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Trial record 36 of 10813 for:    Placebo AND once

Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

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: NCT00523991
Recruitment Status : Completed
First Posted : September 3, 2007
Results First Posted : December 29, 2011
Last Update Posted : May 20, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: tiotropium
Drug: Placebo
Enrollment 457
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description Placebo matching tiotropium via HandiHaler® + Pro Re Nata (PRN) albuterol 18 mcg tiotropium via HandiHaler® + PRN albuterol
Period Title: Overall Study
Started 219 238
Completed 198 211
Not Completed 21 27
Reason Not Completed
Adverse Event             6             5
Protocol Violation             1             4
Lost to Follow-up             4             1
Withdrawal by Subject             7             17
Other reason (not specified)             3             0
Arm/Group Title Placebo Tiotropium Total
Hide Arm/Group Description Placebo matching tiotropium via HandiHaler® + PRN albuterol 18 mcg tiotropium via HandiHaler® + PRN albuterol Total of all reporting groups
Overall Number of Baseline Participants 219 238 457
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 219 participants 238 participants 457 participants
62.3  (8.6) 61.2  (8.2) 61.7  (8.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 219 participants 238 participants 457 participants
18-44 years 8 7 15
45-64 years 121 151 272
>=65 years 90 80 170
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants 238 participants 457 participants
Female
72
  32.9%
72
  30.3%
144
  31.5%
Male
147
  67.1%
166
  69.7%
313
  68.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 219 participants 238 participants 457 participants
Black 6 4 10
White 213 234 447
1.Primary Outcome
Title Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)
Hide Description Change = Week 24 Value – Baseline Value
Time Frame baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres * hours
-0.06  (0.02) 0.16  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments

There was only one primary endpoint and the p-value was not adjusted for multiple comparisons.

Mean Difference (Final Values) means difference in LS-Means

Method ANCOVA
Comments The analysis of covariance model included treatment, site, and trough forced expiratory volume in 1 second at baseline in the model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.23
Confidence Interval 95%
0.18 to 0.27
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)
Hide Description Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
1.71  (0.45) 1.74  (0.46)
3.Secondary Outcome
Title Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)
Hide Description Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame Baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.03  (0.21) 0.12  (0.21)
4.Secondary Outcome
Title Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)
Hide Description Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame Baseline, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.06  (0.21) 0.09  (0.27)
5.Secondary Outcome
Title Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)
Hide Description Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame Baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
-0.08  (0.02) 0.06  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments Terms include treatment, site, and trough forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval 95%
0.09 to 0.18
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Peak Forced Expiratory Volume in 1 Second (Baseline)
Hide Description Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
1.71  (0.45) 1.74  (0.46)
7.Secondary Outcome
Title Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)
Hide Description Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time Frame Baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
0.09  (0.22) 0.31  (0.24)
8.Secondary Outcome
Title Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)
Hide Description Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time Frame Baseline, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
0.05  (0.24) 0.29  (0.28)
9.Secondary Outcome
Title Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)
Hide Description Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time Frame Baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
0.02  (0.02) 0.26  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments Terms include treatment, site, and peak forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.24
Confidence Interval 95%
0.19 to 0.29
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)
Hide Description Forced expiratory volume in 1 second (baseline, pre-dose)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
1.71  (0.45) 1.74  (0.46)
11.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)
Hide Description Forced expiratory volume in 1 second (baseline, 30 minutes)
Time Frame baseline, 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
1.73  (0.45) 1.87  (0.47)
12.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)
Hide Description Forced expiratory volume in 1 second (baseline, 60 minutes)
Time Frame baseline, 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
1.74  (0.47) 1.90  (0.47)
13.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)
Hide Description Forced expiratory volume in 1 second (baseline, 120 minutes)
Time Frame Baseline, 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
1.75  (0.48) 1.92  (0.49)
14.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)
Hide Description Forced expiratory volume in 1 second (baseline, 180 minutes)
Time Frame Baseline, 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
1.76  (0.48) 1.94  (0.48)
15.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)
Hide Description Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)
Time Frame baseline, week 8, pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.03  (0.21) 0.12  (0.21)
16.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)
Hide Description Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)
Time Frame Baseline, week 8, 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
0.00  (0.22) 0.20  (0.22)
17.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)
Hide Description Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)
Time Frame baseline, week 8, 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
0.01  (0.24) 0.22  (0.24)
18.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)
Hide Description Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)
Time Frame baseline, week 8, 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
0.01  (0.23) 0.24  (0.23)
19.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)
Hide Description Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)
Time Frame baseline, week 8, 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
0.01  (0.22) 0.24  (0.25)
20.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)
Hide Description Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)
Time Frame baseline, week 16, pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.06  (0.21) 0.09  (0.27)
21.Secondary Outcome
Title Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)
Hide Description Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)
Time Frame Baseline, week 16, 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.02  (0.24) 0.19  (0.27)
22.Secondary Outcome
Title Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)
Hide Description Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)
Time Frame baseline, week 16, 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.02  (0.24) 0.21  (0.27)
23.Secondary Outcome
Title Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)
Hide Description Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)
Time Frame baseline, week 16, 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.03  (0.24) 0.22  (0.28)
24.Secondary Outcome
Title Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)
Hide Description Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)
Time Frame baseline, week 16, 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.02  (0.24) 0.22  (0.28)
25.Secondary Outcome
Title Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)
Hide Description Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)
Time Frame baseline, week 24, pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
-0.08  (0.02) 0.06  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

Terms include treatment, site, and forced expiratory volume in 1 second at baseline

Mean Difference (Final Values) means difference in LSMeans

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval 95%
0.09 to 0.18
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)
Hide Description Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)
Time Frame baseline, week 24, 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
-0.05  (0.02) 0.15  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms include treatment, site, and forced expiratory volume in 1 second at baseline

Mean Difference (Final Values) means difference in LSMeans

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.20
Confidence Interval 95%
0.16 to 0.25
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)
Hide Description Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)
Time Frame baseline, week 24, 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
-0.05  (0.02) 0.18  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium vesus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms include treatment, site, and forced expiratory volume in 1 second at baseline

Mean Difference (Final Values) means difference in LSMeans

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.23
Confidence Interval 95%
0.18 to 0.28
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)
Hide Description Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)
Time Frame baseline, week 24, 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
-0.06  (0.02) 0.18  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms include treatment, site, and forced expiratory volume in 1 second at baseline

Mean Difference (Final Values) means difference in LSMeans

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.24
Confidence Interval 95%
0.20 to 0.29
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)
Hide Description Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)
Time Frame baseline, week 24, 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
-0.05  (0.02) 0.20  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms include treatment, site, and peak forced expiratory volume in 1 second at baseline

Mean Difference (Final Values) means difference in LSMeans

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval 95%
0.20 to 0.30
Estimation Comments [Not Specified]
30.Secondary Outcome
Title FVC AUC0-3 at Baseline
Hide Description Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres * hours
3.17  (0.82) 3.24  (0.81)
31.Secondary Outcome
Title FVC AUC0-3 at Week 8 Minus Baseline
Hide Description Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)
Time Frame baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres * hours
-0.01  (0.35) 0.28  (0.39)
32.Secondary Outcome
Title FVC AUC0-3 at Week 16 Minus Baseline
Hide Description Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)
Time Frame baseline, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres * hours
-0.06  (0.39) 0.24  (0.43)
33.Secondary Outcome
Title FVC AUC0-3 at Week 24 Minus Baseline
Hide Description Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)
Time Frame baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres * hours
-0.11  (0.03) 0.19  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments terms include treatment, site, and forced vital capacity area under the curve at baseline Mean Difference (Final Values) means difference in LSMeans
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.31
Confidence Interval 95%
0.24 to 0.38
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Trough Forced Vital Capacity (Baseline)
Hide Description Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
3.17  (0.82) 3.24  (0.81)
35.Secondary Outcome
Title Change From Baseline in Trough Forced Vital Capacity (at Week 8)
Hide Description Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.06  (0.33) 0.16  (0.38)
36.Secondary Outcome
Title Change From Baseline in Trough Forced Vital Capacity (at Week 16)
Hide Description Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame baseline, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.13  (0.37) 0.10  (0.42)
37.Secondary Outcome
Title Change From Baseline in Trough Forced Vital Capacity (at Week 24)
Hide Description Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
-0.14  (0.03) 0.07  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms include treatment, site, and trough forced vital capacity at baseline

Mean Difference (Final Values) means difference in LSMeans

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval 95%
0.14 to 0.28
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Peak Forced Vital Capacity (FVC) (Baseline)
Hide Description Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
3.17  (0.82) 3.24  (0.81)
39.Secondary Outcome
Title Change From Baseline in Peak Forced Vital Capacity (at Week 8)
Hide Description Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time Frame baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
0.13  (0.34) 0.43  (0.40)
40.Secondary Outcome
Title Change From Baseline in Peak Forced Vital Capacity (at Week 16)
Hide Description Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time Frame baseline, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
0.08  (0.40) 0.38  (0.44)
41.Secondary Outcome
Title Change From Baseline in Peak Forced Vital Capacity (at Week 24)
Hide Description Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time Frame baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
0.06  (0.04) 0.40  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms include treatment, site, and peak forced vital capacity at baseline

Mean Difference (Final Values) means difference in LSMeans

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval 95%
0.24 to 0.42
Estimation Comments [Not Specified]
42.Secondary Outcome
Title Forced Vital Capacity (Baseline, Pre-dose)
Hide Description Forced vital capacity (baseline, pre-dose)
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
3.17  (0.82) 3.24  (0.81)
43.Secondary Outcome
Title Forced Vital Capacity (Baseline, 30 Minutes)
Hide Description Forced vital capacity (baseline, 30 minutes)
Time Frame baseline, 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
3.20  (0.82) 3.45  (0.83)
44.Secondary Outcome
Title Forced Vital Capacity (Baseline, 60 Minutes)
Hide Description Forced vital capacity (baseline, 60 minutes)
Time Frame baseline, 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
3.22  (0.85) 3.48  (0.84)
45.Secondary Outcome
Title Forced Vital Capacity (Baseline, 120 Minutes)
Hide Description Forced vital capacity (baseline, 120 minutes)
Time Frame baseline, 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
3.21  (0.86) 3.49  (0.85)
46.Secondary Outcome
Title Forced Vital Capacity (Baseline, 180 Minutes)
Hide Description Forced vital capacity (baseline, 180 minutes)
Time Frame baseline, 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
3.21  (0.83) 3.50  (0.85)
47.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)
Hide Description Change from baseline in forced vital capacity (week 8, pre-dose)
Time Frame baseline, week 8, pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.06  (0.33) 0.16  (0.38)
48.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)
Hide Description Change from baseline in forced vital capacity (week 8, 30 minutes)
Time Frame baseline, week 8, 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
0.00  (0.35) 0.27  (0.40)
49.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)
Hide Description Change from baseline in forced vital capacity (week 8, 60 minutes)
Time Frame baseline, week 8, 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
0.00  (0.37) 0.29  (0.43)
50.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)
Hide Description Change from baseline in forced vital capacity (week 8, 120 minutes)
Time Frame baseline, week 8, 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.02  (0.39) 0.30  (0.40)
51.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)
Hide Description Change from baseline in forced vital capacity (week 8, 180 minutes)
Time Frame baseline, week 8, 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
0.00  (0.37) 0.30  (0.43)
52.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)
Hide Description Change from baseline in forced vital capacity (week 16, pre-dose)
Time Frame baseline, week 16, pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.13  (0.37) 0.10  (0.42)
53.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)
Hide Description Change from baseline in forced vital capacity (week 16, 30 minutes)
Time Frame baseline, week 16, 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.06  (0.39) 0.24  (0.45)
54.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)
Hide Description Change from baseline in forced vital capacity (week 16, 60 minutes)
Time Frame baseline, week 16, 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.05  (0.41) 0.27  (0.45)
55.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)
Hide Description Change from baseline in forced vital capacity (week 16, 120 minutes)
Time Frame baseline, week 16, 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.05  (0.41) 0.26  (0.45)
56.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)
Hide Description Change from baseline in forced vital capacity (week 16, 180 minutes)
Time Frame baseline, week 16, 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: litres
-0.05  (0.42) 0.26  (0.45)
57.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)
Hide Description Change from baseline in forced vital capacity (week 24, pre-dose)
Time Frame baseline, week 24, pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
-0.14  (0.03) 0.07  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval 95%
0.14 to 0.28
Estimation Comments [Not Specified]
58.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)
Hide Description Change from baseline in forced vital capacity (week 24, 30 minutes)
Time Frame baseline, week 24, 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
-0.10  (0.03) 0.19  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms include treatment, site, and forced vital capacity at baseline

Mean Difference (Final Values) means difference in LSMeans

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.29
Confidence Interval 95%
0.21 to 0.36
Estimation Comments [Not Specified]
59.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)
Hide Description Change from baseline in forced vital capacity (week 24, 60 minutes)
Time Frame baseline, week 24, 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
-0.07  (0.03) 0.23  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval 95%
0.23 to 0.38
Estimation Comments [Not Specified]
60.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)
Hide Description Change from baseline in forced vital capacity (week 24, 120 minutes)
Time Frame baseline, week 24, 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
-0.11  (0.03) 0.22  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval 95%
0.25 to 0.40
Estimation Comments [Not Specified]
61.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)
Hide Description Change from baseline in forced vital capacity (week 24, 180 minutes)
Time Frame baseline, week 24, 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Least Squares Mean (Standard Error)
Unit of Measure: litres
-0.07  (0.04) 0.29  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms include treatment, site, and forced vital capacity at baseline

Mean Difference (Final Values) means difference in LSMeans

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.35
Confidence Interval 95%
0.26 to 0.45
Estimation Comments [Not Specified]
62.Secondary Outcome
Title Albuterol Use p.r.n. (Baseline)
Hide Description Number of days that participants used albuterol prn per week
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: days
2.1  (2.76) 1.8  (2.63)
63.Secondary Outcome
Title Change From Baseline in Albuterol Use p.r.n. - (Week 4)
Hide Description Difference in number of days that participants used albuterol prn per week between week 4 and baseline
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Mean (Standard Deviation)
Unit of Measure: days
-0.2  (1.71) -0.2  (2.07)
64.Secondary Outcome
Title Change From Baseline in Albuterol Use p.r.n. - (Week 8)
Hide Description Difference in number of days that participants used albuterol prn per week between week 8 and baseline
Time Frame baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 225
Mean (Standard Deviation)
Unit of Measure: days
-0.3  (2.13) -0.3  (1.96)
65.Secondary Outcome
Title Change From Baseline in Albuterol Use p.r.n. -(Week 12)
Hide Description Difference in number of days that participants used albuterol prn per week between week 12 and baseline
Time Frame baseline, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 206 220
Mean (Standard Deviation)
Unit of Measure: days
-0.3  (2.16) -0.3  (2.09)
66.Secondary Outcome
Title Change From Baseline in Albuterol Use p.r.n. - (Week 16)
Hide Description Difference in number of days that participants used albuterol prn per week between week 16 and baseline
Time Frame baseline, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 203 215
Mean (Standard Deviation)
Unit of Measure: days
-0.4  (2.10) -0.3  (2.26)
67.Secondary Outcome
Title Change From Baseline in Albuterol Use p.r.n. -(Week 20)
Hide Description Difference in number of days that participants used albuterol prn per week between week 20 and baseline
Time Frame baseline, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 201 212
Mean (Standard Deviation)
Unit of Measure: days
-0.4  (2.34) -0.3  (2.21)
68.Secondary Outcome
Title Change From Baseline in Albuterol Use p.r.n. - (Week 24)
Hide Description Difference in number of days that participants used albuterol prn per week between week 24 and baseline
Time Frame baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 201 216
Least Squares Mean (Standard Error)
Unit of Measure: days
-0.64  (0.18) -0.62  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.927
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms include treatment, site, and albuterol use at baseline

Mean Difference (Final Values) means difference in LSMeans

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval 95%
-0.38 to 0.41
Estimation Comments [Not Specified]
69.Secondary Outcome
Title Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)
Hide Description

The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.

Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 207 227
Measure Type: Number
Unit of Measure: Participants
Poor/Fair 62 78
Good 122 132
Excellent 23 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.174
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Site as stratum
70.Secondary Outcome
Title Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)
Hide Description

The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.

Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 204 220
Measure Type: Number
Unit of Measure: Participants
Poor/Fair 49 50
Good 135 134
Excellent 20 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.186
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Site as stratum
71.Secondary Outcome
Title Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)
Hide Description

The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.

Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 201 216
Measure Type: Number
Unit of Measure: Participants
Poor/Fair 51 41
Good 128 136
Excellent 22 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Site as stratum
72.Secondary Outcome
Title Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)
Hide Description

The patient’s global assessment was based on the subject’s need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject’s ability to exercise and perform daily activities.

Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 206 227
Measure Type: Number
Unit of Measure: Participants
Poor/Fair 72 95
Good 111 117
Excellent 23 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.223
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Site as stratum
73.Secondary Outcome
Title Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)
Hide Description

The patient’s global assessment was based on the subject’s need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject’s ability to exercise and perform daily activities.

Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 206 220
Measure Type: Number
Unit of Measure: Participants
Poor/Fair 62 53
Good 127 132
Excellent 17 35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Site as stratum
74.Secondary Outcome
Title Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)
Hide Description

The patient’s global assessment was based on the subject’s need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject’s ability to exercise and perform daily activities.

Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 201 216
Measure Type: Number
Unit of Measure: Participants
Poor/Fair 66 56
Good 116 128
Excellent 19 32
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Site as stratum
75.Secondary Outcome
Title Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)
Hide Description

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.

Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 206 227
Mean (Standard Deviation)
Unit of Measure: units on a scale
25.4  (21.43) 28  (22.32)
76.Secondary Outcome
Title Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)
Hide Description WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 205 225
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.34  (1.64) 0.98  (1.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.729
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms for treatment, site, and work productivity at baseline

Mean Difference (Final Values) means difference in LS Means

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.64
Confidence Interval 95%
-2.97 to 4.24
Estimation Comments [Not Specified]
77.Secondary Outcome
Title Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)
Hide Description WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Time Frame baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 206 225
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.12  (1.54) -0.38  (1.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.149
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms for treatment, site, and work productivity at baseline

Mean Difference (Final Values) means difference in LS Means

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.50
Confidence Interval 95%
-5.90 to 0.90
Estimation Comments [Not Specified]
78.Secondary Outcome
Title Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)
Hide Description WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Time Frame baseline, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 205 217
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.54  (1.58) -1.07  (1.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.763
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms for treatment, site, and work productivity at baseline

Mean Difference (Final Values) means difference in LSMeans

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.53
Confidence Interval 95%
-4.00 to 2.93
Estimation Comments [Not Specified]
79.Secondary Outcome
Title Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)
Hide Description WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Time Frame baseline, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 200 214
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.47  (1.64) 2.62  (1.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.313
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms for treatment, site, and work productivity at baseline

Mean Difference (Final Values) means difference in LS Means

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.85
Confidence Interval 95%
-5.45 to 1.75
Estimation Comments [Not Specified]
80.Secondary Outcome
Title Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)
Hide Description WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Time Frame baseline, week 20
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Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
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Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 200 211
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.32  (1.62) 3.52  (1.70)
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Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.682
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms for treatment, site, and work productivity at baseline

Mean Difference (Final Values) means difference in LS Means

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.79
Confidence Interval 95%
-4.60 to 3.01
Estimation Comments [Not Specified]
81.Secondary Outcome
Title Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)
Hide Description WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Time Frame baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
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Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 198 215
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.26  (1.64) 1.51  (1.54)
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Statistical Analysis Overview Comparison Group Selection Placebo, Tiotropium
Comments tiotropium versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.
Method ANCOVA
Comments

terms for treatment, site, and work productivity at baseline

Mean Difference (Final Values) means difference in LS Means

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.76
Confidence Interval 95%
-7.39 to -0.13
Estimation Comments [Not Specified]
82.Secondary Outcome
Title Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health
Hide Description

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.

Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 75 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.2  (20.24) 21.1  (21.08)
83.Secondary Outcome
Title Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)
Hide Description WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Arm/Group Title Placebo Tiotropium
Hide Arm/Group Description:
Placebo matching tiotropium via HandiHaler® + PRN albuterol
18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Number of Participants Analyzed 69 83
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.03  (2.21) -2.64  (2.03)
Show Statistical Analysis 1