 0.147 to 0.192 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



59.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1   [ Time Frame: Month 1 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1
Measure Description No text entered.
Time Frame Month 1  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2340     2467  
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1  
[units: L]
Mean ± Standard Error
  3.280  ± 0.007     3.318  ± 0.007  


Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0002
Mean Difference (Final Values) [4] 0.038
95% Confidence Interval ( 0.018 to 0.058 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



60.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6
Measure Description No text entered.
Time Frame Month 6  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2325     2447  
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6  
[units: L]
Mean ± Standard Error
  2.841  ± 0.009     3.027  ± 0.009  


Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.186
95% Confidence Interval ( 0.161 to 0.210 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



61.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6
Measure Description No text entered.
Time Frame Month 6  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2340     2467  
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6  
[units: L]
Mean ± Standard Error
  3.268  ± 0.008     3.304  ± 0.008  


Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0018
Mean Difference (Final Values) [4] 0.037
95% Confidence Interval ( 0.014 to 0.060 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



62.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12
Measure Description No text entered.
Time Frame Month 12  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2325     2447  
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12  
[units: L]
Mean ± Standard Error
  2.820  ± 0.009     2.996  ± 0.009  


Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.176
95% Confidence Interval ( 0.151 to 0.201 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



63.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12
Measure Description No text entered.
Time Frame Month 12  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2340     2467  
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12  
[units: L]
Mean ± Standard Error
  3.228  ± 0.008     3.260  ± 0.008  


Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0069
Mean Difference (Final Values) [4] 0.032
95% Confidence Interval ( 0.009 to 0.055 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



64.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18   [ Time Frame: Month 18 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18
Measure Description No text entered.
Time Frame Month 18  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2325     2447  
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18  
[units: L]
Mean ± Standard Error
  2.811  ± 0.010     2.965  ± 0.010  


Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.154
95% Confidence Interval ( 0.127 to 0.182 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



65.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18   [ Time Frame: Month 18 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18
Measure Description No text entered.
Time Frame Month 18  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2340     2467  
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18  
[units: L]
Mean ± Standard Error
  3.195  ± 0.009     3.234  ± 0.009  


Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0020
Mean Difference (Final Values) [4] 0.040
95% Confidence Interval ( 0.015 to 0.065 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



66.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24   [ Time Frame: Month 24 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24
Measure Description No text entered.
Time Frame Month 24  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2325     2447  
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24  
[units: L]
Mean ± Standard Error
  2.775  ± 0.010     2.942  ± 0.010  


Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.167
95% Confidence Interval ( 0.139 to 0.194 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



67.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24   [ Time Frame: Month 24 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24
Measure Description No text entered.
Time Frame Month 24  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2340     2467  
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24  
[units: L]
Mean ± Standard Error
  3.157  ± 0.009     3.189  ± 0.009  


Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0165
Mean Difference (Final Values) [4] 0.032
95% Confidence Interval ( 0.006 to 0.057 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



68.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30   [ Time Frame: Month 30 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30
Measure Description No text entered.
Time Frame Month 30  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2325     2447  
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30  
[units: L]
Mean ± Standard Error
  2.738  ± 0.011     2.908  ± 0.010  


Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.170
95% Confidence Interval ( 0.141 to 0.199 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



69.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30   [ Time Frame: Month 30 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30
Measure Description No text entered.
Time Frame Month 30  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2340     2467  
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30  
[units: L]
Mean ± Standard Error
  3.126  ± 0.010     3.157  ± 0.010  


Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0248
Mean Difference (Final Values) [4] 0.031
95% Confidence Interval ( 0.004 to 0.059 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



70.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36   [ Time Frame: Month 36 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36
Measure Description No text entered.
Time Frame Month 36  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2325     2447  
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36  
[units: L]
Mean ± Standard Error
  2.731  ± 0.011     2.897  ± 0.010  


Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.166
95% Confidence Interval ( 0.136 to 0.196 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



71.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36   [ Time Frame: Month 36 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36
Measure Description No text entered.
Time Frame Month 36  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2340     2467  
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36  
[units: L]
Mean ± Standard Error
  3.086  ± 0.010     3.136  ± 0.010  


Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0004
Mean Difference (Final Values) [4] 0.050
95% Confidence Interval ( 0.022 to 0.078 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



72.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42   [ Time Frame: Month 42 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42
Measure Description No text entered.
Time Frame Month 42  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2325     2447  
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42  
[units: L]
Mean ± Standard Error
  2.713  ± 0.011     2.875  ± 0.011  


Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.161
95% Confidence Interval ( 0.130 to 0.192 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



73.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42   [ Time Frame: Month 42 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42
Measure Description No text entered.
Time Frame Month 42  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2340     2467  
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42  
[units: L]
Mean ± Standard Error
  3.073  ± 0.011     3.100  ± 0.011  


Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0809
Mean Difference (Final Values) [4] 0.027
95% Confidence Interval ( -0.003 to 0.057 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



74.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48   [ Time Frame: Month 48 ]

Measure Type Secondary
Measure Title Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48
Measure Description No text entered.
Time Frame Month 48  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2325     2447  
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48  
[units: L]
Mean ± Standard Error
  2.696  ± 0.012     2.846  ± 0.011  


Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] 0.150
95% Confidence Interval ( 0.119 to 0.182 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



75.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48   [ Time Frame: Month 48 ]

Measure Type Secondary
Measure Title Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48
Measure Description No text entered.
Time Frame Month 48  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2340     2467  
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48  
[units: L]
Mean ± Standard Error
  3.041  ± 0.011     3.067  ± 0.011  


Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0915
Mean Difference (Final Values) [4] 0.026
95% Confidence Interval ( -0.004 to 0.057 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



76.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6
Measure Description
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Time Frame Month 6  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2337     2478  
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6  
[units: Units on a scale]
Mean ± Standard Error
  42.289  ± 0.240     39.409  ± 0.233  


Statistical Analysis 1 for Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] -2.880
95% Confidence Interval ( -3.535 to -2.226 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



77.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12
Measure Description
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Time Frame Month 12  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2337     2478  
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12  
[units: Units on a scale]
Mean ± Standard Error
  42.501  ± 0.253     39.730  ± 0.245  


Statistical Analysis 1 for Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] -2.771
95% Confidence Interval ( -3.461 to -2.081 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



78.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18   [ Time Frame: Month 18 ]

Measure Type Secondary
Measure Title Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18
Measure Description
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Time Frame Month 18  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2337     2478  
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18  
[units: Units on a scale]
Mean ± Standard Error
  43.067  ± 0.278     40.474  ± 0.269  


Statistical Analysis 1 for Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] -2.593
95% Confidence Interval ( -3.352 to -1.834 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



79.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24   [ Time Frame: Month 24 ]

Measure Type Secondary
Measure Title Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24
Measure Description
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Time Frame Month 24  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2337     2478  
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24  
[units: Units on a scale]
Mean ± Standard Error
  43.562  ± 0.297     41.178  ± 0.286  


Statistical Analysis 1 for Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] -2.384
95% Confidence Interval ( -3.191 to -1.576 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



80.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30   [ Time Frame: Month 30 ]

Measure Type Secondary
Measure Title Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30
Measure Description
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Time Frame Month 30  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2337     2478  
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30  
[units: Units on a scale]
Mean ± Standard Error
  44.342  ± 0.315     41.919  ± 0.301  


Statistical Analysis 1 for Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] -2.423
95% Confidence Interval ( -3.277 to -1.569 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



81.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36   [ Time Frame: Month 36 ]

Measure Type Secondary
Measure Title Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36
Measure Description
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Time Frame Month 36  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2337     2478  
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36  
[units: Units on a scale]
Mean ± Standard Error
  45.280  ± 0.326     41.935  ± 0.311  


Statistical Analysis 1 for Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] -3.345
95% Confidence Interval ( -4.229 to -2.462 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



82.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42   [ Time Frame: Month 42 ]

Measure Type Secondary
Measure Title Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42
Measure Description
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Time Frame Month 42  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2337     2478  
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42  
[units: Units on a scale]
Mean ± Standard Error
  45.722  ± 0.342     42.905  ± 0.325  


Statistical Analysis 1 for Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] -2.818
95% Confidence Interval ( -3.742 to -1.894 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



83.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48   [ Time Frame: Month 48 ]

Measure Type Secondary
Measure Title Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48
Measure Description
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
Time Frame Month 48  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  2337     2478  
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48  
[units: Units on a scale]
Mean ± Standard Error
  45.968  ± 0.357     43.665  ± 0.338  


Statistical Analysis 1 for Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48
Groups [1] All groups
Method [2] ANOVA
P Value [3] <.0001
Mean Difference (Final Values) [4] -2.303
95% Confidence Interval ( -3.266 to -1.340 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measures ANOVA
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



84.  Secondary:   Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days ]

Measure Type Secondary
Measure Title Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)
Measure Description On-treatment defined as day 1 to completion of double blinded treatment plus 30 days
Time Frame Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  3006     2986  
Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)  
[units: Participants]
   
Number of patients with on-treatment death     402     374  
Percentage patients with on-treatment death     13.4     12.5  


Statistical Analysis 1 for Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.0242
Hazard Ratio (HR) [4] 0.85
Standard Error of the mean ± 0.06
95% Confidence Interval ( 0.74 to 0.98 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo



85.  Secondary:   Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)   [ Time Frame: Day 1 to day 1470 ]

Measure Type Secondary
Measure Title Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)
Measure Description All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.
Time Frame Day 1 to day 1470  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  3006     2986  
Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)  
[units: Participants]
   
Number of patients died from day 1 to day 1470     495     446  
Percentage of patients died from day 1 to day 1470     16.5     14.9  


Statistical Analysis 1 for Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.0859
Hazard Ratio (HR) [4] 0.89
Standard Error of the mean ± 0.06
95% Confidence Interval ( 0.79 to 1.02 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tio vs. placebo



86.  Secondary:   Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days ]

Measure Type Secondary
Measure Title Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)
Measure Description The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days
Time Frame Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  3006     2986  
Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)  
[units: Participants]
   
Number of patients with lower respiratory     140     131  
Percentage of patients with lower respiratory     4.7     4.4  


Statistical Analysis 1 for Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.1936
Hazard Ratio (HR) [4] 0.85
95% Confidence Interval ( 0.67 to 1.08 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo



87.  Secondary:   Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)   [ Time Frame: Day 1 to day 1470 ]

Measure Type Secondary
Measure Title Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)
Measure Description The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used
Time Frame Day 1 to day 1470  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  3006     2986  
Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)  
[units: Participants]
   
Number of patients with lower respiratory death     173     153  
Percentage patients with lower respiratory death     5.8     5.1  


Statistical Analysis 1 for Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.2377
Hazard Ratio (HR) [4] 0.88
95% Confidence Interval ( 0.71 to 1.09 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tiotropium bromide vs. placebo



88.  Post-Hoc:   Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1440 Days)   [ Time Frame: Day 1 to day 1440 ]

Measure Type Post-Hoc
Measure Title Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1440 Days)
Measure Description No text entered.
Time Frame Day 1 to day 1440  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
    Placebo     Tiotropium Bromide Inhalation Capsules 18 mcg  
Number of Participants Analyzed  
[units: participants]
  3006     2986  
Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1440 Days)  
[units: Participants]
   
Number of patients died from day 1 to day 1440     491     430  
Percentage of patients died from day 1 to day 1440     16.3     14.4  


Statistical Analysis 1 for Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1440 Days)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.0339