Evaluation of the Long Term Effects of Spiriva on Lung Function in COPD Patients
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ClinicalTrials.gov Identifier: NCT00144339 
Recruitment Status
:
Completed
First Posted
: September 5, 2005
Results First Posted
: August 17, 2009
Last Update Posted
: May 20, 2014

Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
 Study Details
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Study Type:  Interventional 

Study Design:  Intervention Model: Parallel Assignment; Primary Purpose: Treatment 
Condition: 
Pulmonary Disease, Chronic Obstructive 
Interventions: 
Drug: tiotropium Drug: placebo 
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 
PreAssignment 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 Followup  76  64 
Other  58  60 
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  

Overall Participants Analyzed [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
1. Primary:  Prebronchodilator 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  Prebronchodilator 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 
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  

Participants Analyzed [Units: Participants] 
2413  2557 
Prebronchodilator 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 Prebronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ttest, 2 sided 
P Value ^{[4]}  0.9524 
Mean Difference (Final Values) ^{[5]}  0 
95% Confidence Interval  4 to 4 
Standard Error of the mean  (2) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Linear random effects model  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Randomeffects model  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  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:  Postbronchodilator 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  Postbronchodilator 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 
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  

Participants Analyzed [Units: Participants] 
2410  2554 
Postbronchodilator 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 Postbronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ttest, 2 sided 
P Value ^{[4]}  0.2074 
Mean Difference (Final Values) ^{[5]}  2 
95% Confidence Interval  2 to 6 
Standard Error of the mean  (2) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Linear random effects model  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Randomeffects model  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  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:  Prebronchodilator 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  Prebronchodilator 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. 
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  

Participants Analyzed [Units: Participants] 
1618  1803 
Prebronchodilator 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 Prebronchodilator 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 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Wilcoxon Ranksum test 
P Value ^{[4]}  0.2488 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  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  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered. 
4. Secondary:  Postbronchodilator 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  Postbronchodilator 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 
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  

Participants Analyzed [Units: Participants] 
1613  1805 
Postbronchodilator 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 Postbronchodilator 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 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Wilcoxon Ranksum test 
P Value ^{[4]}  0.0145 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  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  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered. 
5. Secondary:  Prebronchodilator 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  Prebronchodilator 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 
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  

Participants Analyzed [Units: Participants] 
2413  2557 
Prebronchodilator 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 Prebronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ttest, 2 sided 
P Value ^{[4]}  0.2990 
Mean Difference (Final Values) ^{[5]}  4 
95% Confidence Interval  12 to 4 
Standard Error of the mean  (4) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Linear random effects model  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  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:  Postbronchodilator 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  Postbronchodilator 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 
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  

Participants Analyzed [Units: Participants] 
2410  2554 
Postbronchodilator 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 Postbronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ttest, 2 sided 
P Value ^{[4]}  0.8375 
Mean Difference (Final Values) ^{[5]}  1 
95% Confidence Interval  9 to 7 
Standard Error of the mean  (4) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Linear random effects model  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  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:  Prebronchodilator 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  Prebronchodilator 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 
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  

Participants Analyzed [Units: Participants] 
2374  2531 
Prebronchodilator 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 Prebronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ttest, 2 sided 
P Value ^{[4]}  0.1143 
Median Difference (Final Values) ^{[5]}  6 
95% Confidence Interval  14 to 2 
Standard Error of the mean  (4) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Linear random effects model  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  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:  Postbronchodilator 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  Postbronchodilator 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 
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  

Participants Analyzed [Units: Participants] 
2383  2527 
Postbronchodilator 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 Postbronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ttest, 2 sided 
P Value ^{[4]}  0.7870 
Median Difference (Final Values) ^{[5]}  1 
95% Confidence Interval  9 to 7 
Standard Error of the mean  (4) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Linear random effects model  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  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 
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  

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 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ttest, 2 sided 
P Value ^{[4]}  0.7840 
Mean Difference (Final Values) ^{[5]}  0.04 
95% Confidence Interval  0.2 to 0.3 
Standard Error of the mean  (0.13) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Linear random effects model  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  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:  Prebronchodilator 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  Prebronchodilator 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. 
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  

Participants Analyzed [Units: Participants] 
1618  1803 
Prebronchodilator 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 Prebronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Wilcoxon Ranksum test 
P Value ^{[4]}  0.2705 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  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  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered. 
11. Secondary:  Postbronchodilator 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  Postbronchodilator 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 
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  

Participants Analyzed [Units: Participants] 
1613  1805 
Postbronchodilator 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 Postbronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Wilcoxon Ranksum test 
P Value ^{[4]}  0.306 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  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  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered. 
12. Secondary:  Prebronchodilator 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  Prebronchodilator 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 
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  

Participants Analyzed [Units: Participants] 
1562  1706 
Prebronchodilator 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 Prebronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Wilcoxon Ranksum test 
P Value ^{[4]}  0.8103 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  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  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered. 
13. Secondary:  Postbronchodilator 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  Postbronchodilator 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 
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  

Participants Analyzed [Units: Participants] 
1540  1711 
Postbronchodilator 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 Postbronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Wilcoxon Ranksum test 
P Value ^{[4]}  0.9814 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  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  
[4]  Additional information, such as whether or not the pvalue 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 
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  

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 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Log Rank 
P Value ^{[4]}  <0.0001 
Hazard Ratio (HR) ^{[5]}  0.86 
95% Confidence Interval  0.81 to 0.91 
Standard Error of the mean  (0.03) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Cox regression  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Cox regression with treatment  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
Median estimated by KaplanMeier 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 
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  

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 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ttest, 2 sided 
P Value ^{[4]}  <0.0001 
Rate Ratio ^{[5]}  0.86 
95% Confidence Interval  0.81 to 0.91 
Standard Error of the mean  (0.03) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Poisson regression adjusted for overdispersion and treatment exposure  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  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 
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  

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 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Fisher Exact 
P Value ^{[4]}  0.3481 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue 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 
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  

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 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ttest, 2 sided 
P Value ^{[4]}  0.0011 
Rate Ratio ^{[5]}  0.89 
95% Confidence Interval  0.83 to 0.95 
Standard Error of the mean  (0.03) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Poisson regression adjusted for overdispersion and treatment exposure  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  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 
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  

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 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Fisher Exact 
P Value ^{[4]}  0.1766 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue 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 
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  

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 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Log Rank 
P Value ^{[4]}  0.0024 
Hazard Ratio (HR) ^{[5]}  0.86 
95% Confidence Interval  0.78 to 0.95 
Standard Error of the mean  (0.04) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Cox regression  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  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 
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  

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 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ttest, 2 sided 
P Value ^{[4]}  0.3413 
Rate ratio ^{[5]}  0.94 
95% Confidence Interval  0.82 to 1.07 
Standard Error of the mean  (0.06) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  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 
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  

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 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ttest, 2 sided 
P Value ^{[4]}  0.8624 
Rate ratio ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  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 Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 [ Time Frame: Month 1 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 
Measure Description  Estimated FEV1 before bronchodilator at Month 1 
Time Frame  Month 1 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
23. Secondary:  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 [ Time Frame: Month 1 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator 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 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
24. Secondary:  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 [ Time Frame: Month 6 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator 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 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
25. Secondary:  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 [ Time Frame: Month 6 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 
Measure Description  No text entered. 
Time Frame  Month 6 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
26. Secondary:  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 [ Time Frame: Month 12 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 
Measure Description  No text entered. 
Time Frame  Month 12 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
27. Secondary:  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 [ Time Frame: Month 12 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 
Measure Description  No text entered. 
Time Frame  Month 12 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Median Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
28. Secondary:  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 [ Time Frame: Month 18 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 
Measure Description  No text entered. 
Time Frame  Month 18 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
29. Secondary:  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 [ Time Frame: Month 18 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 
Measure Description  No text entered. 
Time Frame  Month 18 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
30. Secondary:  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 [ Time Frame: Month 24 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 
Measure Description  No text entered. 
Time Frame  Month 24 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
31. Secondary:  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 [ Time Frame: Month 24 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 
Measure Description  No text entered. 
Time Frame  Month 24 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
32. Secondary:  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 [ Time Frame: Month 30 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 
Measure Description  No text entered. 
Time Frame  Month 30 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
33. Secondary:  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 [ Time Frame: Month 30 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 
Measure Description  No text entered. 
Time Frame  Month 30 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
34. Secondary:  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 [ Time Frame: Month 36 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 
Measure Description  No text entered. 
Time Frame  Month 36 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
35. Secondary:  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 [ Time Frame: Month 36 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 
Measure Description  No text entered. 
Time Frame  Month 36 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
36. Secondary:  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 [ Time Frame: Month 42 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 
Measure Description  No text entered. 
Time Frame  Month 42 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
37. Secondary:  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 [ Time Frame: Month 42 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 
Measure Description  Estimated FEV1 after bronchodilator at Month 42 
Time Frame  Month 42 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
38. Secondary:  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 [ Time Frame: Month 48 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 
Measure Description  No text entered. 
Time Frame  Month 48 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
39. Secondary:  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 [ Time Frame: Month 48 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 
Measure Description  No text entered. 
Time Frame  Month 48 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
40. Secondary:  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 1 [ Time Frame: Month 1 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 1 
Measure Description  No text entered. 
Time Frame  Month 1 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Vital Capacity (FVC) at Month 1
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
41. Secondary:  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 1 [ Time Frame: Month 1 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 1 
Measure Description  No text entered. 
Time Frame  Month 1 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Vital Capacity (FVC) at Month 1
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
42. Secondary:  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 6 [ Time Frame: Month 6 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 6 
Measure Description  No text entered. 
Time Frame  Month 6 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Vital Capacity (FVC) at Month 6
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
43. Secondary:  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 6 [ Time Frame: Month 6 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 6 
Measure Description  No text entered. 
Time Frame  Month 6 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Vital Capacity (FVC) at Month 6
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
44. Secondary:  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 12 [ Time Frame: Month 12 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 12 
Measure Description  No text entered. 
Time Frame  Month 12 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Vital Capacity (FVC) at Month 12
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
45. Secondary:  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 12 [ Time Frame: Month 12 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 12 
Measure Description  No text entered. 
Time Frame  Month 12 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Vital Capacity (FVC) at Month 12
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
46. Secondary:  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 18 [ Time Frame: Month 18 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 18 
Measure Description  No text entered. 
Time Frame  Month 18 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Vital Capacity (FVC) at Month 18
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
47. Secondary:  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 18 [ Time Frame: Month 18 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 18 
Measure Description  No text entered. 
Time Frame  Month 18 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Vital Capacity (FVC) at Month 18
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
48. Secondary:  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 24 [ Time Frame: Month 24 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 24 
Measure Description  No text entered. 
Time Frame  Month 24 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Vital Capacity (FVC) at Month 24
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
49. Secondary:  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 24 [ Time Frame: Month 24 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 24 
Measure Description  No text entered. 
Time Frame  Month 24 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Vital Capacity (FVC) at Month 24
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
50. Secondary:  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 30 [ Time Frame: Month 30 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 30 
Measure Description  No text entered. 
Time Frame  Month 30 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Vital Capacity (FVC) at Month 30
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
51. Secondary:  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 30 [ Time Frame: Month 30 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 30 
Measure Description  No text entered. 
Time Frame  Month 30 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Vital Capacity (FVC) at Month 30
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  0.0005 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
52. Secondary:  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 36 [ Time Frame: Month 36 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 36 
Measure Description  No text entered. 
Time Frame  Month 36 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Vital Capacity (FVC) at Month 36
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
53. Secondary:  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 36 [ Time Frame: Month 36 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 36 
Measure Description  No text entered. 
Time Frame  Month 36 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Vital Capacity (FVC) at Month 36
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
54. Secondary:  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 42 [ Time Frame: Month 42 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 42 
Measure Description  No text entered. 
Time Frame  Month 42 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Vital Capacity (FVC) at Month 42
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
55. Secondary:  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 42 [ Time Frame: Month 42 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 42 
Measure Description  No text entered. 
Time Frame  Month 42 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Vital Capacity (FVC) at Month 42
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  0.0020 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
56. Secondary:  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 48 [ Time Frame: Month 48 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Forced Vital Capacity (FVC) at Month 48 
Measure Description  No text entered. 
Time Frame  Month 48 
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  

Participants Analyzed [Units: Participants] 
2363  2494 
Estimated Prebronchodilator 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 Prebronchodilator Forced Vital Capacity (FVC) at Month 48
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
57. Secondary:  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 48 [ Time Frame: Month 48 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Forced Vital Capacity (FVC) at Month 48 
Measure Description  No text entered. 
Time Frame  Month 48 
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  

Participants Analyzed [Units: Participants] 
2374  2516 
Estimated Postbronchodilator 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 Postbronchodilator Forced Vital Capacity (FVC) at Month 48
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  0.0365 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
58. Secondary:  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 1 [ Time Frame: Month 1 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 1 
Measure Description  No text entered. 
Time Frame  Month 1 
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  

Participants Analyzed [Units: Participants] 
2325  2447 
Estimated Prebronchodilator 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 Prebronchodilator Slow Vital Capacity (SVC) at Month 1
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
59. Secondary:  Estimated Postbronchodilator Slow Vital Capacity (SVC) at Month 1 [ Time Frame: Month 1 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Slow Vital Capacity (SVC) at Month 1 
Measure Description  No text entered. 
Time Frame  Month 1 
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  

Participants Analyzed [Units: Participants] 
2340  2467 
Estimated Postbronchodilator 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 Postbronchodilator Slow Vital Capacity (SVC) at Month 1
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  0.0002 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
60. Secondary:  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 6 [ Time Frame: Month 6 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 6 
Measure Description  No text entered. 
Time Frame  Month 6 
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  

Participants Analyzed [Units: Participants] 
2325  2447 
Estimated Prebronchodilator 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 Prebronchodilator Slow Vital Capacity (SVC) at Month 6
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
61. Secondary:  Estimated Postbronchodilator Slow Vital Capacity (SVC) at Month 6 [ Time Frame: Month 6 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Slow Vital Capacity (SVC) at Month 6 
Measure Description  No text entered. 
Time Frame  Month 6 
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  

Participants Analyzed [Units: Participants] 
2340  2467 
Estimated Postbronchodilator 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 Postbronchodilator Slow Vital Capacity (SVC) at Month 6
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  0.0018 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
62. Secondary:  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 12 [ Time Frame: Month 12 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 12 
Measure Description  No text entered. 
Time Frame  Month 12 
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  

Participants Analyzed [Units: Participants] 
2325  2447 
Estimated Prebronchodilator 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 Prebronchodilator Slow Vital Capacity (SVC) at Month 12
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
63. Secondary:  Estimated Postbronchodilator Slow Vital Capacity (SVC) at Month 12 [ Time Frame: Month 12 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Slow Vital Capacity (SVC) at Month 12 
Measure Description  No text entered. 
Time Frame  Month 12 
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  

Participants Analyzed [Units: Participants] 
2340  2467 
Estimated Postbronchodilator 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 Postbronchodilator Slow Vital Capacity (SVC) at Month 12
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  0.0069 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
64. Secondary:  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 18 [ Time Frame: Month 18 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 18 
Measure Description  No text entered. 
Time Frame  Month 18 
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  

Participants Analyzed [Units: Participants] 
2325  2447 
Estimated Prebronchodilator 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 Prebronchodilator Slow Vital Capacity (SVC) at Month 18
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
65. Secondary:  Estimated Postbronchodilator Slow Vital Capacity (SVC) at Month 18 [ Time Frame: Month 18 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Slow Vital Capacity (SVC) at Month 18 
Measure Description  No text entered. 
Time Frame  Month 18 
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  

Participants Analyzed [Units: Participants] 
2340  2467 
Estimated Postbronchodilator 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 Postbronchodilator Slow Vital Capacity (SVC) at Month 18
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  0.0020 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
66. Secondary:  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 24 [ Time Frame: Month 24 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 24 
Measure Description  No text entered. 
Time Frame  Month 24 
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  

Participants Analyzed [Units: Participants] 
2325  2447 
Estimated Prebronchodilator 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 Prebronchodilator Slow Vital Capacity (SVC) at Month 24
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
67. Secondary:  Estimated Postbronchodilator Slow Vital Capacity (SVC) at Month 24 [ Time Frame: Month 24 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Slow Vital Capacity (SVC) at Month 24 
Measure Description  No text entered. 
Time Frame  Month 24 
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  

Participants Analyzed [Units: Participants] 
2340  2467 
Estimated Postbronchodilator 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 Postbronchodilator Slow Vital Capacity (SVC) at Month 24
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  0.0165 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
68. Secondary:  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 30 [ Time Frame: Month 30 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 30 
Measure Description  No text entered. 
Time Frame  Month 30 
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  

Participants Analyzed [Units: Participants] 
2325  2447 
Estimated Prebronchodilator 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 Prebronchodilator Slow Vital Capacity (SVC) at Month 30
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  <.0001 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
69. Secondary:  Estimated Postbronchodilator Slow Vital Capacity (SVC) at Month 30 [ Time Frame: Month 30 ] 
Measure Type  Secondary 

Measure Title  Estimated Postbronchodilator Slow Vital Capacity (SVC) at Month 30 
Measure Description  No text entered. 
Time Frame  Month 30 
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  

Participants Analyzed [Units: Participants] 
2340  2467 
Estimated Postbronchodilator 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 Postbronchodilator Slow Vital Capacity (SVC) at Month 30
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  ANOVA 
P Value ^{[4]}  0.0248 
Mean Difference (Final Values) ^{[5]}  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]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
Repeated measures ANOVA  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
70. Secondary:  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 36 [ Time Frame: Month 36 ] 
Measure Type  Secondary 

Measure Title  Estimated Prebronchodilator Slow Vital Capacity (SVC) at Month 36 
Measure Description  No text entered. 
Time Frame  Month 36 
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