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

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.
ClinicalTrials.gov Identifier: NCT00144339
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : August 17, 2009
Last Update Posted : May 20, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: tiotropium
Drug: placebo
Enrollment 5993
Recruitment Details 09 Jan 2003 – 22 Feb 2008; 490 centers in 37 countries
Pre-assignment Details  
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description once daily once daily
Period Title: Overall Study
Started 3006 2986
Completed 1648 1887
Not Completed 1358 1099
Reason Not Completed
Adverse Event             746             627
Protocol Violation             75             48
Withdrawal by Subject             403             300
Lost to Follow-up             76             64
Other             58             60
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg Total
Hide Arm/Group Description Once daily Once daily Total of all reporting groups
Overall Number of Baseline Participants 3006 2986 5992
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3006 participants 2986 participants 5992 participants
64.52  (8.48) 64.50  (8.41) 64.51  (8.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3006 participants 2986 participants 5992 participants
Female
784
  26.1%
735
  24.6%
1519.0
Male
2222
  73.9%
2251
  75.4%
4473.0
1.Primary Outcome
Title Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2413 2557
Mean (Standard Error)
Unit of Measure: ml/year
-30  (1) -30  (1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments Linear random effects model
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9524
Comments [Not Specified]
Method t-test, 2 sided
Comments Random-effects model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Confidence Interval 95%
-4 to 4
Parameter Dispersion
Type: Standard Error of the mean
Value: 2
Estimation Comments Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model
2.Primary Outcome
Title Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2410 2554
Mean (Standard Error)
Unit of Measure: ml/year
-42  (1) -40  (1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments Linear random effects model
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2074
Comments [Not Specified]
Method t-test, 2 sided
Comments Random-effects model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2
Confidence Interval 95%
-2 to 6
Parameter Dispersion
Type: Standard Error of the mean
Value: 2
Estimation Comments Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model
3.Secondary Outcome
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
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 1618 1803
Median (Standard Error)
Unit of Measure: ml/year
-17  (2) -15  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2488
Comments [Not Specified]
Method Wilcoxon Rank-sum test
Comments Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between
4.Secondary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 1613 1805
Median (Standard Error)
Unit of Measure: ml/year
-32  (2) -27  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0145
Comments [Not Specified]
Method Wilcoxon Rank-sum test
Comments Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between
5.Secondary Outcome
Title Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2413 2557
Mean (Standard Error)
Unit of Measure: ml/year
-39  (3) -43  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments Linear random effects model
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2990
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4
Confidence Interval 95%
-12 to 4
Parameter Dispersion
Type: Standard Error of the mean
Value: 4
Estimation Comments Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model
6.Secondary Outcome
Title Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2410 2554
Mean (Standard Error)
Unit of Measure: ml/year
-61  (3) -61  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments Linear random effects model
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8375
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1
Confidence Interval 95%
-9 to 7
Parameter Dispersion
Type: Standard Error of the mean
Value: 4
Estimation Comments Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model
7.Secondary Outcome
Title Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2531
Mean (Standard Error)
Unit of Measure: ml/year
-41  (3) -47  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments Linear random effects model
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1143
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -6
Confidence Interval 95%
-14 to 2
Parameter Dispersion
Type: Standard Error of the mean
Value: 4
Estimation Comments Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model
8.Secondary Outcome
Title Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2383 2527
Mean (Standard Error)
Unit of Measure: ml/year
-65  (3) -66  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments Linear random effects model
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7870
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -1
Confidence Interval 95%
-9 to 7
Parameter Dispersion
Type: Standard Error of the mean
Value: 4
Estimation Comments Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model
9.Secondary Outcome
Title Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2362 2505
Mean (Standard Error)
Unit of Measure: Score on scale per year
1.21  (0.09) 1.25  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments Linear random effects model
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7840
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval 95%
-0.2 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model
10.Secondary Outcome
Title Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 1618 1803
Median (Standard Error)
Unit of Measure: ml/year
-12  (4) -10  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2705
Comments [Not Specified]
Method Wilcoxon Rank-sum test
Comments Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between
11.Secondary Outcome
Title Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 1613 1805
Median (Standard Error)
Unit of Measure: ml/year
-40  (4) -40  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.306
Comments [Not Specified]
Method Wilcoxon Rank-sum test
Comments Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between
12.Secondary Outcome
Title Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 1562 1706
Median (Standard Error)
Unit of Measure: ml/year
-17  (4) -17  (4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8103
Comments [Not Specified]
Method Wilcoxon Rank-sum test
Comments Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between
13.Secondary Outcome
Title Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 1540 1711
Median (Standard Error)
Unit of Measure: ml/year
-46  (4) -42  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9814
Comments [Not Specified]
Method Wilcoxon Rank-sum test
Comments Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between
14.Secondary Outcome
Title Time to First Exacerbation
Hide Description Chronic obstructive pulmonary disease (COPD) exacerbation
Time Frame From Day 1 to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 3006 2986
Median (95% Confidence Interval)
Unit of Measure: months
12.51
(11.53 to 13.79)
16.65
(14.88 to 17.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments Cox regression
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments Cox regression with treatment
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval 95%
0.81 to 0.91
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments Median estimated by Kaplan-Meier estimates; hazard ratio shown as tio vs. placebo
15.Secondary Outcome
Title Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year
Hide Description [Not Specified]
Time Frame Day 1 to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 3006 2986
Mean (Standard Error)
Unit of Measure: number per patient year
0.85  (0.02) 0.73  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments Poisson regression adjusted for overdispersion and treatment exposure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.86
Confidence Interval 95%
0.81 to 0.91
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments Ratio calculated as estimated number of events in tio/number of events in placebo
16.Secondary Outcome
Title Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Hide Description [Not Specified]
Time Frame Day 1 to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 3006 2986
Measure Type: Number
Unit of Measure: Participants
Number of patients 2049 2001
Percentage of patients 68.2 67
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3481
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
17.Secondary Outcome
Title Number of Exacerbation Days Per Patient Year
Hide Description Number of exacerbation days normalized by treatment exposure
Time Frame Day 1 to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 3006 2986
Mean (Standard Error)
Unit of Measure: days/patient year
13.64  (0.35) 12.11  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments Poisson regression adjusted for overdispersion and treatment exposure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.89
Confidence Interval 95%
0.83 to 0.95
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments 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 Outcome
Title Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)
Hide Description [Not Specified]
Time Frame Day 1 to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 3006 2986
Median (95% Confidence Interval)
Unit of Measure: months
28.64
(26.08 to 31.82)
35.89
(23.38 to 39.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1766
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
19.Secondary Outcome
Title Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization
Hide Description [Not Specified]
Time Frame From Day 1 to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 3006 2986
Measure Type: Number
Unit of Measure: Participants
Number of patients 811 759
Percentage of patients 27 25.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments Cox regression
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval 95%
0.78 to 0.95
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.04
Estimation Comments Hazard ratio shown as tiotropium bromide vs. placebo
20.Secondary Outcome
Title Number of Exacerbation Leading to Hospitalization
Hide Description Estimated number of exacerbations leading to hospitalizations per patient year
Time Frame From Day 1 to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 3006 2986
Measure Type: Number
Unit of Measure: Number per patient year
0.16 0.15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3413
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.94
Confidence Interval 95%
0.82 to 1.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments Ratio of estimated number of events between tiotropium bromide and placebo
21.Secondary Outcome
Title Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 3006 2986
Mean (Standard Error)
Unit of Measure: days/patient year
3.13  (0.17) 3.17  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8624
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.01
Confidence Interval 95%
0.87 to 1.18
Estimation Comments Ratio of estimated number of days of chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization between tio and placebo
22.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
Hide Description Estimated FEV1 before bronchodilator at Month 1
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
1.134  (0.004) 1.221  (0.004)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.087
Confidence Interval 95%
0.077 to 0.098
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
Hide Description Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
1.372  (0.004) 1.418  (0.004)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.047
Confidence Interval 95%
0.037 to 0.057
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
Hide Description Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
1.126  (0.004) 1.225  (0.004)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.099
Confidence Interval 95%
0.087 to 0.110
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
Hide Description [Not Specified]
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Deviation)
Unit of Measure: L
1.365  (0.004) 1.423  (0.004)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.058
Confidence Interval 95%
0.047 to 0.069
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Hide Description [Not Specified]
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
1.111  (0.004) 1.213  (0.004)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.103
Confidence Interval 95%
0.091 to 0.115
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Hide Description [Not Specified]
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
1.345  (0.004) 1.398  (0.004)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.054
Confidence Interval 95%
0.042 to 0.065
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Hide Description [Not Specified]
Time Frame Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
1.101  (0.005) 1.192  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.091
Confidence Interval 95%
0.078 to 0.104
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Hide Description [Not Specified]
Time Frame Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
1.326  (0.005) 1.379  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.053
Confidence Interval 95%
0.040 to 0.066
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Hide Description [Not Specified]
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
1.079  (0.005) 1.173  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.094
Confidence Interval 95%
0.081 to 0.107
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Hide Description [Not Specified]
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
1.294  (0.005) 1.356  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.062
Confidence Interval 95%
0.049 to 0.075
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Hide Description [Not Specified]
Time Frame Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
1.061  (0.005) 1.156  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.095
Confidence Interval 95%
0.081 to 0.109
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Hide Description [Not Specified]
Time Frame Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
1.274  (0.005) 1.335  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.061
Confidence Interval 95%
0.047 to 0.075
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Hide Description [Not Specified]
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
1.045  (0.005) 1.144  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.099
Confidence Interval 95%
0.085 to 0.114
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Hide Description [Not Specified]
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
1.250  (0.005) 1.315  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.065
Confidence Interval 95%
0.051 to 0.080
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
Hide Description [Not Specified]
Time Frame Month 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
1.034  (0.005) 1.129  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.095
Confidence Interval 95%
0.080 to 0.110
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
Hide Description Estimated FEV1 after bronchodilator at Month 42
Time Frame Month 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
1.236  (0.006) 1.297  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.061
Confidence Interval 95%
0.045 to 0.076
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Hide Description [Not Specified]
Time Frame Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
1.024  (0.006) 1.112  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.088
Confidence Interval 95%
0.073 to 0.103
Estimation Comments [Not Specified]
39.Secondary Outcome
Title Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Hide Description [Not Specified]
Time Frame Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
1.219  (0.006) 1.268  (0.006)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.049
Confidence Interval 95%
0.033 to 0.065
Estimation Comments [Not Specified]
40.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1
Hide Description [Not Specified]
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
2.667  (0.008) 2.856  (0.008)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.190
Confidence Interval 95%
0.168 to 0.211
Estimation Comments [Not Specified]
41.Secondary Outcome
Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1
Hide Description [Not Specified]
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
3.149  (0.007) 3.204  (0.006)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.055
Confidence Interval 95%
0.037 to 0.073
Estimation Comments [Not Specified]
42.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6
Hide Description [Not Specified]
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
2.658  (0.009) 2.862  (0.008)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.204
Confidence Interval 95%
0.180 to 0.228
Estimation Comments [Not Specified]
43.Secondary Outcome
Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6
Hide Description [Not Specified]
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
3.137  (0.008) 3.193  (0.007)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.055
Confidence Interval 95%
0.034 to 0.076
Estimation Comments [Not Specified]
44.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12
Hide Description [Not Specified]
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
2.640  (0.009) 2.838  (0.009)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.198
Confidence Interval 95%
0.173 to 0.222
Estimation Comments [Not Specified]
45.Secondary Outcome
Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12
Hide Description [Not Specified]
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
3.110  (0.008) 3.158  (0.008)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.048
Confidence Interval 95%
0.026 to 0.070
Estimation Comments [Not Specified]
46.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18
Hide Description [Not Specified]
Time Frame Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
2.622  (0.010) 2.816  (0.010)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.194
Confidence Interval 95%
0.167 to 0.221
Estimation Comments [Not Specified]
47.Secondary Outcome
Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18
Hide Description [Not Specified]
Time Frame Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
3.075  (0.009) 3.126  (0.009)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.050
Confidence Interval 95%
0.026 to 0.074
Estimation Comments [Not Specified]
48.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24
Hide Description [Not Specified]
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
2.597  (0.010) 2.785  (0.010)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.189
Confidence Interval 95%
0.161 to 0.216
Estimation Comments [Not Specified]
49.Secondary Outcome
Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24
Hide Description [Not Specified]
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
3.036  (0.009) 3.095  (0.009)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.059
Confidence Interval 95%
0.035 to 0.084
Estimation Comments [Not Specified]
50.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30
Hide Description [Not Specified]
Time Frame Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
2.572  (0.010) 2.757  (0.010)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.185
Confidence Interval 95%
0.157 to 0.213
Estimation Comments [Not Specified]
51.Secondary Outcome
Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30
Hide Description [Not Specified]
Time Frame Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
3.010  (0.010) 3.057  (0.009)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.047
Confidence Interval 95%
0.021 to 0.074
Estimation Comments [Not Specified]
52.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36
Hide Description [Not Specified]
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
2.553  (0.011) 2.753  (0.010)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.200
Confidence Interval 95%
0.170 to 0.229
Estimation Comments [Not Specified]
53.Secondary Outcome
Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36
Hide Description [Not Specified]
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
2.973  (0.010) 3.038  (0.010)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.065
Confidence Interval 95%
0.038 to 0.093
Estimation Comments [Not Specified]
54.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42
Hide Description [Not Specified]
Time Frame Month 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
2.540  (0.011) 2.724  (0.011)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.184
Confidence Interval 95%
0.154 to 0.215
Estimation Comments [Not Specified]
55.Secondary Outcome
Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42
Hide Description [Not Specified]
Time Frame Month 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
2.959  (0.011) 3.005  (0.010)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.046
Confidence Interval 95%
0.017 to 0.076
Estimation Comments [Not Specified]
56.Secondary Outcome
Title Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48
Hide Description [Not Specified]
Time Frame Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2363 2494
Mean (Standard Error)
Unit of Measure: L
2.532  (0.011) 2.702  (0.011)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.170
Confidence Interval 95%
0.139 to 0.201
Estimation Comments [Not Specified]
57.Secondary Outcome
Title Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48
Hide Description [Not Specified]
Time Frame Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2374 2516
Mean (Standard Error)
Unit of Measure: L
2.929  (0.011) 2.961  (0.010)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0365
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.032
Confidence Interval 95%
0.002 to 0.061
Estimation Comments [Not Specified]
58.Secondary Outcome
Title Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1
Hide Description [Not Specified]
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2325 2447
Mean (Standard Error)
Unit of Measure: L
2.847  (0.008) 3.017  (0.008)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.170
Confidence Interval 95%
0.147 to 0.192
Estimation Comments [Not Specified]
59.Secondary Outcome
Title Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1
Hide Description [Not Specified]
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2340 2467
Mean (Standard Error)
Unit of Measure: L
3.280  (0.007) 3.318  (0.007)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.038
Confidence Interval 95%
0.018 to 0.058
Estimation Comments [Not Specified]
60.Secondary Outcome
Title Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6
Hide Description [Not Specified]
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2325 2447
Mean (Standard Error)
Unit of Measure: L
2.841  (0.009) 3.027  (0.009)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.186
Confidence Interval 95%
0.161 to 0.210
Estimation Comments [Not Specified]
61.Secondary Outcome
Title Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6
Hide Description [Not Specified]
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2340 2467
Mean (Standard Error)
Unit of Measure: L
3.268  (0.008) 3.304  (0.008)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.037
Confidence Interval 95%
0.014 to 0.060
Estimation Comments [Not Specified]
62.Secondary Outcome
Title Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12
Hide Description [Not Specified]
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2325 2447
Mean (Standard Error)
Unit of Measure: L
2.820  (0.009) 2.996  (0.009)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.176
Confidence Interval 95%
0.151 to 0.201
Estimation Comments [Not Specified]
63.Secondary Outcome
Title Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12
Hide Description [Not Specified]
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tiotropium Bromide Inhalation Capsules 18 mcg
Hide Arm/Group Description:
Once daily
Once daily
Overall Number of Participants Analyzed 2340 2467
Mean (Standard Error)
Unit of Measure: L
3.228  (0.008) 3.260  (0.008)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium Bromide Inhalation Capsules 18 mcg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0069
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.032
Confidence Interval 95%
0.009 to 0.055
Estimation Comments [Not Specified]
64.Secondary Outcome
Title Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18
Hide Description [Not Specified]
Time Frame Month 18