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

This study has been completed.

Sponsor:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT00144339

First Posted: September 5, 2005

Last Update Posted: May 20, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Information provided by:

Boehringer Ingelheim

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Results First Submitted: February 21, 2009

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 |
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09 Jan 2003 – 22 Feb 2008; 490 centers in 37 countries |

Pre-Assignment Details

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

Reporting Groups

Description | |
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Placebo | once daily |

Tiotropium Bromide Inhalation Capsules 18 mcg | once daily |

Participant Flow: Overall Study

Placebo | Tiotropium Bromide Inhalation Capsules 18 mcg | |
---|---|---|

STARTED | 3006 | 2986 |

COMPLETED | 1648 | 1887 |

NOT COMPLETED | 1358 | 1099 |

Adverse Event | 746 | 627 |

Protocol Violation | 75 | 48 |

Withdrawal by Subject | 403 | 300 |

Lost to Follow-up | 76 | 64 |

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

Measure Type | Primary |
---|---|

Measure Title | Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years |

Measure Description | Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1. |

Time Frame | From day 30 to 4 years |

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 |

Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years [Units: Ml/year] Mean (Standard Error) |
-30 (1) | -30 (1) |

Statistical Analysis 1 for Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
t-test, 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Random-effects model | |

[4] | Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: |

No text entered. | |

[5] | Other relevant estimation information: |

Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model |

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

Measure Type | Primary |
---|---|

Measure Title | Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years |

Measure Description | Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1. |

Time Frame | From day 30 to 4 years |

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 |

Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years [Units: Ml/year] Mean (Standard Error) |
-42 (1) | -40 (1) |

Statistical Analysis 1 for Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
t-test, 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Random-effects model | |

[4] | Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: |

No text entered. | |

[5] | Other relevant estimation information: |

Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model |

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

Measure Type | Secondary |
---|---|

Measure Title | Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment |

Measure Description | Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1 |

Time Frame | Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. |

Population Description

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 |

Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [Units: Ml/year] Median (Standard Error) |
-17 (2) | -15 (2) |

Statistical Analysis 1 for Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Wilcoxon Rank-sum 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 non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment |

Measure Description | Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1 |

Time Frame | Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days |

Population Description

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 |

Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [Units: Ml/year] Median (Standard Error) |
-32 (2) | -27 (2) |

Statistical Analysis 1 for Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Wilcoxon Rank-sum 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 non-inferiority 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] | |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years |

Measure Description | Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC |

Time Frame | From day 30 to 4 years |

Population Description

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 |

Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years [Units: Ml/year] Mean (Standard Error) |
-39 (3) | -43 (3) |

Statistical Analysis 1 for Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
t-test, 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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

Measure Type | Secondary |
---|---|

Measure Title | Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years |

Measure Description | Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC |

Time Frame | From day 30 to 4 years |

Population Description

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 |

Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years [Units: Ml/year] Mean (Standard Error) |
-61 (3) | -61 (3) |

Statistical Analysis 1 for Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
t-test, 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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

Measure Type | Secondary |
---|---|

Measure Title | Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years |

Measure Description | Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC |

Time Frame | From day 30 to 4 years |

Population Description

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 |

Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years [Units: Ml/year] Mean (Standard Error) |
-41 (3) | -47 (3) |

Statistical Analysis 1 for Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
t-test, 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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

Measure Type | Secondary |
---|---|

Measure Title | Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years |

Measure Description | Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC |

Time Frame | From day 30 to 4 years |

Population Description

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 |

Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years [Units: Ml/year] Mean (Standard Error) |
-65 (3) | -66 (3) |

Statistical Analysis 1 for Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
t-test, 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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

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]} |
t-test, 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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

Measure Type | Secondary |
---|---|

Measure Title | Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment |

Measure Description | Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC |

Time Frame | Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. |

Population Description

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 |

Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [Units: Ml/year] Median (Standard Error) |
-12 (4) | -10 (3) |

Statistical Analysis 1 for Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Wilcoxon Rank-sum 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 non-inferiority 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] | |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment |

Measure Description | Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC |

Time Frame | Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days |

Population Description

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 |

Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [Units: Ml/year] Median (Standard Error) |
-40 (4) | -40 (3) |

Statistical Analysis 1 for Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Wilcoxon Rank-sum 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

[4] | |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment |

Measure Description | Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC |

Time Frame | Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days |

Population Description

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 |

Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [Units: Ml/year] Median (Standard Error) |
-17 (4) | -17 (4) |

Statistical Analysis 1 for Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Wilcoxon Rank-sum 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

[4] | |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment |

Measure Description | Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC |

Time Frame | Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days |

Population Description

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 |

Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [Units: Ml/year] Median (Standard Error) |
-46 (4) | -42 (3) |

Statistical Analysis 1 for Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Wilcoxon Rank-sum 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

[4] | |

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

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 non-inferiority 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] | |

No text entered. | |

[5] | Other relevant estimation information: |

Median estimated by Kaplan-Meier estimates; hazard ratio shown as tio vs. placebo |

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

Measure Type | Secondary |
---|---|

Measure Title | Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year |

Measure Description | No text entered. |

Time Frame | Day 1 to 4 years |

Population Description

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]} |
t-test, 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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

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]} |
t-test, 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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

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]} |
t-test, 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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

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]} |
t-test, 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 |

Measure Description | Estimated FEV1 before bronchodilator at Month 1 |

Time Frame | Month 1 |

Population Description

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 Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 [Units: L] Mean (Standard Error) |
1.134 (0.004) | 1.221 (0.004) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 |

Measure Description | Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1 |

Time Frame | Month 1 |

Population Description

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 Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 [Units: L] Mean (Standard Error) |
1.372 (0.004) | 1.418 (0.004) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 |

Measure Description | Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6 |

Time Frame | Month 6 |

Population Description

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 Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 [Units: L] Mean (Standard Error) |
1.126 (0.004) | 1.225 (0.004) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 |

Measure Description | No text entered. |

Time Frame | Month 6 |

Population Description

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 Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 [Units: L] Mean (Standard Deviation) |
1.365 (0.004) | 1.423 (0.004) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 |

Measure Description | No text entered. |

Time Frame | Month 12 |

Population Description

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 Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 [Units: L] Mean (Standard Error) |
1.111 (0.004) | 1.213 (0.004) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 |

Measure Description | No text entered. |

Time Frame | Month 12 |

Population Description

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 Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 [Units: L] Mean (Standard Error) |
1.345 (0.004) | 1.398 (0.004) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 |

Measure Description | No text entered. |

Time Frame | Month 18 |

Population Description

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 Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 [Units: L] Mean (Standard Error) |
1.101 (0.005) | 1.192 (0.005) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 |

Measure Description | No text entered. |

Time Frame | Month 18 |

Population Description

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 Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 [Units: L] Mean (Standard Error) |
1.326 (0.005) | 1.379 (0.005) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 |

Measure Description | No text entered. |

Time Frame | Month 24 |

Population Description

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 Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 [Units: L] Mean (Standard Error) |
1.079 (0.005) | 1.173 (0.005) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 |

Measure Description | No text entered. |

Time Frame | Month 24 |

Population Description

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 Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 [Units: L] Mean (Standard Error) |
1.294 (0.005) | 1.356 (0.005) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 |

Measure Description | No text entered. |

Time Frame | Month 30 |

Population Description

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 Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 [Units: L] Mean (Standard Error) |
1.061 (0.005) | 1.156 (0.005) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 |

Measure Description | No text entered. |

Time Frame | Month 30 |

Population Description

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 Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 [Units: L] Mean (Standard Error) |
1.274 (0.005) | 1.335 (0.005) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 |

Measure Description | No text entered. |

Time Frame | Month 36 |

Population Description

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 Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 [Units: L] Mean (Standard Error) |
1.045 (0.005) | 1.144 (0.005) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 |

Measure Description | No text entered. |

Time Frame | Month 36 |

Population Description

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 Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 [Units: L] Mean (Standard Error) |
1.250 (0.005) | 1.315 (0.005) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 |

Measure Description | No text entered. |

Time Frame | Month 42 |

Population Description

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 Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 [Units: L] Mean (Standard Error) |
1.034 (0.005) | 1.129 (0.005) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 |

Measure Description | Estimated FEV1 after bronchodilator at Month 42 |

Time Frame | Month 42 |

Population Description

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 Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 [Units: L] Mean (Standard Error) |
1.236 (0.006) | 1.297 (0.005) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 |

Measure Description | No text entered. |

Time Frame | Month 48 |

Population Description

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 Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 [Units: L] Mean (Standard Error) |
1.024 (0.006) | 1.112 (0.005) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 |

Measure Description | No text entered. |

Time Frame | Month 48 |

Population Description

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 Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 [Units: L] Mean (Standard Error) |
1.219 (0.006) | 1.268 (0.006) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1 |

Measure Description | No text entered. |

Time Frame | Month 1 |

Population Description

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 Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1 [Units: L] Mean (Standard Error) |
2.667 (0.008) | 2.856 (0.008) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1 |

Measure Description | No text entered. |

Time Frame | Month 1 |

Population Description

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 Post-bronchodilator Forced Vital Capacity (FVC) at Month 1 [Units: L] Mean (Standard Error) |
3.149 (0.007) | 3.204 (0.006) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6 |

Measure Description | No text entered. |

Time Frame | Month 6 |

Population Description

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 Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6 [Units: L] Mean (Standard Error) |
2.658 (0.009) | 2.862 (0.008) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6 |

Measure Description | No text entered. |

Time Frame | Month 6 |

Population Description

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 Post-bronchodilator Forced Vital Capacity (FVC) at Month 6 [Units: L] Mean (Standard Error) |
3.137 (0.008) | 3.193 (0.007) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12 |

Measure Description | No text entered. |

Time Frame | Month 12 |

Population Description

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 Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12 [Units: L] Mean (Standard Error) |
2.640 (0.009) | 2.838 (0.009) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12 |

Measure Description | No text entered. |

Time Frame | Month 12 |

Population Description

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 Post-bronchodilator Forced Vital Capacity (FVC) at Month 12 [Units: L] Mean (Standard Error) |
3.110 (0.008) | 3.158 (0.008) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18 |

Measure Description | No text entered. |

Time Frame | Month 18 |

Population Description

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 Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18 [Units: L] Mean (Standard Error) |
2.622 (0.010) | 2.816 (0.010) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18 |

Measure Description | No text entered. |

Time Frame | Month 18 |

Population Description

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 Post-bronchodilator Forced Vital Capacity (FVC) at Month 18 [Units: L] Mean (Standard Error) |
3.075 (0.009) | 3.126 (0.009) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24 |

Measure Description | No text entered. |

Time Frame | Month 24 |

Population Description

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 Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24 [Units: L] Mean (Standard Error) |
2.597 (0.010) | 2.785 (0.010) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24 |

Measure Description | No text entered. |

Time Frame | Month 24 |

Population Description

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 Post-bronchodilator Forced Vital Capacity (FVC) at Month 24 [Units: L] Mean (Standard Error) |
3.036 (0.009) | 3.095 (0.009) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30 |

Measure Description | No text entered. |

Time Frame | Month 30 |

Population Description

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 Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30 [Units: L] Mean (Standard Error) |
2.572 (0.010) | 2.757 (0.010) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 |

Measure Description | No text entered. |

Time Frame | Month 30 |

Population Description

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 Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 [Units: L] Mean (Standard Error) |
3.010 (0.010) | 3.057 (0.009) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36 |

Measure Description | No text entered. |

Time Frame | Month 36 |

Population Description

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 Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36 [Units: L] Mean (Standard Error) |
2.553 (0.011) | 2.753 (0.010) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36 |

Measure Description | No text entered. |

Time Frame | Month 36 |

Population Description

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 Post-bronchodilator Forced Vital Capacity (FVC) at Month 36 [Units: L] Mean (Standard Error) |
2.973 (0.010) | 3.038 (0.010) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42 |

Measure Description | No text entered. |

Time Frame | Month 42 |

Population Description

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 Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42 [Units: L] Mean (Standard Error) |
2.540 (0.011) | 2.724 (0.011) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42 |

Measure Description | No text entered. |

Time Frame | Month 42 |

Population Description

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 Post-bronchodilator Forced Vital Capacity (FVC) at Month 42 [Units: L] Mean (Standard Error) |
2.959 (0.011) | 3.005 (0.010) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48 |

Measure Description | No text entered. |

Time Frame | Month 48 |

Population Description

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 Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48 [Units: L] Mean (Standard Error) |
2.532 (0.011) | 2.702 (0.011) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48 |

Measure Description | No text entered. |

Time Frame | Month 48 |

Population Description

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 Post-bronchodilator Forced Vital Capacity (FVC) at Month 48 [Units: L] Mean (Standard Error) |
2.929 (0.011) | 2.961 (0.010) |

Statistical Analysis 1 for Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1 |

Measure Description | No text entered. |

Time Frame | Month 1 |

Population Description

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 Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1 [Units: L] Mean (Standard Error) |
2.847 (0.008) | 3.017 (0.008) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1 |

Measure Description | No text entered. |

Time Frame | Month 1 |

Population Description

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 Post-bronchodilator Slow Vital Capacity (SVC) at Month 1 [Units: L] Mean (Standard Error) |
3.280 (0.007) | 3.318 (0.007) |

Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6 |

Measure Description | No text entered. |

Time Frame | Month 6 |

Population Description

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 Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6 [Units: L] Mean (Standard Error) |
2.841 (0.009) | 3.027 (0.009) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6 |

Measure Description | No text entered. |

Time Frame | Month 6 |

Population Description

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 Post-bronchodilator Slow Vital Capacity (SVC) at Month 6 [Units: L] Mean (Standard Error) |
3.268 (0.008) | 3.304 (0.008) |

Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12 |

Measure Description | No text entered. |

Time Frame | Month 12 |

Population Description

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 Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12 [Units: L] Mean (Standard Error) |
2.820 (0.009) | 2.996 (0.009) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12 |

Measure Description | No text entered. |

Time Frame | Month 12 |

Population Description

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 Post-bronchodilator Slow Vital Capacity (SVC) at Month 12 [Units: L] Mean (Standard Error) |
3.228 (0.008) | 3.260 (0.008) |

Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18 |

Measure Description | No text entered. |

Time Frame | Month 18 |

Population Description

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 Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18 [Units: L] Mean (Standard Error) |
2.811 (0.010) | 2.965 (0.010) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18 |

Measure Description | No text entered. |

Time Frame | Month 18 |

Population Description

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 Post-bronchodilator Slow Vital Capacity (SVC) at Month 18 [Units: L] Mean (Standard Error) |
3.195 (0.009) | 3.234 (0.009) |

Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24 |

Measure Description | No text entered. |

Time Frame | Month 24 |

Population Description

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 Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24 [Units: L] Mean (Standard Error) |
2.775 (0.010) | 2.942 (0.010) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24 |

Measure Description | No text entered. |

Time Frame | Month 24 |

Population Description

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 Post-bronchodilator Slow Vital Capacity (SVC) at Month 24 [Units: L] Mean (Standard Error) |
3.157 (0.009) | 3.189 (0.009) |

Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30 |

Measure Description | No text entered. |

Time Frame | Month 30 |

Population Description

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 Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30 [Units: L] Mean (Standard Error) |
2.738 (0.011) | 2.908 (0.010) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30 |

Measure Description | No text entered. |

Time Frame | Month 30 |

Population Description

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 Post-bronchodilator Slow Vital Capacity (SVC) at Month 30 [Units: L] Mean (Standard Error) |
3.126 (0.010) | 3.157 (0.010) |

Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30

Groups ^{[1]} |
All groups |
---|---|

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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36 |

Measure Description | No text entered. |

Time Frame | Month 36 |

Population Description

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 Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36 [Units: L] Mean (Standard Error) |
2.731 (0.011) | 2.897 (0.010) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
ANOVA |

P Value ^{[4]} |
<.0001 |

Mean Difference (Final Values) ^{[5]} |
0.166 |

95% Confidence Interval | 0.136 to 0.196 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

No text entered. | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36 |

Measure Description | No text entered. |

Time Frame | Month 36 |

Population Description

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 Post-bronchodilator Slow Vital Capacity (SVC) at Month 36 [Units: L] Mean (Standard Error) |
3.086 (0.010) | 3.136 (0.010) |

Statistical Analysis 1 for Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
ANOVA |

P Value ^{[4]} |
0.0004 |

Mean Difference (Final Values) ^{[5]} |
0.050 |

95% Confidence Interval | 0.022 to 0.078 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

No text entered. | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42 |

Measure Description | No text entered. |

Time Frame | Month 42 |

Population Description

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 Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42 [Units: L] Mean (Standard Error) |
2.713 (0.011) | 2.875 (0.011) |

Statistical Analysis 1 for Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42

Groups ^{[1]} |
All groups |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
ANOVA |

P Value ^{[4]} |
<.0001 |

Mean Difference (Final Values) ^{[5]} |
0.161 |

95% Confidence Interval | 0.130 to 0.192 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

No text entered. | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

Repeated measures ANOVA | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

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

Measure Type | Secondary |
---|---|

Measure Title | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42 |

Measure Description | No text entered. |

Time Frame | Month 42 |

Population Description

No text entered. |