Trial Outcomes & Findings for Tiotropium In Exercise (NCT NCT00525512)

NCT ID: NCT00525512

Last Updated: 2013-12-24

Results Overview

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

519 participants

Primary outcome timeframe

baseline, 96 weeks

Results posted on

2013-12-24

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Patients randomized to receive treatment with matching placebo	Tiotropium Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Double-Blind Phase STARTED	259	260	0	0
Double-Blind Phase COMPLETED	163	194	0	0
Double-Blind Phase NOT COMPLETED	96	66	0	0
Open-Label Phase STARTED	0	0	164	194
Open-Label Phase COMPLETED	0	0	158	189
Open-Label Phase NOT COMPLETED	0	0	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Patients randomized to receive treatment with matching placebo	Tiotropium Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Double-Blind Phase Adverse Event	48	28	0	0
Double-Blind Phase Protocol Violation	3	1	0	0
Double-Blind Phase Lost to Follow-up	3	7	0	0
Double-Blind Phase Withdrawal by Subject	17	12	0	0
Double-Blind Phase Lack of Efficacy	13	5	0	0
Double-Blind Phase Other reason (not specified)	12	13	0	0
Open-Label Phase Adverse Event	0	0	1	0
Open-Label Phase Lost to Follow-up	0	0	1	0
Open-Label Phase Other reason (not specified)	0	0	4	5

Baseline Characteristics

Tiotropium In Exercise

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=259 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=260 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Total n=519 Participants Total of all reporting groups
Age, Continuous	64.5 years STANDARD_DEVIATION 8.5 • n=5 Participants	64.7 years STANDARD_DEVIATION 8.2 • n=7 Participants	64.6 years STANDARD_DEVIATION 8.3 • n=5 Participants
Age, Customized <= 55	37 participants n=5 Participants	38 participants n=7 Participants	75 participants n=5 Participants
Age, Customized > 55 to <= 65	101 participants n=5 Participants	93 participants n=7 Participants	194 participants n=5 Participants
Age, Customized > 65	121 participants n=5 Participants	129 participants n=7 Participants	250 participants n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	61 Participants n=7 Participants	118 Participants n=5 Participants
Sex: Female, Male Male	202 Participants n=5 Participants	199 Participants n=7 Participants	401 Participants n=5 Participants
Race/Ethnicity, Customized American Indian / Alaskan Native	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Asian	14 participants n=5 Participants	22 participants n=7 Participants	36 participants n=5 Participants
Race/Ethnicity, Customized Black / African American	6 participants n=5 Participants	10 participants n=7 Participants	16 participants n=5 Participants
Race/Ethnicity, Customized Hawaiian / Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized White	237 participants n=5 Participants	226 participants n=7 Participants	463 participants n=5 Participants
Smoking Status Never smoked	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Smoking Status Ex-smoker	174 participants n=5 Participants	169 participants n=7 Participants	343 participants n=5 Participants
Smoking Status Currently smokes	85 participants n=5 Participants	91 participants n=7 Participants	176 participants n=5 Participants
Smoking history	51.04 pack years STANDARD_DEVIATION 26.29 • n=5 Participants	52.15 pack years STANDARD_DEVIATION 28.95 • n=7 Participants	51.6 pack years STANDARD_DEVIATION 27.64 • n=5 Participants
Duration of COPD (Chronic Obstructive Pulmonary Disease)	8.80 years STANDARD_DEVIATION 6.99 • n=5 Participants	8.70 years STANDARD_DEVIATION 6.27 • n=7 Participants	8.75 years STANDARD_DEVIATION 6.63 • n=5 Participants
Height	169.6 centimeters STANDARD_DEVIATION 8.5 • n=5 Participants	169.7 centimeters STANDARD_DEVIATION 9.2 • n=7 Participants	169.7 centimeters STANDARD_DEVIATION 8.9 • n=5 Participants
Weight	77.4 kilograms STANDARD_DEVIATION 15.0 • n=5 Participants	75.4 kilograms STANDARD_DEVIATION 16.0 • n=7 Participants	76.4 kilograms STANDARD_DEVIATION 15.5 • n=5 Participants
BMI (Body Mass Index)	26.8 kilograms / square meter STANDARD_DEVIATION 4.23 • n=5 Participants	26.0 kilograms / square meter STANDARD_DEVIATION 4.38 • n=7 Participants	26.4 kilograms / square meter STANDARD_DEVIATION 4.31 • n=5 Participants
Alcohol status Non drinker	114 participants n=5 Participants	123 participants n=7 Participants	237 participants n=5 Participants
Alcohol status Drinks - no interference with study	145 participants n=5 Participants	137 participants n=7 Participants	282 participants n=5 Participants
Alcohol status Drinks - possible interference with study	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
LABA (Long Acting Beta Agonist) use at randomization No	104 participants n=5 Participants	107 participants n=7 Participants	211 participants n=5 Participants
LABA (Long Acting Beta Agonist) use at randomization Yes	155 participants n=5 Participants	153 participants n=7 Participants	308 participants n=5 Participants
ICS (Inhaled Cortico Steroid) use at randomization No	108 participants n=5 Participants	101 participants n=7 Participants	209 participants n=5 Participants
ICS (Inhaled Cortico Steroid) use at randomization Yes	151 participants n=5 Participants	159 participants n=7 Participants	310 participants n=5 Participants
LABA / ICS use at randomization No	133 participants n=5 Participants	131 participants n=7 Participants	264 participants n=5 Participants
LABA / ICS use at randomization Yes	126 participants n=5 Participants	129 participants n=7 Participants	255 participants n=5 Participants
Anticholinergic use at screening No	139 participants n=5 Participants	139 participants n=7 Participants	278 participants n=5 Participants
Anticholinergic use at screening Yes	120 participants n=5 Participants	121 participants n=7 Participants	241 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 96 weeks

Population: Full Analysis Set (FAS) includes all treated participants with a baseline and any post-dosing exercise duration data

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase	297.1 seconds Interval 265.0 to 333.0	336.6 seconds Interval 302.5 to 374.7	—	—

SECONDARY outcome

Timeframe: baseline, 8 weeks

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase	304.9 seconds Interval 284.7 to 326.5	343.0 seconds Interval 321.2 to 366.2	—	—

SECONDARY outcome

Timeframe: baseline, 16 weeks

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase	308.6 seconds Interval 286.2 to 332.8	338.6 seconds Interval 315.2 to 363.7	—	—

SECONDARY outcome

Timeframe: baseline, 32 weeks

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase	311.8 seconds Interval 286.3 to 339.5	358.7 seconds Interval 330.9 to 388.9	—	—

SECONDARY outcome

Timeframe: baseline, 48 weeks

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase	309.8 seconds Interval 284.0 to 337.9	365.7 seconds Interval 336.8 to 397.0	—	—

SECONDARY outcome

Timeframe: baseline, 64 weeks

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase	313.4 seconds Interval 284.7 to 344.9	349.0 seconds Interval 318.7 to 382.2	—	—

SECONDARY outcome

Timeframe: baseline, 80 weeks

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase	302.8 seconds Interval 273.5 to 335.2	340.1 seconds Interval 309.0 to 374.4	—	—

SECONDARY outcome

Timeframe: baseline, 8 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase	1.082 liters Standard Error 0.017	1.198 liters Standard Error 0.016	—	—

SECONDARY outcome

Timeframe: baseline, 16 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase	1.082 liters Standard Error 0.018	1.164 liters Standard Error 0.017	—	—

SECONDARY outcome

Timeframe: baseline, 32 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase	1.090 liters Standard Error 0.019	1.179 liters Standard Error 0.018	—	—

SECONDARY outcome

Timeframe: baseline, 48 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase	1.066 liters Standard Error 0.019	1.172 liters Standard Error 0.018	—	—

SECONDARY outcome

Timeframe: baseline, 64 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase	1.066 liters Standard Error 0.020	1.157 liters Standard Error 0.019	—	—

SECONDARY outcome

Timeframe: baseline, 80 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase	1.039 liters Standard Error 0.019	1.134 liters Standard Error 0.018	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase	1.050 liters Standard Error 0.021	1.125 liters Standard Error 0.019	—	—

SECONDARY outcome

Timeframe: baseline, 8 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase	1.126 liters Standard Error 0.017	1.280 liters Standard Error 0.017	—	—

SECONDARY outcome

Timeframe: baseline, 16 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase	1.092 liters Standard Error 0.017	1.254 liters Standard Error 0.017	—	—

SECONDARY outcome

Timeframe: baseline, 32 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase	1.113 liters Standard Error 0.018	1.259 liters Standard Error 0.018	—	—

SECONDARY outcome

Timeframe: baseline, 48 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase	1.105 liters Standard Error 0.019	1.232 liters Standard Error 0.018	—	—

SECONDARY outcome

Timeframe: baseline, 64 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase	1.097 liters Standard Error 0.020	1.230 liters Standard Error 0.019	—	—

SECONDARY outcome

Timeframe: baseline, 80 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase	1.079 liters Standard Error 0.020	1.228 liters Standard Error 0.019	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase	1.072 liters Standard Error 0.021	1.202 liters Standard Error 0.019	—	—

SECONDARY outcome

Timeframe: baseline, 8 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase	2.432 liters Standard Error 0.035	2.649 liters Standard Error 0.034	—	—

SECONDARY outcome

Timeframe: baseline, 16 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase	2.407 liters Standard Error 0.038	2.564 liters Standard Error 0.037	—	—

SECONDARY outcome

Timeframe: baseline, 32 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase	2.425 liters Standard Error 0.040	2.607 liters Standard Error 0.038	—	—

SECONDARY outcome

Timeframe: baseline, 48 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase	2.406 liters Standard Error 0.041	2.640 liters Standard Error 0.038	—	—

SECONDARY outcome

Timeframe: baseline, 64 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase	2.423 liters Standard Error 0.046	2.584 liters Standard Error 0.044	—	—

SECONDARY outcome

Timeframe: baseline, 80 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase	2.343 liters Standard Error 0.042	2.555 liters Standard Error 0.040	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase	2.368 liters Standard Error 0.044	2.609 liters Standard Error 0.041	—	—

SECONDARY outcome

Timeframe: baseline, 8 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase	2.529 liters Standard Error 0.038	2.806 liters Standard Error 0.037	—	—

SECONDARY outcome

Timeframe: baseline, 16 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase	2.442 liters Standard Error 0.039	2.767 liters Standard Error 0.037	—	—

SECONDARY outcome

Timeframe: baseline, 32 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase	2.462 liters Standard Error 0.042	2.816 liters Standard Error 0.040	—	—

SECONDARY outcome

Timeframe: baseline, 48 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase	2.499 liters Standard Error 0.041	2.758 liters Standard Error 0.039	—	—

SECONDARY outcome

Timeframe: baseline, 64 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase	2.466 liters Standard Error 0.041	2.767 liters Standard Error 0.039	—	—

SECONDARY outcome

Timeframe: baseline, 80 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase	2.479 liters Standard Error 0.043	2.733 liters Standard Error 0.040	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=238 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase	2.420 liters Standard Error 0.048	2.753 liters Standard Error 0.045	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=193 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase	4.1 units on scale Standard Error 0.16	3.8 units on scale Standard Error 0.14	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase	5.6 unit on scale Standard Error 0.14	5.6 unit on scale Standard Error 0.13	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase	4.0 unit on scale Standard Error 0.18	4.1 unit on scale Standard Error 0.16	—	—

SECONDARY outcome

Timeframe: baseline, 8 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase	-0.04 unit on scale Standard Error 0.999	0.32 unit on scale Standard Error 0.986	—	—

SECONDARY outcome

Timeframe: baseline, 16 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase	0.02 units on scale Standard Error 1.068	0.35 units on scale Standard Error 1.083	—	—

SECONDARY outcome

Timeframe: baseline, 32 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase	-0.04 units on scale Standard Error 1.153	0.30 units on scale Standard Error 1.186	—	—

SECONDARY outcome

Timeframe: baseline, 48 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase	0.03 units on scale Standard Error 1.143	0.25 units on scale Standard Error 1.165	—	—

SECONDARY outcome

Timeframe: baseline, 64 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase	0.03 units on scale Standard Error 1.168	0.25 units on scale Standard Error 1.170	—	—

SECONDARY outcome

Timeframe: baseline, 80 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase	-0.06 units on scale Standard Error 1.217	0.10 units on scale Standard Error 1.132	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase	-0.07 units on scale Standard Error 1.222	0.10 units on scale Standard Error 1.220	—	—

SECONDARY outcome

Timeframe: baseline, 8 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase	-0.03 units on scale Standard Error 1.134	0.34 units on scale Standard Error 1.138	—	—

SECONDARY outcome

Timeframe: baseline, 16 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase	0.07 units on scale Standard Error 1.206	0.30 units on scale Standard Error 1.159	—	—

SECONDARY outcome

Timeframe: baseline, 32 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase	0.13 units on scale Standard Error 1.281	0.20 units on scale Standard Error 1.225	—	—

SECONDARY outcome

Timeframe: baseline, 48 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase	0.02 units on scale Standard Error 1.365	0.18 units on scale Standard Error 1.349	—	—

SECONDARY outcome

Timeframe: baseline, 64 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase	-0.02 units on scale Standard Error 1.250	0.16 units on scale Standard Error 1.424	—	—

SECONDARY outcome

Timeframe: baseline, 80 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase	-0.08 units on scale Standard Error 1.284	0.09 units on scale Standard Error 1.269	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=239 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase	-0.04 units on scale Standard Error 1.455	0.03 units on scale Standard Error 1.348	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Outcome measures

Outcome measures
Measure	Placebo n=216 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=220 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase	44.5 units on scale Standard Error 1.13	40.5 units on scale Standard Error 1.07	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Outcome measures

Outcome measures
Measure	Placebo n=216 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=220 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase	56.9 units on scale Standard Error 1.39	54.6 units on scale Standard Error 1.32	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Outcome measures

Outcome measures
Measure	Placebo n=216 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=220 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase	34.0 units on scale Standard Error 1.25	30.4 units on scale Standard Error 1.20	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Outcome measures

Outcome measures
Measure	Placebo n=216 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=220 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase	54.4 units on scale Standard Error 1.73	45.5 units on scale Standard Error 1.63	—	—

SECONDARY outcome

Timeframe: baseline, 96 weeks

COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.

Outcome measures

Outcome measures
Measure	Placebo n=259 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=260 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase Patients with exacerbations	102 participants	112 participants	—	—
Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase Censored patients	157 participants	148 participants	—	—

SECONDARY outcome

Timeframe: baseline, 100 weeks

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=178 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase	337.25 seconds Interval 297.63 to 382.14	358.80 seconds Interval 318.05 to 404.78	—	—

SECONDARY outcome

Timeframe: baseline, 100 weeks

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=184 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase	1.23 liters Standard Error 0.02	1.23 liters Standard Error 0.02	—	—

SECONDARY outcome

Timeframe: baseline, 100 weeks

FVC is the volume of air that can be forcibly blown out after full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=184 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase	2.72 liters Standard Error 0.05	2.77 liters Standard Error 0.05	—	—

SECONDARY outcome

Timeframe: baseline, 100 weeks

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Outcome measures

Outcome measures
Measure	Placebo n=145 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=168 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase	39.82 units on scale Standard Error 1.28	39.21 units on scale Standard Error 1.21	—	—

SECONDARY outcome

Timeframe: baseline, 100 weeks

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Outcome measures

Outcome measures
Measure	Placebo n=145 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=168 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase	53.57 units on scale Standard Error 1.57	54.46 units on scale Standard Error 1.49	—	—

SECONDARY outcome

Timeframe: baseline, 100 weeks

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Outcome measures

Outcome measures
Measure	Placebo n=146 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=168 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase	29.65 units on scale Standard Error 1.38	29.67 units on scale Standard Error 1.31	—	—

SECONDARY outcome

Timeframe: baseline, 100 weeks

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Outcome measures

Outcome measures
Measure	Placebo n=146 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=169 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium Patients receive open label tiotropium following tiotropium
Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase	45.47 units on scale Standard Error 1.94	41.14 units on scale Standard Error 1.85	—	—

SECONDARY outcome

Timeframe: From first drug administration until 30 days after last drug administration

Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.

Outcome measures

Outcome measures
Measure	Placebo n=259 Participants Patients randomized to receive treatment with matching placebo	Tiotropium n=260 Participants Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium n=164 Participants Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium n=194 Participants Patients receive open label tiotropium following tiotropium
Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status Oxygen saturation decreased	1 participants	0 participants	0 participants	0 participants
Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status Weight decreased	1 participants	2 participants	0 participants	0 participants
Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status Fatal	6 participants	6 participants	0 participants	0 participants
Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status Blood pressure increased	0 participants	2 participants	0 participants	0 participants
Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status Heart rate increased	1 participants	1 participants	1 participants	0 participants

Adverse Events

Placebo

Serious events: 59 serious events

Other events: 135 other events

Deaths: 0 deaths

Tiotropium

Serious events: 63 serious events

Other events: 128 other events

Deaths: 0 deaths

Placebo / Open Tiotropium

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Tiotropium / Open Tiotropium

Serious events: 6 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=259 participants at risk Patients randomized to receive treatment with matching placebo	Tiotropium n=260 participants at risk Patients randomized to treatment with Tiotropium 18 micrograms	Placebo / Open Tiotropium n=164 participants at risk Patients receive open label tiotropium following placebo	Tiotropium / Open Tiotropium n=194 participants at risk Patients receive open label tiotropium following tiotropium
Infections and infestations Nasopharyngitis	8.5% 22/259 • From first drug administration until 30 days after last drug administration.	4.6% 12/260 • From first drug administration until 30 days after last drug administration.	0.00% 0/164 • From first drug administration until 30 days after last drug administration.	1.0% 2/194 • From first drug administration until 30 days after last drug administration.
Infections and infestations Upper respiratory tract infection	5.4% 14/259 • From first drug administration until 30 days after last drug administration.	6.9% 18/260 • From first drug administration until 30 days after last drug administration.	1.2% 2/164 • From first drug administration until 30 days after last drug administration.	0.00% 0/194 • From first drug administration until 30 days after last drug administration.
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 8/259 • From first drug administration until 30 days after last drug administration.	5.4% 14/260 • From first drug administration until 30 days after last drug administration.	0.61% 1/164 • From first drug administration until 30 days after last drug administration.	0.00% 0/194 • From first drug administration until 30 days after last drug administration.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	30.5% 79/259 • From first drug administration until 30 days after last drug administration.	30.4% 79/260 • From first drug administration until 30 days after last drug administration.	3.0% 5/164 • From first drug administration until 30 days after last drug administration.	2.1% 4/194 • From first drug administration until 30 days after last drug administration.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.5% 22/259 • From first drug administration until 30 days after last drug administration.	6.2% 16/260 • From first drug administration until 30 days after last drug administration.	0.00% 0/164 • From first drug administration until 30 days after last drug administration.	0.52% 1/194 • From 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