Trial Outcomes & Findings for A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients. (NCT NCT00359788)

NCT ID: NCT00359788

Last Updated: 2014-05-16

Results Overview

Trough FEV1 is measured 10 minutes before drug administration

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 349 participants
• Primary outcome timeframe: Baseline and 12 Weeks
• Results posted on: 2014-05-16

Participant Flow

Participant milestones

Measure	Tiotropium 18 mcg once daily	Combivent (Ipratropium/Albuterol) 2 actuations 4 times daily
Overall Study STARTED	173	176
Overall Study COMPLETED	150	159
Overall Study NOT COMPLETED	23	17

Reasons for withdrawal

Measure	Tiotropium 18 mcg once daily	Combivent (Ipratropium/Albuterol) 2 actuations 4 times daily
Overall Study Adverse Event	11	10
Overall Study Lack of Efficacy	1	2
Overall Study Lost to Follow-up	3	2
Overall Study Withdrawal by Subject	4	1
Overall Study Protocol Violation	4	2

Baseline Characteristics

A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.

Baseline characteristics by cohort

Measure	Tiotropium n=173 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=176 Participants 2 actuations 4 times daily	Total n=349 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 7.7 • n=5 Participants	65.4 years STANDARD_DEVIATION 8 • n=7 Participants	65.1 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	13 Participants n=7 Participants	33.0 Participants n=5 Participants
Sex: Female, Male Male	153 Participants n=5 Participants	163 Participants n=7 Participants	316.0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 Weeks

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Trough FEV1 is measured 10 minutes before drug administration

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks	0.081 Liters Standard Error 0.018	-0.025 Liters Standard Error 0.018

PRIMARY outcome

Timeframe: Baseline and 12 Weeks

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Average hourly FEV1 AUC0-6 minus baseline FEV1

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks	0.187 Liters Standard Error 0.019	0.167 Liters Standard Error 0.018

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Trough FEV1 is measured 10 minutes before drug administration

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks	0.11 Liters Standard Error 0.017	-0.036 Liters Standard Error 0.017

SECONDARY outcome

Timeframe: Day 1 (after first dose)

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Average hourly FEV1 AUC0-6 minus baseline FEV1

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1	0.132 Liters Standard Error 0.012	0.211 Liters Standard Error 0.012

SECONDARY outcome

Timeframe: Baseline and week 6

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Average hourly FEV1 AUC0-6 minus baseline FEV1

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6	0.207 Liters Standard Error 0.019	0.153 Liters Standard Error 0.018

SECONDARY outcome

Timeframe: Day 1

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1	0.232 Liters Standard Error 0.014	0.364 Liters Standard Error 0.014

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6	0.204 Liters Standard Error 0.014	0.356 Liters Standard Error 0.013

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12	0.209 Liters Standard Error 0.015	0.342 Liters Standard Error 0.015

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Trough FVC is measured 10 minutes before drug administration

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks	0.225 Liters Standard Error 0.039	0.051 Liters Standard Error 0.038

SECONDARY outcome

Timeframe: Baseline and 12 Weeks

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Average hourly FVC AUC0-6 minus baseline FVC

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks	0.443 Liters Standard Error 0.037	0.432 Liters Standard Error 0.036

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Trough FVC is measured 10 minutes before drug administration

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks	0.258 Liters Standard Error 0.036	-0.02 Liters Standard Error 0.035

SECONDARY outcome

Timeframe: Day 1

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Average hourly FVC AUC0-6 minus baseline FVC

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1	0.327 Liters Standard Error 0.028	0.484 Liters Standard Error 0.028

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Average hourly FVC AUC0-6 minus baseline FVC

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks	0.464 Liters Standard Error 0.035	0.425 Liters Standard Error 0.035

SECONDARY outcome

Timeframe: Day 1

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1	0.542 Liters Standard Error 0.033	0.824 Liters Standard Error 0.032

SECONDARY outcome

Timeframe: baseline and 6 Weeks (after first dose)

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6	0.43 Liters Standard Error 0.031	0.791 Liters Standard Error 0.031

SECONDARY outcome

Timeframe: Baseline and 12 Weeks

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12	0.418 Liters Standard Error 0.032	0.703 Liters Standard Error 0.032

SECONDARY outcome

Timeframe: 15 minutes

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 15 Minutes on Day 1	1.214 Liters Standard Error 0.012	1.389 Liters Standard Error 0.011

SECONDARY outcome

Timeframe: 30 minutes

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 30 Minutes on Day 1	1.261 Liters Standard Error 0.013	1.429 Liters Standard Error 0.013

SECONDARY outcome

Timeframe: 1 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 1 Hour on Day 1	1.272 Liters Standard Error 0.014	1.455 Liters Standard Error 0.014

SECONDARY outcome

Timeframe: 2 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 2 Hours on Day 1	1.293 Least Squares Mean Standard Error 0.014	1.43 Least Squares Mean Standard Error 0.014

SECONDARY outcome

Timeframe: 3 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 3 Hours on Day 1	1.29 Liters Standard Error 0.015	1.375 Liters Standard Error 0.014

SECONDARY outcome

Timeframe: 4 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 4 Hours on Day 1	1.284 Liters Standard Error 0.015	1.319 Liters Standard Error 0.015

SECONDARY outcome

Timeframe: 6 hours

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 6 Hours on Day 1	1.269 Liters Standard Error 0.016	1.233 Liters Standard Error 0.015

SECONDARY outcome

Timeframe: 10 minutes before dosing

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at -10 Minutes at Week 6	1.254 Liters Standard Error 0.017	1.108 Liters Standard Error 0.017

SECONDARY outcome

Timeframe: 15 minutes

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 15 Minutes at Week 6	1.3 Liters Standard Error 0.019	1.355 Liters Standard Error 0.019

SECONDARY outcome

Timeframe: 30 minutes

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 30 Minutes at Week 6	1.328 Liters Standard Error 0.02	1.388 Liters Standard Error 0.02

SECONDARY outcome

Timeframe: 1 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 1 Hour at Week 6	1.343 Liters Standard Error 0.021	1.405 Liters Standard Error 0.021

SECONDARY outcome

Timeframe: 2 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 2 Hours at Week 6	1.364 Liters Standard Error 0.021	1.382 Liters Standard Error 0.02

SECONDARY outcome

Timeframe: 3 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 3 Hours at Week 6	1.371 Liters Standard Error 0.021	1.31 Liters Standard Error 0.02

SECONDARY outcome

Timeframe: 4 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 4 Hours at Week 6	1.369 Liters Standard Error 0.02	1.247 Liters Standard Error 0.02

SECONDARY outcome

Timeframe: 6 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 6 Hours at Week 6	1.33 Liters Standard Error 0.019	1.168 Liters Standard Error 0.019

SECONDARY outcome

Timeframe: 10 minutes before dosing

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at -10 Minutes at Week 12	1.225 Liters Standard Error 0.018	1.119 Liters Standard Error 0.018

SECONDARY outcome

Timeframe: 15 minutes

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 15 Minutes at Week 12	1.268 Liters Standard Error 0.019	1.351 Liters Standard Error 0.019

SECONDARY outcome

Timeframe: 30 minutes

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 30 Minutes at Week 12	1.306 Liters Standard Error 0.02	1.393 Liters Standard Error 0.019

SECONDARY outcome

Timeframe: 1 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 1 Hour at Week 12	1.327 Liters Standard Error 0.02	1.41 Liters Standard Error 0.02

SECONDARY outcome

Timeframe: 2 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 2 Hours at Week 12	1.353 Liters Standard Error 0.021	1.398 Liters Standard Error 0.02

SECONDARY outcome

Timeframe: 3 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 3 Hours at Week 12	1.353 Liters Standard Error 0.021	1.333 Liters Standard Error 0.02

SECONDARY outcome

Timeframe: 4 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 4 Hours at Week 12	1.337 Liters Standard Error 0.02	1.263 Liters Standard Error 0.019

SECONDARY outcome

Timeframe: 6 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FEV1 at 6 Hours at Week 12	1.318 Liters Standard Error 0.019	1.182 Liters Standard Error 0.019

SECONDARY outcome

Timeframe: 15 minutes

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 15 Minutes on Day 1	2.938 Liters Standard Error 0.036	3.308 Liters Standard Error 0.035

SECONDARY outcome

Timeframe: 30 minutes

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 30 Minutes on Day 1	3.044 Liters Standard Error 0.03	3.4 Liters Standard Error 0.03

SECONDARY outcome

Timeframe: 1 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 1 Hour on Day 1	3.087 Liters Standard Error 0.033	3.444 Liters Standard Error 0.033

SECONDARY outcome

Timeframe: 2 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 2 Hours on Day 1	3.103 Liters Standard Error 0.033	3.388 Liters Standard Error 0.032

SECONDARY outcome

Timeframe: 3 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 3 Hours on Day 1	3.091 Liters Standard Error 0.033	3.261 Liters Standard Error 0.032

SECONDARY outcome

Timeframe: 4 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 4 Hours on Day 1	3.087 Liters Standard Error 0.034	3.136 Liters Standard Error 0.033

SECONDARY outcome

Timeframe: 6 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 6 Hours on Day 1	3.053 Liters Standard Error 0.034	2.972 Liters Standard Error 0.034

SECONDARY outcome

Timeframe: 10 minutes before dosing

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at -10 Minutes at Week 6	3 Liters Standard Error 0.036	2.722 Liters Standard Error 0.035

SECONDARY outcome

Timeframe: 15 minutes

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 15 Minutes at Week 6	3.09 Liters Standard Error 0.037	3.279 Liters Standard Error 0.036

SECONDARY outcome

Timeframe: 30 minutes

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 30 Minutes at Week 6	3.158 Liters Standard Error 0.039	3.362 Liters Standard Error 0.039

SECONDARY outcome

Timeframe: 1 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 1 Hour at Week 6	3.206 Liters Standard Error 0.04	3.388 Liters Standard Error 0.039

SECONDARY outcome

Timeframe: 2 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 2 Hours at Week 6	3.227 Liters Standard Error 0.039	3.338 Liters Standard Error 0.038

SECONDARY outcome

Timeframe: 3 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 3 Hours at Week 6	3.235 Liters Standard Error 0.039	3.185 Liters Standard Error 0.038

SECONDARY outcome

Timeframe: 4 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 4 Hours at Week 6	3.23 Liters Standard Error 0.039	3.068 Liters Standard Error 0.038

SECONDARY outcome

Timeframe: 6 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 6 Hours at Week 6	3.190 Liters Standard Error 0.037	2.914 Liters Standard Error 0.036

SECONDARY outcome

Timeframe: 10 minutes before dosing

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at -10 Minutes at Week 12	2.967 Liters Standard Error 0.039	2.792 Liters Standard Error 0.038

SECONDARY outcome

Timeframe: 15 minutes

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 15 Minutes at Week 12	3.069 Liters Standard Error 0.037	3.263 Liters Standard Error 0.036

SECONDARY outcome

Timeframe: 30 minutes

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 30 Minutes at Week 12	3.143 Liters Standard Error 0.039	3.358 Liters Standard Error 0.038

SECONDARY outcome

Timeframe: 1 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 1 Hour at Week 12	3.177 Liters Standard Error 0.04	3.375 Liters Standard Error 0.039

SECONDARY outcome

Timeframe: 2 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 2 Hours at Week 12	3.231 Liters Standard Error 0.04	3.328 Liters Standard Error 0.04

SECONDARY outcome

Timeframe: 3 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 3 Hours at Week 12	3.226 Liters Standard Error 0.04	3.218 Liters Standard Error 0.039

SECONDARY outcome

Timeframe: 4 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 4 Hours at Week 12	3.199 Liters Standard Error 0.04	3.074 Liters Standard Error 0.039

SECONDARY outcome

Timeframe: 6 hour

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
FVC at 6 Hours at Week 12	3.155 Liters Standard Error 0.04	2.932 Liters Standard Error 0.04

SECONDARY outcome

Timeframe: Week 1

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the day in week 1

Outcome measures

Measure	Tiotropium n=151 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Day Time Albuterol Use During Week 1	1.175 Puffs per day Standard Error 0.084	1.217 Puffs per day Standard Error 0.082

SECONDARY outcome

Timeframe: Week 2

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the day in week 2

Outcome measures

Measure	Tiotropium n=151 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Day Time Albuterol Use During Week 2	1.24 Puffs per day Standard Error 0.099	1.309 Puffs per day Standard Error 0.096

SECONDARY outcome

Timeframe: Week 3

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the day in week 3

Outcome measures

Measure	Tiotropium n=151 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Day Time Albuterol Use During Week 3	1.337 Puffs per day Standard Error 0.104	1.41 Puffs per day Standard Error 0.101

SECONDARY outcome

Timeframe: Week 4

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the day in week 4

Outcome measures

Measure	Tiotropium n=151 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Day Time Albuterol Use During Week 4	1.287 Puffs per day Standard Error 0.107	1.399 Puffs per day Standard Error 0.104

SECONDARY outcome

Timeframe: Week 5

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the day in week 5

Outcome measures

Measure	Tiotropium n=151 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Day Time Albuterol Use During Week 5	1.275 Puffs per day Standard Error 0.11	1.345 Puffs per day Standard Error 0.107

SECONDARY outcome

Timeframe: Week 6

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the day in week 6

Outcome measures

Measure	Tiotropium n=151 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Day Time Albuterol Use During Week 6	1.259 Puffs per day Standard Error 0.126	1.405 Puffs per day Standard Error 0.123

SECONDARY outcome

Timeframe: Week 7

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the day in week 7

Outcome measures

Measure	Tiotropium n=151 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Day Time Albuterol Use During Week 7	1.313 Puffs per day Standard Error 0.116	1.398 Puffs per day Standard Error 0.114

SECONDARY outcome

Timeframe: Week 8

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the day in week 8

Outcome measures

Measure	Tiotropium n=151 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Day Time Albuterol Use During Week 8	1.301 Puffs per day Standard Error 0.119	1.471 Puffs per day Standard Error 0.117

SECONDARY outcome

Timeframe: Week 9

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the day in week 9

Outcome measures

Measure	Tiotropium n=151 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Day Time Albuterol Use During Week 9	1.369 Puffs per day Standard Error 0.12	1.43 Puffs per day Standard Error 0.117

SECONDARY outcome

Timeframe: Week 10

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the day in week 10

Outcome measures

Measure	Tiotropium n=151 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Day Time Albuterol Use During Week 10	1.351 Puffs per day Standard Error 0.116	1.394 Puffs per day Standard Error 0.114

SECONDARY outcome

Timeframe: Week 11

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the day in week 11

Outcome measures

Measure	Tiotropium n=151 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Day Time Albuterol Use During Week 11	1.352 Puffs per day Standard Error 0.127	1.445 Puffs per day Standard Error 0.124

SECONDARY outcome

Timeframe: Week 12

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the day in week 12

Outcome measures

Measure	Tiotropium n=151 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Day Time Albuterol Use During Week 12	1.361 Puffs per day Standard Error 0.139	1.409 Puffs per day Standard Error 0.137

SECONDARY outcome

Timeframe: Week 1

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=143 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Night Time Albuterol Use During Week 1	3.493 Puffs per night Standard Error 0.259	2.966 Puffs per night Standard Error 0.248

SECONDARY outcome

Timeframe: Week 2

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the night in week 2

Outcome measures

Measure	Tiotropium n=143 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Night Time Albuterol Use During Week 2	3.269 Puffs per night Standard Error 0.19	3.004 Puffs per night Standard Error 0.182

SECONDARY outcome

Timeframe: Week 3

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the night in week 3

Outcome measures

Measure	Tiotropium n=143 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Night Time Albuterol Use During Week 3	3.282 Puffs per night Standard Error 0.187	2.931 Puffs per night Standard Error 0.18

SECONDARY outcome

Timeframe: Week 4

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the night in week 4

Outcome measures

Measure	Tiotropium n=143 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Night Time Albuterol Use During Week 4	3.285 Puffs per night Standard Error 0.193	2.921 Puffs per night Standard Error 0.184

SECONDARY outcome

Timeframe: Week 5

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the night in week 5

Outcome measures

Measure	Tiotropium n=143 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Night Time Albuterol Use During Week 5	3.152 Puffs per night Standard Error 0.194	2.789 Puffs per night Standard Error 0.185

SECONDARY outcome

Timeframe: Week 6

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the night in week 6

Outcome measures

Measure	Tiotropium n=143 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Night Time Albuterol Use During Week 6	3.178 Puffs per night Standard Error 0.197	2.806 Puffs per night Standard Error 0.188

SECONDARY outcome

Timeframe: Week 7

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the night in week 7

Outcome measures

Measure	Tiotropium n=143 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Night Time Albuterol Use During Week 7	3.156 Puffs per night Standard Error 0.201	2.966 Puffs per night Standard Error 0.193

SECONDARY outcome

Timeframe: Week 8

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the night in week 8

Outcome measures

Measure	Tiotropium n=143 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Night Time Albuterol Use During Week 8	3.104 Puffs per night Standard Error 0.207	2.983 Puffs per night Standard Error 0.198

SECONDARY outcome

Timeframe: Week 9

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the night in week 9

Outcome measures

Measure	Tiotropium n=143 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Night Time Albuterol Use During Week 9	3.254 Puffs per night Standard Error 0.208	3.006 Puffs per night Standard Error 0.198

SECONDARY outcome

Timeframe: Week 10

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the night in week 10

Outcome measures

Measure	Tiotropium n=143 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Night Time Albuterol Use During Week 10	3.199 Puffs per night Standard Error 0.203	2.909 Puffs per night Standard Error 0.196

SECONDARY outcome

Timeframe: Week 11

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the night in week 11

Outcome measures

Measure	Tiotropium n=143 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Night Time Albuterol Use During Week 11	3.224 Puffs per night Standard Error 0.214	2.907 Puffs per night Standard Error 0.205

SECONDARY outcome

Timeframe: Week 12

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Puffs of rescue albuterol used during the night in week 12

Outcome measures

Measure	Tiotropium n=143 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Night Time Albuterol Use During Week 12	3.178 Puffs per night Standard Error 0.238	3.069 Puffs per night Standard Error 0.229

SECONDARY outcome

Timeframe: Week 1

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Outcome measures

Measure	Tiotropium n=150 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Morning Peak Expiratory Flow Rate (PEFR) at Week 1	205.8 Liters/minute Standard Error 2.1	195.1 Liters/minute Standard Error 2.059

SECONDARY outcome

Timeframe: Week 2

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for morning PEFR

Outcome measures

Measure	Tiotropium n=150 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Morning PEFR at Week 2	206.07 Liters/minute Standard Error 2.594	194.81 Liters/minute Standard Error 2.516

SECONDARY outcome

Timeframe: Week 3

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for morning PEFR

Outcome measures

Measure	Tiotropium n=150 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Morning PEFR at Week 3	206.61 Liters/minute Standard Error 2.816	193.83 Liters/minute Standard Error 2.742

SECONDARY outcome

Timeframe: Week 4

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for morning PEFR

Outcome measures

Measure	Tiotropium n=150 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Morning PEFR at Week 4	206.76 Liters/minute Standard Error 2.959	193.19 Liters/minute Standard Error 2.88

SECONDARY outcome

Timeframe: Week 5

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for morning PEFR

Outcome measures

Measure	Tiotropium n=150 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Morning PEFR at Week 5	205.6 Liters/minute Standard Error 3.012	193.55 Liters/minute Standard Error 2.932

SECONDARY outcome

Timeframe: Week 6

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for morning PEFR

Outcome measures

Measure	Tiotropium n=150 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Morning PEFR at Week 6	206.49 Liters/minute Standard Error 3.236	195.38 Liters/minute Standard Error 3.158

SECONDARY outcome

Timeframe: Week 7

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for morning PEFR

Outcome measures

Measure	Tiotropium n=150 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Morning PEFR at Week 7	208.72 Liters/minute Standard Error 3.377	197.66 Liters/minute Standard Error 3.326

SECONDARY outcome

Timeframe: Week 8

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for morning PEFR

Outcome measures

Measure	Tiotropium n=150 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Morning PEFR at Week 8	208.88 Liters/minute Standard Error 3.385	195.22 Liters/minute Standard Error 3.315

SECONDARY outcome

Timeframe: Week 9

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for morning PEFR

Outcome measures

Measure	Tiotropium n=150 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Morning PEFR at Week 9	208.97 Liters/minute Standard Error 3.621	194.74 Liters/minute Standard Error 3.531

SECONDARY outcome

Timeframe: Week 10

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for morning PEFR

Outcome measures

Measure	Tiotropium n=150 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Morning PEFR at Week 10	204.83 Liters/minute Standard Error 3.608	193.23 Liters/minute Standard Error 3.568

SECONDARY outcome

Timeframe: Week 11

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for morning PEFR

Outcome measures

Measure	Tiotropium n=150 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Morning PEFR at Week 11	206.47 Liters/minute Standard Error 3.607	195.47 Liters/minute Standard Error 3.542

SECONDARY outcome

Timeframe: Week 12

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for morning PEFR

Outcome measures

Measure	Tiotropium n=150 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Morning PEFR at Week 12	206.52 Liters/minute Standard Error 4.408	192.44 Liters/minute Standard Error 3.996

SECONDARY outcome

Timeframe: Week 1

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for evening PEFR

Outcome measures

Measure	Tiotropium n=142 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Evening PEFR at Week 1	222.89 Liters/minute Standard Error 2.459	222.64 Liters/minute Standard Error 2.352

SECONDARY outcome

Timeframe: Week 2

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for evening PEFR

Outcome measures

Measure	Tiotropium n=142 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Evening PEFR at Week 2	221.97 Liters/minute Standard Error 2.715	221.12 Liters/minute Standard Error 2.596

SECONDARY outcome

Timeframe: Week 3

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for evening PEFR

Outcome measures

Measure	Tiotropium n=142 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Evening PEFR at Week 3	221.23 Liters/minute Standard Error 2.793	218.52 Liters/minute Standard Error 2.681

SECONDARY outcome

Timeframe: Week 4

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for evening PEFR

Outcome measures

Measure	Tiotropium n=142 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Evening PEFR at Week 4	221.96 Liters/minute Standard Error 2.933	215.06 Liters/minute Standard Error 2.796

SECONDARY outcome

Timeframe: Week 5

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for evening PEFR

Outcome measures

Measure	Tiotropium n=142 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Evening PEFR at Week 5	217.95 Liters/minute Standard Error 3.125	214.53 Liters/minute Standard Error 2.977

SECONDARY outcome

Timeframe: Week 6

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for evening PEFR

Outcome measures

Measure	Tiotropium n=142 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Evening PEFR at Week 6	218.45 Liters/minute Standard Error 3.535	219.42 Liters/minute Standard Error 3.382

SECONDARY outcome

Timeframe: Week 7

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for evening PEFR

Outcome measures

Measure	Tiotropium n=142 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Evening PEFR at Week 7	220.98 Liters/minute Standard Error 3.63	220.79 Liters/minute Standard Error 3.468

SECONDARY outcome

Timeframe: Week 8

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for evening PEFR

Outcome measures

Measure	Tiotropium n=142 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Evening PEFR at Week 8	223.33 Liters/minute Standard Error 3.721	218.2 Liters/minute Standard Error 3.553

SECONDARY outcome

Timeframe: Week 9

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for evening PEFR

Outcome measures

Measure	Tiotropium n=142 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Evening PEFR at Week 9	221.47 Liters/minute Standard Error 3.86	217.41 Liters/minute Standard Error 3.674

SECONDARY outcome

Timeframe: Week 10

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for evening PEFR

Outcome measures

Measure	Tiotropium n=142 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Evening PEFR at Week 10	220.46 Liters/minute Standard Error 3.808	216.32 Liters/minute Standard Error 3.649

SECONDARY outcome

Timeframe: Week 11

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for evening PEFR

Outcome measures

Measure	Tiotropium n=142 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Evening PEFR at Week 11	218.35 Liters/minute Standard Error 3.91	217.17 Liters/minute Standard Error 3.724

SECONDARY outcome

Timeframe: Week 12

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

Weekly means for evening PEFR

Outcome measures

Measure	Tiotropium n=142 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=157 Participants 2 actuations 4 times daily
Evening PEFR at Week 12	219.66 Liters/minute Standard Error 4.371	215.46 Liters/minute Standard Error 4.19

SECONDARY outcome

Timeframe: Week 6

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to chronic obstructive pulmonary disease (COPD). The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8)

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Patient Global Evaluation	4.273 Units on a scale Standard Error 0.081	4.069 Units on a scale Standard Error 0.079

SECONDARY outcome

Timeframe: Week 12

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Patient Global Evaluation	4.49 Units on a scale Standard Error 0.1	4.239 Units on a scale Standard Error 0.098

SECONDARY outcome

Timeframe: Week 6

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Physician Global Evaluation	4.867 Units on a scale Standard Error 0.076	4.716 Units on a scale Standard Error 0.075

SECONDARY outcome

Timeframe: Week 12

Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.

The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).

Outcome measures

Measure	Tiotropium n=152 Participants 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=158 Participants 2 actuations 4 times daily
Physician Global Evaluation	5.057 Units on a scale Standard Error 0.076	4.772 Units on a scale Standard Error 0.074

Adverse Events

Tiotropium

Serious events: 11 serious events

Other events: 11 other events

Deaths: 0 deaths

Combivent (Ipratropium/Albuterol)

Serious events: 12 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tiotropium n=173 participants at risk 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=176 participants at risk 2 actuations 4 times daily
Cardiac disorders Atrial Flutter	0.00% 0/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
Cardiac disorders Cardiac failure congestive	0.00% 0/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
Gastrointestinal disorders Gastroesophageal Reflux disease	0.00% 0/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
Gastrointestinal disorders Ileus	0.00% 0/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
Gastrointestinal disorders Small intestional obstruction	0.00% 0/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
General disorders Death	1.2% 2/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
Infections and infestations Appendicitis	0.00% 0/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
Infections and infestations Cellulitis	0.58% 1/173 • From first drug administration until 30 days after last drug adminsitration	0.00% 0/176 • From first drug administration until 30 days after last drug adminsitration
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.58% 1/173 • From first drug administration until 30 days after last drug adminsitration	0.00% 0/176 • From first drug administration until 30 days after last drug adminsitration
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.58% 1/173 • From first drug administration until 30 days after last drug adminsitration	0.00% 0/176 • From first drug administration until 30 days after last drug adminsitration
Nervous system disorders Convulsion	0.58% 1/173 • From first drug administration until 30 days after last drug adminsitration	0.00% 0/176 • From first drug administration until 30 days after last drug adminsitration
Psychiatric disorders Completed suicide	0.00% 0/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.7% 3/173 • From first drug administration until 30 days after last drug adminsitration	2.3% 4/176 • From first drug administration until 30 days after last drug adminsitration
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.58% 1/173 • From first drug administration until 30 days after last drug adminsitration	0.00% 0/176 • From first drug administration until 30 days after last drug adminsitration
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage unspecified	0.00% 0/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
Infections and infestations Lobar pneumonia	0.00% 0/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration
Infections and infestations Pneumonia	0.58% 1/173 • From first drug administration until 30 days after last drug adminsitration	0.57% 1/176 • From first drug administration until 30 days after last drug adminsitration

Other adverse events

Measure	Tiotropium n=173 participants at risk 18 mcg once daily	Combivent (Ipratropium/Albuterol) n=176 participants at risk 2 actuations 4 times daily
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	6.4% 11/173 • From first drug administration until 30 days after last drug adminsitration	5.1% 9/176 • From first drug administration until 30 days after last drug adminsitration

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
• Publication restrictions are in place

Restriction type: OTHER