Trial Outcomes & Findings for Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD). (NCT NCT00523991)

NCT ID: NCT00523991

Last Updated: 2014-05-20

Results Overview

Change = Week 24 Value - Baseline Value

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

457 participants

Primary outcome timeframe

baseline, week 24

Results posted on

2014-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo matching tiotropium via HandiHaler® + Pro Re Nata (PRN) albuterol	Tiotropium 18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Study STARTED	219	238
Overall Study COMPLETED	198	211
Overall Study NOT COMPLETED	21	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo matching tiotropium via HandiHaler® + Pro Re Nata (PRN) albuterol	Tiotropium 18 mcg tiotropium via HandiHaler® + PRN albuterol
Overall Study Adverse Event	6	5
Overall Study Protocol Violation	1	4
Overall Study Lost to Follow-up	4	1
Overall Study Withdrawal by Subject	7	17
Overall Study Other reason (not specified)	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=219 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol	Tiotropium n=238 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Total n=457 Participants Total of all reporting groups
Age, Continuous	62.3 years STANDARD_DEVIATION 8.6 • n=93 Participants	61.2 years STANDARD_DEVIATION 8.2 • n=4 Participants	61.7 years STANDARD_DEVIATION 8.4 • n=27 Participants
Age, Customized 18-44 years	8 participants n=93 Participants	7 participants n=4 Participants	15 participants n=27 Participants
Age, Customized 45-64 years	121 participants n=93 Participants	151 participants n=4 Participants	272 participants n=27 Participants
Age, Customized >=65 years	90 participants n=93 Participants	80 participants n=4 Participants	170 participants n=27 Participants
Sex: Female, Male Female	72 Participants n=93 Participants	72 Participants n=4 Participants	144 Participants n=27 Participants
Sex: Female, Male Male	147 Participants n=93 Participants	166 Participants n=4 Participants	313 Participants n=27 Participants
Race/Ethnicity, Customized Black	6 participants n=93 Participants	4 participants n=4 Participants	10 participants n=27 Participants
Race/Ethnicity, Customized White	213 participants n=93 Participants	234 participants n=4 Participants	447 participants n=27 Participants

PRIMARY outcome

Timeframe: baseline, week 24

Population: 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

Change = Week 24 Value - Baseline Value

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
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)	0.16 litres * hours Standard Error 0.02	-0.06 litres * hours Standard Error 0.02

SECONDARY outcome

Timeframe: Baseline

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)	1.74 litres Standard Deviation 0.46	1.71 litres Standard Deviation 0.45

SECONDARY outcome

Timeframe: Baseline, week 8

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)	0.12 litres Standard Deviation 0.21	-0.03 litres Standard Deviation 0.21

SECONDARY outcome

Timeframe: Baseline, week 16

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)	0.09 litres Standard Deviation 0.27	-0.06 litres Standard Deviation 0.21

SECONDARY outcome

Timeframe: Baseline, week 24

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)	0.06 litres Standard Error 0.02	-0.08 litres Standard Error 0.02

SECONDARY outcome

Timeframe: Baseline

Population: 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

Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Peak Forced Expiratory Volume in 1 Second (Baseline)	1.74 litres Standard Deviation 0.46	1.71 litres Standard Deviation 0.45

SECONDARY outcome

Timeframe: Baseline, week 8

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)	0.31 litres Standard Deviation 0.24	0.09 litres Standard Deviation 0.22

SECONDARY outcome

Timeframe: Baseline, week 16

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)	0.29 litres Standard Deviation 0.28	0.05 litres Standard Deviation 0.24

SECONDARY outcome

Timeframe: Baseline, week 24

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)	0.26 litres Standard Error 0.02	0.02 litres Standard Error 0.02

SECONDARY outcome

Timeframe: Baseline

Population: 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

Forced expiratory volume in 1 second (baseline, pre-dose)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)	1.74 litres Standard Deviation 0.46	1.71 litres Standard Deviation 0.45

SECONDARY outcome

Timeframe: baseline, 30 minutes

Population: 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

Forced expiratory volume in 1 second (baseline, 30 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)	1.87 litres Standard Deviation 0.47	1.73 litres Standard Deviation 0.45

SECONDARY outcome

Timeframe: baseline, 60 minutes

Population: 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

Forced expiratory volume in 1 second (baseline, 60 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)	1.90 litres Standard Deviation 0.47	1.74 litres Standard Deviation 0.47

SECONDARY outcome

Timeframe: Baseline, 120 minutes

Population: 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

Forced expiratory volume in 1 second (baseline, 120 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)	1.92 litres Standard Deviation 0.49	1.75 litres Standard Deviation 0.48

SECONDARY outcome

Timeframe: Baseline, 180 minutes

Population: 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

Forced expiratory volume in 1 second (baseline, 180 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)	1.94 litres Standard Deviation 0.48	1.76 litres Standard Deviation 0.48

SECONDARY outcome

Timeframe: baseline, week 8, pre-dose

Population: 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

Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)	0.12 litres Standard Deviation 0.21	-0.03 litres Standard Deviation 0.21

SECONDARY outcome

Timeframe: Baseline, week 8, 30 minutes

Population: 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

Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)	0.20 litres Standard Deviation 0.22	0.00 litres Standard Deviation 0.22

SECONDARY outcome

Timeframe: baseline, week 8, 60 minutes

Population: 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

Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)	0.22 litres Standard Deviation 0.24	0.01 litres Standard Deviation 0.24

SECONDARY outcome

Timeframe: baseline, week 8, 120 minutes

Population: 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

Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)	0.24 litres Standard Deviation 0.23	0.01 litres Standard Deviation 0.23

SECONDARY outcome

Timeframe: baseline, week 8, 180 minutes

Population: 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

Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)	0.24 litres Standard Deviation 0.25	0.01 litres Standard Deviation 0.22

SECONDARY outcome

Timeframe: baseline, week 16, pre-dose

Population: 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

Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)	0.09 litres Standard Deviation 0.27	-0.06 litres Standard Deviation 0.21

SECONDARY outcome

Timeframe: Baseline, week 16, 30 minutes

Population: 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

Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)	0.19 litres Standard Deviation 0.27	-0.02 litres Standard Deviation 0.24

SECONDARY outcome

Timeframe: baseline, week 16, 60 minutes

Population: 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

Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)	0.21 litres Standard Deviation 0.27	-0.02 litres Standard Deviation 0.24

SECONDARY outcome

Timeframe: baseline, week 16, 120 minutes

Population: 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

Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)	0.22 litres Standard Deviation 0.28	-0.03 litres Standard Deviation 0.24

SECONDARY outcome

Timeframe: baseline, week 16, 180 minutes

Population: 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

Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)	0.22 litres Standard Deviation 0.28	-0.02 litres Standard Deviation 0.24

SECONDARY outcome

Timeframe: baseline, week 24, pre-dose

Population: 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

Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)	0.06 litres Standard Error 0.02	-0.08 litres Standard Error 0.02

SECONDARY outcome

Timeframe: baseline, week 24, 30 minutes

Population: 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

Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)	0.15 litres Standard Error 0.02	-0.05 litres Standard Error 0.02

SECONDARY outcome

Timeframe: baseline, week 24, 60 minutes

Population: 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

Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)	0.18 litres Standard Error 0.02	-0.05 litres Standard Error 0.02

SECONDARY outcome

Timeframe: baseline, week 24, 120 minutes

Population: 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

Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)	0.18 litres Standard Error 0.02	-0.06 litres Standard Error 0.02

SECONDARY outcome

Timeframe: baseline, week 24, 180 minutes

Population: 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

Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)	0.20 litres Standard Error 0.02	-0.05 litres Standard Error 0.02

SECONDARY outcome

Timeframe: baseline

Population: 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

Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
FVC AUC0-3 at Baseline	3.24 litres * hours Standard Deviation 0.81	3.17 litres * hours Standard Deviation 0.82

SECONDARY outcome

Timeframe: baseline, week 8

Population: 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

Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
FVC AUC0-3 at Week 8 Minus Baseline	0.28 litres * hours Standard Deviation 0.39	-0.01 litres * hours Standard Deviation 0.35

SECONDARY outcome

Timeframe: baseline, week 16

Population: 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

Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
FVC AUC0-3 at Week 16 Minus Baseline	0.24 litres * hours Standard Deviation 0.43	-0.06 litres * hours Standard Deviation 0.39

SECONDARY outcome

Timeframe: baseline, week 24

Population: 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

Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
FVC AUC0-3 at Week 24 Minus Baseline	0.19 litres * hours Standard Error 0.03	-0.11 litres * hours Standard Error 0.03

SECONDARY outcome

Timeframe: baseline

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Trough Forced Vital Capacity (Baseline)	3.24 litres Standard Deviation 0.81	3.17 litres Standard Deviation 0.82

SECONDARY outcome

Timeframe: baseline, week 8

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Trough Forced Vital Capacity (at Week 8)	0.16 litres Standard Deviation 0.38	-0.06 litres Standard Deviation 0.33

SECONDARY outcome

Timeframe: baseline, week 16

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Trough Forced Vital Capacity (at Week 16)	0.10 litres Standard Deviation 0.42	-0.13 litres Standard Deviation 0.37

SECONDARY outcome

Timeframe: baseline, week 24

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Trough Forced Vital Capacity (at Week 24)	0.07 litres Standard Error 0.03	-0.14 litres Standard Error 0.03

SECONDARY outcome

Timeframe: baseline

Population: 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

Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Peak Forced Vital Capacity (FVC) (Baseline)	3.24 litres Standard Deviation 0.81	3.17 litres Standard Deviation 0.82

SECONDARY outcome

Timeframe: baseline, week 8

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Vital Capacity (at Week 8)	0.43 litres Standard Deviation 0.40	0.13 litres Standard Deviation 0.34

SECONDARY outcome

Timeframe: baseline, week 16

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Vital Capacity (at Week 16)	0.38 litres Standard Deviation 0.44	0.08 litres Standard Deviation 0.40

SECONDARY outcome

Timeframe: baseline, week 24

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Peak Forced Vital Capacity (at Week 24)	0.40 litres Standard Error 0.04	0.06 litres Standard Error 0.04

SECONDARY outcome

Timeframe: baseline

Population: 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

Forced vital capacity (baseline, pre-dose)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Forced Vital Capacity (Baseline, Pre-dose)	3.24 litres Standard Deviation 0.81	3.17 litres Standard Deviation 0.82

SECONDARY outcome

Timeframe: baseline, 30 minutes

Population: 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

Forced vital capacity (baseline, 30 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Forced Vital Capacity (Baseline, 30 Minutes)	3.45 litres Standard Deviation 0.83	3.20 litres Standard Deviation 0.82

SECONDARY outcome

Timeframe: baseline, 60 minutes

Population: 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

Forced vital capacity (baseline, 60 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Forced Vital Capacity (Baseline, 60 Minutes)	3.48 litres Standard Deviation 0.84	3.22 litres Standard Deviation 0.85

SECONDARY outcome

Timeframe: baseline, 120 minutes

Population: 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

Forced vital capacity (baseline, 120 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Forced Vital Capacity (Baseline, 120 Minutes)	3.49 litres Standard Deviation 0.85	3.21 litres Standard Deviation 0.86

SECONDARY outcome

Timeframe: baseline, 180 minutes

Population: 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

Forced vital capacity (baseline, 180 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Forced Vital Capacity (Baseline, 180 Minutes)	3.50 litres Standard Deviation 0.85	3.21 litres Standard Deviation 0.83

SECONDARY outcome

Timeframe: baseline, week 8, pre-dose

Population: 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

Change from baseline in forced vital capacity (week 8, pre-dose)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)	0.16 litres Standard Deviation 0.38	-0.06 litres Standard Deviation 0.33

SECONDARY outcome

Timeframe: baseline, week 8, 30 minutes

Population: 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

Change from baseline in forced vital capacity (week 8, 30 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)	0.27 litres Standard Deviation 0.40	0.00 litres Standard Deviation 0.35

SECONDARY outcome

Timeframe: baseline, week 8, 60 minutes

Population: 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

Change from baseline in forced vital capacity (week 8, 60 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)	0.29 litres Standard Deviation 0.43	0.00 litres Standard Deviation 0.37

SECONDARY outcome

Timeframe: baseline, week 8, 120 minutes

Population: 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

Change from baseline in forced vital capacity (week 8, 120 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)	0.30 litres Standard Deviation 0.40	-0.02 litres Standard Deviation 0.39

SECONDARY outcome

Timeframe: baseline, week 8, 180 minutes

Population: 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

Change from baseline in forced vital capacity (week 8, 180 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)	0.30 litres Standard Deviation 0.43	0.00 litres Standard Deviation 0.37

SECONDARY outcome

Timeframe: baseline, week 16, pre-dose

Population: 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

Change from baseline in forced vital capacity (week 16, pre-dose)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)	0.10 litres Standard Deviation 0.42	-0.13 litres Standard Deviation 0.37

SECONDARY outcome

Timeframe: baseline, week 16, 30 minutes

Population: 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

Change from baseline in forced vital capacity (week 16, 30 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)	0.24 litres Standard Deviation 0.45	-0.06 litres Standard Deviation 0.39

SECONDARY outcome

Timeframe: baseline, week 16, 60 minutes

Population: 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

Change from baseline in forced vital capacity (week 16, 60 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)	0.27 litres Standard Deviation 0.45	-0.05 litres Standard Deviation 0.41

SECONDARY outcome

Timeframe: baseline, week 16, 120 minutes

Population: 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

Change from baseline in forced vital capacity (week 16, 120 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)	0.26 litres Standard Deviation 0.45	-0.05 litres Standard Deviation 0.41

SECONDARY outcome

Timeframe: baseline, week 16, 180 minutes

Population: 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

Change from baseline in forced vital capacity (week 16, 180 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)	0.26 litres Standard Deviation 0.45	-0.05 litres Standard Deviation 0.42

SECONDARY outcome

Timeframe: baseline, week 24, pre-dose

Population: 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

Change from baseline in forced vital capacity (week 24, pre-dose)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)	0.07 litres Standard Error 0.03	-0.14 litres Standard Error 0.03

SECONDARY outcome

Timeframe: baseline, week 24, 30 minutes

Population: 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

Change from baseline in forced vital capacity (week 24, 30 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)	0.19 litres Standard Error 0.03	-0.10 litres Standard Error 0.03

SECONDARY outcome

Timeframe: baseline, week 24, 60 minutes

Population: 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

Change from baseline in forced vital capacity (week 24, 60 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)	0.23 litres Standard Error 0.03	-0.07 litres Standard Error 0.03

SECONDARY outcome

Timeframe: baseline, week 24, 120 minutes

Population: 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

Change from baseline in forced vital capacity (week 24, 120 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)	0.22 litres Standard Error 0.03	-0.11 litres Standard Error 0.03

SECONDARY outcome

Timeframe: baseline, week 24, 180 minutes

Population: 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

Change from baseline in forced vital capacity (week 24, 180 minutes)

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)	0.29 litres Standard Error 0.04	-0.07 litres Standard Error 0.04

SECONDARY outcome

Timeframe: baseline

Population: 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

Number of days that participants used albuterol prn per week

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Albuterol Use p.r.n. (Baseline)	1.8 days Standard Deviation 2.63	2.1 days Standard Deviation 2.76

SECONDARY outcome

Timeframe: baseline, week 4

Population: 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

Difference in number of days that participants used albuterol prn per week between week 4 and baseline

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Albuterol Use p.r.n. - (Week 4)	-0.2 days Standard Deviation 2.07	-0.2 days Standard Deviation 1.71

SECONDARY outcome

Timeframe: baseline, week 8

Population: 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

Difference in number of days that participants used albuterol prn per week between week 8 and baseline

Outcome measures

Outcome measures
Measure	Tiotropium n=225 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Albuterol Use p.r.n. - (Week 8)	-0.3 days Standard Deviation 1.96	-0.3 days Standard Deviation 2.13

SECONDARY outcome

Timeframe: baseline, week 12

Population: 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

Difference in number of days that participants used albuterol prn per week between week 12 and baseline

Outcome measures

Outcome measures
Measure	Tiotropium n=220 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=206 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Albuterol Use p.r.n. -(Week 12)	-0.3 days Standard Deviation 2.09	-0.3 days Standard Deviation 2.16

SECONDARY outcome

Timeframe: baseline, week 16

Population: 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

Difference in number of days that participants used albuterol prn per week between week 16 and baseline

Outcome measures

Outcome measures
Measure	Tiotropium n=215 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=203 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Albuterol Use p.r.n. - (Week 16)	-0.3 days Standard Deviation 2.26	-0.4 days Standard Deviation 2.10

SECONDARY outcome

Timeframe: baseline, week 20

Population: 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

Difference in number of days that participants used albuterol prn per week between week 20 and baseline

Outcome measures

Outcome measures
Measure	Tiotropium n=212 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=201 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Albuterol Use p.r.n. -(Week 20)	-0.3 days Standard Deviation 2.21	-0.4 days Standard Deviation 2.34

SECONDARY outcome

Timeframe: baseline, week 24

Population: 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

Difference in number of days that participants used albuterol prn per week between week 24 and baseline

Outcome measures

Outcome measures
Measure	Tiotropium n=216 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=201 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Albuterol Use p.r.n. - (Week 24)	-0.62 days Standard Error 0.17	-0.64 days Standard Error 0.18

SECONDARY outcome

Timeframe: baseline

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=207 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) Poor/Fair	78 Participants	62 Participants
Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) Good	132 Participants	122 Participants
Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) Excellent	17 Participants	23 Participants

SECONDARY outcome

Timeframe: week 12

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=220 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=204 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) Poor/Fair	50 Participants	49 Participants
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) Good	134 Participants	135 Participants
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) Excellent	36 Participants	20 Participants

SECONDARY outcome

Timeframe: week 24

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=216 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=201 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) Good	136 Participants	128 Participants
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) Poor/Fair	41 Participants	51 Participants
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) Excellent	39 Participants	22 Participants

SECONDARY outcome

Timeframe: baseline

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=206 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) Poor/Fair	95 Participants	72 Participants
Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) Good	117 Participants	111 Participants
Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) Excellent	15 Participants	23 Participants

SECONDARY outcome

Timeframe: week 12

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=220 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=206 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) Poor/Fair	53 Participants	62 Participants
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) Good	132 Participants	127 Participants
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) Excellent	35 Participants	17 Participants

SECONDARY outcome

Timeframe: week 24

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=216 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=201 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) Poor/Fair	56 Participants	66 Participants
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) Good	128 Participants	116 Participants
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) Excellent	32 Participants	19 Participants

SECONDARY outcome

Timeframe: baseline

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=227 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=206 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)	28 units on a scale Standard Deviation 22.32	25.4 units on a scale Standard Deviation 21.43

SECONDARY outcome

Timeframe: baseline, week 4

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=225 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=205 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)	0.98 units on a scale Standard Error 1.53	0.34 units on a scale Standard Error 1.64

SECONDARY outcome

Timeframe: baseline, week 8

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=225 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=206 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)	-0.38 units on a scale Standard Error 1.44	2.12 units on a scale Standard Error 1.54

SECONDARY outcome

Timeframe: baseline, week 12

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=217 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=205 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)	-1.07 units on a scale Standard Error 1.51	-0.54 units on a scale Standard Error 1.58

SECONDARY outcome

Timeframe: baseline, week 16

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=214 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=200 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)	2.62 units on a scale Standard Error 1.54	4.47 units on a scale Standard Error 1.64

SECONDARY outcome

Timeframe: baseline, week 20

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=211 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=200 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)	3.52 units on a scale Standard Error 1.70	4.32 units on a scale Standard Error 1.62

SECONDARY outcome

Timeframe: baseline, week 24

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=215 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=198 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)	1.51 units on a scale Standard Error 1.54	5.26 units on a scale Standard Error 1.64

SECONDARY outcome

Timeframe: baseline

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=89 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=75 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health	21.1 units on a scale Standard Deviation 21.08	17.2 units on a scale Standard Deviation 20.24

SECONDARY outcome

Timeframe: baseline, week 4

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=83 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=69 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
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)	-2.64 units on a scale Standard Error 2.03	-2.03 units on a scale Standard Error 2.21

SECONDARY outcome

Timeframe: baseline, week 8

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=77 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=68 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)	-0.61 units on a scale Standard Error 2.60	0.41 units on a scale Standard Error 2.71

SECONDARY outcome

Timeframe: baseline, week 12

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=76 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=68 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)	0.46 units on a scale Standard Error 1.84	-0.32 units on a scale Standard Error 1.91

SECONDARY outcome

Timeframe: baseline, week 16

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=74 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=67 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)	3.66 units on a scale Standard Error 2.33	3.68 units on a scale Standard Error 2.46

SECONDARY outcome

Timeframe: baseline, week 20

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=73 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=66 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)	3.08 units on a scale Standard Error 2.44	4.27 units on a scale Standard Error 2.55

SECONDARY outcome

Timeframe: baseline, week 24

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=71 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=64 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)	-1.84 units on a scale Standard Error 2.29	4.04 units on a scale Standard Error 2.43

SECONDARY outcome

Timeframe: baseline

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=89 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=74 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)	22.0 units on a scale Standard Deviation 22.06	19.3 units on a scale Standard Deviation 22.17

SECONDARY outcome

Timeframe: baseline, week 4

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=83 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=69 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)	-3.50 units on a scale Standard Error 2.31	-2.39 units on a scale Standard Error 2.48

SECONDARY outcome

Timeframe: baseline, week 8

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=77 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=68 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)	-1.04 units on a scale Standard Error 2.86	-0.62 units on a scale Standard Error 2.96

SECONDARY outcome

Timeframe: baseline, week 12

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=76 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=68 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)	4.11 units on a scale Standard Error 2.02	0.32 units on a scale Standard Error 2.09

SECONDARY outcome

Timeframe: baseline, week 16

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=74 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=67 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)	4.79 units on a scale Standard Error 2.64	2.20 units on a scale Standard Error 2.78

SECONDARY outcome

Timeframe: baseline, week 20

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=73 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=66 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)	4.10 units on a scale Standard Error 2.50	3.93 units on a scale Standard Error 2.58

SECONDARY outcome

Timeframe: baseline, week 24

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=71 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=63 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)	-2.70 units on a scale Standard Error 2.50	2.20 units on a scale Standard Error 2.70

SECONDARY outcome

Timeframe: baseline

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=94 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=76 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)	2.7 units on a scale Standard Deviation 12.35	5.5 units on a scale Standard Deviation 19.31

SECONDARY outcome

Timeframe: baseline, week 4

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=88 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=71 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)	-0.15 units on a scale Standard Error 1.77	-1.89 units on a scale Standard Error 1.96

SECONDARY outcome

Timeframe: baseline, week 8

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=84 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=71 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)	3.85 units on a scale Standard Error 2.43	-1.94 units on a scale Standard Error 2.62

SECONDARY outcome

Timeframe: baseline, week 12

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=80 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=71 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)	4.22 units on a scale Standard Error 1.55	0.12 units on a scale Standard Error 1.63

SECONDARY outcome

Timeframe: baseline, week 16

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=80 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=71 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)	0.04 units on a scale Standard Error 1.40	-3.39 units on a scale Standard Error 1.49

SECONDARY outcome

Timeframe: baseline, week 20

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=78 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=69 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)	2.00 units on a scale Standard Error 1.08	0.51 units on a scale Standard Error 1.13

SECONDARY outcome

Timeframe: baseline, week 24

Population: 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

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.

Outcome measures

Outcome measures
Measure	Tiotropium n=76 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=68 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)	-1.37 units on a scale Standard Error 1.86	0.96 units on a scale Standard Error 2.00

SECONDARY outcome

Timeframe: baseline

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Light intensity is less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm.

Outcome measures

Outcome measures
Measure	Tiotropium n=203 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=184 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day	6.8 ln(minutes) Standard Deviation 0.27	6.9 ln(minutes) Standard Deviation 0.24

SECONDARY outcome

Timeframe: baseline, week 4

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm

Outcome measures

Outcome measures
Measure	Tiotropium n=188 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=175 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day	0.02 ln(minutes) Standard Error 0.01	0.03 ln(minutes) Standard Error 0.01

SECONDARY outcome

Timeframe: baseline, week 8

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm

Outcome measures

Outcome measures
Measure	Tiotropium n=184 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=175 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day	0.03 ln(minutes) Standard Error 0.01	0.02 ln(minutes) Standard Error 0.01

SECONDARY outcome

Timeframe: baseline, week 12

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Light intensity defined as less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm

Outcome measures

Outcome measures
Measure	Tiotropium n=185 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=173 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day	0.02 ln(minutes) Standard Error 0.01	0.03 ln(minutes) Standard Error 0.01

SECONDARY outcome

Timeframe: baseline, week 16

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm

Outcome measures

Outcome measures
Measure	Tiotropium n=183 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=171 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day	0.04 ln(minutes) Standard Error 0.01	0.03 ln(minutes) Standard Error 0.01

SECONDARY outcome

Timeframe: baseline, week 20

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm

Outcome measures

Outcome measures
Measure	Tiotropium n=182 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=172 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day	0.04 ln(minutes) Standard Error 0.01	0.03 ln(minutes) Standard Error 0.01

SECONDARY outcome

Timeframe: baseline, week 24

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm

Outcome measures

Outcome measures
Measure	Tiotropium n=186 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=167 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day	0.03 ln(minutes) Standard Error 0.01	0.02 ln(minutes) Standard Error 0.02

SECONDARY outcome

Timeframe: baseline

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm

Outcome measures

Outcome measures
Measure	Tiotropium n=203 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=184 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day	4.3 ln(minutes) Standard Deviation 0.92	4.2 ln(minutes) Standard Deviation 0.96

SECONDARY outcome

Timeframe: baseline, week 4

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm

Outcome measures

Outcome measures
Measure	Tiotropium n=187 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=174 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day	-0.12 ln(minutes) Standard Error 0.05	-0.06 ln(minutes) Standard Error 0.06

SECONDARY outcome

Timeframe: baseline, week 8

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm

Outcome measures

Outcome measures
Measure	Tiotropium n=184 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=175 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day	-0.06 ln(minutes) Standard Error 0.05	0.01 ln(minutes) Standard Error 0.05

SECONDARY outcome

Timeframe: baseline, week 12

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm

Outcome measures

Outcome measures
Measure	Tiotropium n=183 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=173 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day	-0.09 ln(minutes) Standard Error 0.06	-0.14 ln(minutes) Standard Error 0.07

SECONDARY outcome

Timeframe: baseline, week 16

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm

Outcome measures

Outcome measures
Measure	Tiotropium n=183 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=171 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day	-0.20 ln(minutes) Standard Error 0.06	-0.26 ln(minutes) Standard Error 0.07

SECONDARY outcome

Timeframe: baseline, week 20

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm

Outcome measures

Outcome measures
Measure	Tiotropium n=182 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=172 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day	-0.20 ln(minutes) Standard Error 0.07	-0.20 ln(minutes) Standard Error 0.07

SECONDARY outcome

Timeframe: baseline, week 24

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm

Outcome measures

Outcome measures
Measure	Tiotropium n=186 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=167 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day	-0.20 ln(minutes) Standard Error 0.07	-0.19 ln(minutes) Standard Error 0.08

SECONDARY outcome

Timeframe: baseline

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Outcome measures

Outcome measures
Measure	Tiotropium n=203 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=184 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Participants With Healthy Lifestyle (Baseline) Yes	143 Participants	126 Participants
Number of Participants With Healthy Lifestyle (Baseline) No	60 Participants	58 Participants

SECONDARY outcome

Timeframe: week 4

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Outcome measures

Outcome measures
Measure	Tiotropium n=204 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=187 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Participants With Healthy Lifestyle (Week 4) Yes	154 Participants	129 Participants
Number of Participants With Healthy Lifestyle (Week 4) No	50 Participants	58 Participants

SECONDARY outcome

Timeframe: week 8

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Outcome measures

Outcome measures
Measure	Tiotropium n=197 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=191 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Participants With Healthy Lifestyle (Week 8) Yes	137 Participants	125 Participants
Number of Participants With Healthy Lifestyle (Week 8) No	60 Participants	66 Participants

SECONDARY outcome

Timeframe: week 12

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Outcome measures

Outcome measures
Measure	Tiotropium n=199 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=189 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Participants With Healthy Lifestyle (Week 12) Yes	139 Participants	118 Participants
Number of Participants With Healthy Lifestyle (Week 12) No	60 Participants	71 Participants

SECONDARY outcome

Timeframe: week 16

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Outcome measures

Outcome measures
Measure	Tiotropium n=193 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=187 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Participants With Healthy Lifestyle (Week 16) Yes	133 Participants	116 Participants
Number of Participants With Healthy Lifestyle (Week 16) No	60 Participants	71 Participants

SECONDARY outcome

Timeframe: week 20

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Outcome measures

Outcome measures
Measure	Tiotropium n=190 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=188 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Participants With Healthy Lifestyle (Week 20) Yes	134 Participants	127 Participants
Number of Participants With Healthy Lifestyle (Week 20) No	56 Participants	61 Participants

SECONDARY outcome

Timeframe: week 24

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Outcome measures

Outcome measures
Measure	Tiotropium n=196 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=182 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Participants With Healthy Lifestyle (Week 24) Yes	136 Participants	118 Participants
Number of Participants With Healthy Lifestyle (Week 24) No	60 Participants	64 Participants

SECONDARY outcome

Timeframe: baseline

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

The amount of energy (kcal/day) that a person uses while physically active.

Outcome measures

Outcome measures
Measure	Tiotropium n=203 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=184 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Active Energy Expenditure (Baseline)	0.87 kilo calories per day Standard Deviation 0.46	0.87 kilo calories per day Standard Deviation 0.46

SECONDARY outcome

Timeframe: baseline, week 4

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

The amount of energy (kcal/day) that a person uses while physically active.

Outcome measures

Outcome measures
Measure	Tiotropium n=188 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=175 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Active Energy Expenditure (Week 4)	-0.03 kilo calories per day Standard Error 0.02	-0.04 kilo calories per day Standard Error 0.03

SECONDARY outcome

Timeframe: baseline, week 8

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

The amount of energy (kcal/day) that a person uses while physically active.

Outcome measures

Outcome measures
Measure	Tiotropium n=184 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=175 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Active Energy Expenditure (Week 8)	-0.03 kilo calories per day Standard Error 0.03	0.01 kilo calories per day Standard Error 0.03

SECONDARY outcome

Timeframe: baseline, week 12

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

The amount of energy (kcal/day) that a person uses while physically active.

Outcome measures

Outcome measures
Measure	Tiotropium n=185 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=173 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Active Energy Expenditure (Week 12)	-0.06 kilo calories per day Standard Error 0.03	-0.05 kilo calories per day Standard Error 0.03

SECONDARY outcome

Timeframe: baseline, week 16

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

The amount of energy (kcal/day) that a person uses while physically active.

Outcome measures

Outcome measures
Measure	Tiotropium n=183 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=171 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Active Energy Expenditure (Week 16)	-0.09 kilo calories per day Standard Error 0.03	-0.07 kilo calories per day Standard Error 0.03

SECONDARY outcome

Timeframe: baseline, week 20

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

The amount of energy (kcal/day) that a person uses while physically active.

Outcome measures

Outcome measures
Measure	Tiotropium n=182 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=172 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Active Energy Expenditure (Week 20)	-0.09 kilo calories per day Standard Error 0.03	-0.08 kilo calories per day Standard Error 0.04

SECONDARY outcome

Timeframe: baseline, week 24

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

The amount of energy (kcal/day) that a person uses while physically active.

Outcome measures

Outcome measures
Measure	Tiotropium n=186 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=167 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Active Energy Expenditure (Week 24)	-0.10 kilo calories per day Standard Error 0.04	-0.08 kilo calories per day Standard Error 0.04

SECONDARY outcome

Timeframe: baseline

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Number of steps per day (baseline)

Outcome measures

Outcome measures
Measure	Tiotropium n=203 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=184 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Number of Steps Per Day (Baseline)	7366.1 Steps Standard Deviation 3816.0	7343.4 Steps Standard Deviation 3711.8

SECONDARY outcome

Timeframe: baseline, week 4

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Change from baseline in number of steps per day (week 4)

Outcome measures

Outcome measures
Measure	Tiotropium n=188 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=175 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Number of Steps Per Day (Week 4)	-287.45 Steps Standard Error 189.24	-263.91 Steps Standard Error 203.37

SECONDARY outcome

Timeframe: baseline, week 8

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Change from baseline in number of steps per day (week 8)

Outcome measures

Outcome measures
Measure	Tiotropium n=184 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=175 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Number of Steps Per Day(Week 8)	-153.09 Steps Standard Error 203.84	-121.66 Steps Standard Error 214.73

SECONDARY outcome

Timeframe: baseline, week 12

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Change from baseline in Number of steps per day (week 12)

Outcome measures

Outcome measures
Measure	Tiotropium n=185 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=173 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Number of Steps Per Day (Week 12)	-169.31 Steps Standard Error 221.09	-351.30 Steps Standard Error 239.39

SECONDARY outcome

Timeframe: baseline, week 16

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Change from baseline in number of steps per day (week 16)

Outcome measures

Outcome measures
Measure	Tiotropium n=183 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=171 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Number of Steps Per Day (Week 16)	-396.21 Steps Standard Error 217.31	-655.04 Steps Standard Error 231.90

SECONDARY outcome

Timeframe: baseline, week 20

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Change from baseline in number of steps per day (week 20)

Outcome measures

Outcome measures
Measure	Tiotropium n=182 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=172 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Number of Steps Per Day (Week 20)	-197.17 Steps Standard Error 232.96	-408.34 Steps Standard Error 247.32

SECONDARY outcome

Timeframe: baseline, week 24

Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days

Change from baseline in number of steps per day (week 24)

Outcome measures

Outcome measures
Measure	Tiotropium n=186 Participants 18 mcg tiotropium via HandiHaler® + PRN albuterol	Placebo n=167 Participants Placebo matching tiotropium via HandiHaler® + PRN albuterol
Change From Baseline in Number of Steps Per Day (Week 24)	-183.34 Steps Standard Error 232.69	-234.80 Steps Standard Error 261.49

Adverse Events

Placebo

Serious events: 11 serious events

Other events: 31 other events

Deaths: 0 deaths

Tiotropium

Serious events: 10 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=219 participants at risk Placebo matching tiotropium via HandiHaler® + PRN albuterol	Tiotropium n=238 participants at risk 18 mcg tiotropium via HandiHaler® + PRN albuterol
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.46% 1/219 • First drug administration until 30 days after last drug administration	0.00% 0/238 • First drug administration until 30 days after last drug administration
Cardiac disorders Angina pectoris	0.46% 1/219 • First drug administration until 30 days after last drug administration	0.00% 0/238 • First drug administration until 30 days after last drug administration
Cardiac disorders Atrial fibrillation	0.46% 1/219 • First drug administration until 30 days after last drug administration	0.00% 0/238 • First drug administration until 30 days after last drug administration
Cardiac disorders Cardiac failure	0.46% 1/219 • First drug administration until 30 days after last drug administration	0.00% 0/238 • First drug administration until 30 days after last drug administration
Cardiac disorders Coronary artery disease	0.46% 1/219 • First drug administration until 30 days after last drug administration	0.00% 0/238 • First drug administration until 30 days after last drug administration
Cardiac disorders Coronary artery stenosis	0.46% 1/219 • First drug administration until 30 days after last drug administration	0.00% 0/238 • First drug administration until 30 days after last drug administration
Cardiac disorders Myocardial ischaemia	0.46% 1/219 • First drug administration until 30 days after last drug administration	0.00% 0/238 • First drug administration until 30 days after last drug administration
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/219 • First drug administration until 30 days after last drug administration	0.42% 1/238 • First drug administration until 30 days after last drug administration
Gastrointestinal disorders Pancreatitis acute	0.46% 1/219 • First drug administration until 30 days after last drug administration	0.00% 0/238 • First drug administration until 30 days after last drug administration
Gastrointestinal disorders Rectal polyp	0.46% 1/219 • First drug administration until 30 days after last drug administration	0.00% 0/238 • First drug administration until 30 days after last drug administration
Infections and infestations Abdominal abscess	0.00% 0/219 • First drug administration until 30 days after last drug administration	0.42% 1/238 • First drug administration until 30 days after last drug administration
Infections and infestations Joint abscess	0.00% 0/219 • First drug administration until 30 days after last drug administration	0.42% 1/238 • First drug administration until 30 days after last drug administration
Infections and infestations Skin bacterial infection	0.00% 0/219 • First drug administration until 30 days after last drug administration	0.42% 1/238 • First drug administration until 30 days after last drug administration
Infections and infestations Urinary tract infection	0.00% 0/219 • First drug administration until 30 days after last drug administration	0.42% 1/238 • First drug administration until 30 days after last drug administration
Injury, poisoning and procedural complications Hip fracture	0.00% 0/219 • First drug administration until 30 days after last drug administration	0.42% 1/238 • First drug administration until 30 days after last drug administration
Injury, poisoning and procedural complications Renal injury	0.46% 1/219 • First drug administration until 30 days after last drug administration	0.00% 0/238 • First drug administration until 30 days after last drug administration
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/219 • First drug administration until 30 days after last drug administration	0.42% 1/238 • First drug administration until 30 days after last drug administration
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/219 • First drug administration until 30 days after last drug administration	0.42% 1/238 • First drug administration until 30 days after last drug administration
Nervous system disorders Cerebral artery occlusion	0.00% 0/219 • First drug administration until 30 days after last drug administration	0.42% 1/238 • First drug administration until 30 days after last drug administration
Nervous system disorders Cerebral infarction	0.00% 0/219 • First drug administration until 30 days after last drug administration	0.42% 1/238 • First drug administration until 30 days after last drug administration
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.8% 4/219 • First drug administration until 30 days after last drug administration	0.42% 1/238 • First drug administration until 30 days after last drug administration
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.46% 1/219 • First drug administration until 30 days after last drug administration	0.00% 0/238 • First drug administration until 30 days after last drug administration
Respiratory, thoracic and mediastinal disorders Hypoxia	0.46% 1/219 • First drug administration until 30 days after last drug administration	0.00% 0/238 • First drug administration until 30 days after last drug administration

Other adverse events

Other adverse events
Measure	Placebo n=219 participants at risk Placebo matching tiotropium via HandiHaler® + PRN albuterol	Tiotropium n=238 participants at risk 18 mcg tiotropium via HandiHaler® + PRN albuterol
Infections and infestations Nasophayngitis	5.0% 11/219 • First drug administration until 30 days after last drug administration	6.7% 16/238 • First drug administration until 30 days after last drug administration
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	9.6% 21/219 • First drug administration until 30 days after last drug administration	4.6% 11/238 • First drug administration until 30 days after last drug administration

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

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