Trial Outcomes & Findings for Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00400153)

Results Overview

Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1480 participants

Primary outcome timeframe

Before drug administration to 6 hours after drug administration on Day 85

Results posted on

2014-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	COMBIVENT Respimat 20/100 mcg Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Overall Study STARTED	486	491	483
Overall Study COMPLETED	438	436	422
Overall Study NOT COMPLETED	48	55	61

Reasons for withdrawal

Reasons for withdrawal
Measure	COMBIVENT Respimat 20/100 mcg Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Overall Study AE due to study disease worsening	14	19	20
Overall Study AE due to other disease worsening	2	1	0
Overall Study AE due to other condition	3	14	15
Overall Study Protocol Violation	7	4	9
Overall Study Lost to Follow-up	2	1	4
Overall Study Withdrawal by Subject	12	11	10
Overall Study Other reasons - not mentioned above	8	5	3

Baseline Characteristics

Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	COMBIVENT Respimat 20/100 mcg n=486 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=491 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=483 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI	Total n=1460 Participants Total of all reporting groups
Age, Continuous	63.8 years STANDARD_DEVIATION 8.7 • n=5 Participants	64.2 years STANDARD_DEVIATION 9.2 • n=7 Participants	64.3 years STANDARD_DEVIATION 8.6 • n=5 Participants	64.1 years STANDARD_DEVIATION 8.8 • n=4 Participants
Sex: Female, Male Female	170 Participants n=5 Participants	169 Participants n=7 Participants	166 Participants n=5 Participants	505 Participants n=4 Participants
Sex: Female, Male Male	316 Participants n=5 Participants	322 Participants n=7 Participants	317 Participants n=5 Participants	955 Participants n=4 Participants
Race/Ethnicity, Customized White	430 participants n=5 Participants	442 participants n=7 Participants	428 participants n=5 Participants	1300 participants n=4 Participants
Race/Ethnicity, Customized Black	27 participants n=5 Participants	25 participants n=7 Participants	26 participants n=5 Participants	78 participants n=4 Participants
Race/Ethnicity, Customized Asian	29 participants n=5 Participants	24 participants n=7 Participants	29 participants n=5 Participants	82 participants n=4 Participants
Height	168.8 cm STANDARD_DEVIATION 9.1 • n=5 Participants	169.4 cm STANDARD_DEVIATION 9.4 • n=7 Participants	168.8 cm STANDARD_DEVIATION 9.5 • n=5 Participants	169.3 cm STANDARD_DEVIATION 9.3 • n=4 Participants
Weight	78.2 kg STANDARD_DEVIATION 20.0 • n=5 Participants	77.8 kg STANDARD_DEVIATION 19.3 • n=7 Participants	77.3 kg STANDARD_DEVIATION 21.0 • n=5 Participants	77.8 kg STANDARD_DEVIATION 20.1 • n=4 Participants
Alcoholic history Non drinker	223 participants n=5 Participants	232 participants n=7 Participants	223 participants n=5 Participants	678 participants n=4 Participants
Alcoholic history Drinks - not interfere with participation in trial	263 participants n=5 Participants	258 participants n=7 Participants	260 participants n=5 Participants	781 participants n=4 Participants
Alcoholic history Drinks-poss. interfere with participation in trial	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Smoking history	51.7 pack years STANDARD_DEVIATION 27.7 • n=5 Participants	52.4 pack years STANDARD_DEVIATION 27.1 • n=7 Participants	55.4 pack years STANDARD_DEVIATION 27.6 • n=5 Participants	53.2 pack years STANDARD_DEVIATION 27.5 • n=4 Participants
COPD duration	8.2 years STANDARD_DEVIATION 6.1 • n=5 Participants	8.6 years STANDARD_DEVIATION 6.5 • n=7 Participants	8.5 years STANDARD_DEVIATION 6.4 • n=5 Participants	8.4 years STANDARD_DEVIATION 6.3 • n=4 Participants

PRIMARY outcome

Timeframe: Before drug administration to 6 hours after drug administration on Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FEV1 AUC0-6 at Day 85	0.145 liters Standard Error 0.007	0.149 liters Standard Error 0.007	0.119 liters Standard Error 0.007

PRIMARY outcome

Timeframe: Before drug administration to 4 hours after drug administration on Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FEV1 AUC0-4 at Day 85	0.189 liters Standard Error 0.007	0.190 liters Standard Error 0.007	0.142 liters Standard Error 0.007

PRIMARY outcome

Timeframe: Between 4 hours and 6 hours after drug administration on Day 85

Population: Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=447 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=449 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=427 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FEV1 AUC4-6 at Day 85	0.056 liters Standard Error 0.008	0.066 liters Standard Error 0.008	0.073 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Before drug administration to 6 hours after drug administration on Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FEV1 AUC0-6 at Day 1	0.173 liters Standard Error 0.008	0.189 liters Standard Error 0.008	0.124 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Before drug administration to 6 hours after drug administration on Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FEV1 AUC0-6 at Day 29	0.154 liters Standard Error 0.007	0.161 liters Standard Error 0.007	0.127 liters Standard Error 0.007

SECONDARY outcome

Timeframe: Before drug administration to 6 hours after drug administration on Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FEV1 AUC0-6 at Day 57	0.146 liters Standard Error 0.007	0.16 liters Standard Error 0.007	0.118 liters Standard Error 0.007

SECONDARY outcome

Timeframe: Before drug administration to 4 hours after drug administration on Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FEV1 AUC0-4 at Day 1	0.211 liters Standard Error 0.008	0.227 liters Standard Error 0.008	0.149 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Before drug administration to 4 hours after drug administration on Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FEV1 AUC0-4 at Day 29	0.197 liters Standard Error 0.008	0.198 liters Standard Error 0.008	0.153 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Before drug administration to 4 hours after drug administration on Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FEV1 AUC0-4 at Day 57	0.188 liters Standard Error 0.007	0.200 liters Standard Error 0.007	0.141 liters Standard Error 0.007

SECONDARY outcome

Timeframe: Between 4 hours and 6 hours after drug administration on Day 1

Population: Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=447 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=449 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=427 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FEV1 AUC4-6 at Day 1	0.1 liters Standard Error 0.008	0.115 liters Standard Error 0.009	0.074 liters Standard Error 0.009

SECONDARY outcome

Timeframe: Between 4 hours and 6 hours after drug administration on Day 29

Population: Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=447 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=449 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=427 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FEV1 AUC4-6 at Day 29	0.068 liters Standard Error 0.008	0.087 liters Standard Error 0.008	0.078 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Between 4 hours and 6 hours after drug administration on Day 57

Population: Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=447 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=449 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=427 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FEV1 AUC4-6 at Day 57	0.063 liters Standard Error 0.008	0.084 liters Standard Error 0.008	0.073 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval on Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FEV1 Response at Day 1	0.302 liters Standard Error 0.008	0.323 liters Standard Error 0.008	0.237 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval on Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FEV1 Response at Day 29	0.302 liters Standard Error 0.008	0.296 liters Standard Error 0.008	0.237 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval on Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FEV1 Response at Day 57	0.284 liters Standard Error 0.008	0.296 liters Standard Error 0.008	0.223 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval on Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FEV1 Response at Day 85	0.293 liters Standard Error 0.008	0.290 liters Standard Error 0.008	0.225 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval on Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FEV1 Response at Day 1	0.302 liters Standard Error 0.008	0.323 liters Standard Error 0.008	0.237 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval on Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FEV1 Response at Day 29	0.302 liters Standard Error 0.008	0.296 liters Standard Error 0.008	0.237 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval on Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FEV1 Response at Day 57	0.284 liters Standard Error 0.008	0.296 liters Standard Error 0.008	0.223 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval on Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FEV1 Response at Day 85	0.293 liters Standard Error 0.008	0.290 liters Standard Error 0.008	0.225 liters Standard Error 0.008

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval at Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Time to Onset of Therapeutic FEV1 Response at Day 1	13 Minutes Inter-Quartile Range NA • Interval 8.0 to 59.0	12 Minutes Inter-Quartile Range NA • Interval 7.0 to 48.0	28 Minutes Inter-Quartile Range NA • Interval 11.0 to 361.0

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval at Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Time to Onset of Therapeutic FEV1 Response at Day 29	12 Minutes Inter-Quartile Range NA • Interval 7.0 to 53.0	13 Minutes Inter-Quartile Range NA • Interval 8.0 to 55.0	27 Minutes Inter-Quartile Range NA • Interval 11.0 to 361.0

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval at Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Time to Onset of Therapeutic FEV1 Response at Day 57	13 Minutes Inter-Quartile Range NA • Interval 8.0 to 361.0	12 Minutes Inter-Quartile Range NA • Interval 7.0 to 59.0	29 Minutes Inter-Quartile Range NA • Interval 11.0 to 361.0

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval at Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Time to Onset of Therapeutic FEV1 Response at Day 85	12 Minutes Inter-Quartile Range NA • Interval 8.0 to 102.0	13 Minutes Inter-Quartile Range NA • Interval 8.0 to 361.0	27 Minutes Inter-Quartile Range NA • Interval 11.0 to 361.0

SECONDARY outcome

Timeframe: During the 6-hour observation period after drug administration at Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Duration of Therapeutic FEV1 Response at Day 1	189 Minutes Inter-Quartile Range NA • Interval 29.0 to 323.0	219 Minutes Inter-Quartile Range NA • Interval 42.0 to 336.0	104 Minutes Inter-Quartile Range NA • Interval 0.0 to 309.0

SECONDARY outcome

Timeframe: During the 6-hour observation period after drug administration at Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Duration of Therapeutic FEV1 Response at Day 29	170 Minutes Inter-Quartile Range NA • Interval 16.0 to 298.0	178 Minutes Inter-Quartile Range NA • Interval 11.0 to 306.0	122 Minutes Inter-Quartile Range NA • Interval 0.0 to 312.0

SECONDARY outcome

Timeframe: During the 6-hour observation period after drug administration at Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Duration of Therapeutic FEV1 Response at Day 57	165 Minutes Inter-Quartile Range NA • Interval 0.0 to 288.0	194 Minutes Inter-Quartile Range NA • Interval 11.0 to 318.0	84 Minutes Inter-Quartile Range NA • Interval 0.0 to 303.0

SECONDARY outcome

Timeframe: During the 6-hour observation period after drug administration at Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Duration of Therapeutic FEV1 Response at Day 85	168 Minutes Inter-Quartile Range NA • Interval 1.0 to 284.0	172 Minutes Inter-Quartile Range NA • Interval 0.0 to 302.0	70 Minutes Inter-Quartile Range NA • Interval 0.0 to 285.0

SECONDARY outcome

Timeframe: Within the 6-hour post-treatment observation period at Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Time to Peak FEV1 Response at Day 1	60 Minutes Inter-Quartile Range NA • Interval 30.0 to 120.0	60 Minutes Inter-Quartile Range NA • Interval 60.0 to 120.0	120 Minutes Inter-Quartile Range NA • Interval 60.0 to 180.0

SECONDARY outcome

Timeframe: Within the 6-hour post-treatment observation period at Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Time to Peak FEV1 Response at Day 29	60 Minutes Inter-Quartile Range NA • Interval 30.0 to 120.0	60 Minutes Inter-Quartile Range NA • Interval 30.0 to 120.0	120 Minutes Inter-Quartile Range NA • Interval 45.0 to 180.0

SECONDARY outcome

Timeframe: Within the 6-hour post-treatment observation period at Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Time to Peak FEV1 Response at Day 57	60 Minutes Inter-Quartile Range NA • Interval 30.0 to 120.0	60 Minutes Inter-Quartile Range NA • Interval 30.0 to 120.0	60 Minutes Inter-Quartile Range NA • Interval 30.0 to 180.0

SECONDARY outcome

Timeframe: Within the 6-hour post-treatment observation period at Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Time to Peak FEV1 Response at Day 85	60 Minutes Inter-Quartile Range NA • Interval 30.0 to 120.0	60 Minutes Inter-Quartile Range NA • Interval 30.0 to 120.0	60 Minutes Inter-Quartile Range NA • Interval 30.0 to 180.0

SECONDARY outcome

Timeframe: Before drug administration to 6 hours after drug administration at Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FVC AUC0-6 at Day 1	0.337 liters Standard Error 0.015	0.354 liters Standard Error 0.015	0.25 liters Standard Error 0.016

SECONDARY outcome

Timeframe: Before drug administration to 6 hours after drug administration at Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FVC AUC0-6 at Day 29	0.3 liters Standard Error 0.015	0.319 liters Standard Error 0.015	0.246 liters Standard Error 0.015

SECONDARY outcome

Timeframe: Before drug administration to 6 hours after drug administration on Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FVC AUC0-6 at Day 57	0.284 liters Standard Error 0.015	0.303 liters Standard Error 0.015	0.22 liters Standard Error 0.015

SECONDARY outcome

Timeframe: Before drug administration to 6 hours after drug administration on Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FVC AUC0-6 at Day 85	0.279 liters Standard Error 0.015	0.283 liters Standard Error 0.015	0.219 liters Standard Error 0.015

SECONDARY outcome

Timeframe: Before drug administration to 4 hours after drug administration on Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FVC AUC0-4 at Day 1	0.408 liters Standard Error 0.016	0.422 liters Standard Error 0.016	0.297 liters Standard Error 0.016

SECONDARY outcome

Timeframe: Before drug administration to 4 hours after drug administration on Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FVC AUC0-4 at Day 29	0.381 liters Standard Error 0.015	0.388 liters Standard Error 0.015	0.291 liters Standard Error 0.016

SECONDARY outcome

Timeframe: Before drug administration to 4 hours after drug administration on Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FVC AUC0-4 at Day 57	0.361 liters Standard Error 0.015	0.380 liters Standard Error 0.015	0.264 liters Standard Error 0.015

SECONDARY outcome

Timeframe: Before drug administration to 4 hours after drug administration on Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FVC AUC0-4 at Day 85	0.359 liters Standard Error 0.015	0.359 liters Standard Error 0.015	0.265 liters Standard Error 0.015

SECONDARY outcome

Timeframe: Between 4 hours and 6 hours after drug administration on Day 1

Population: Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=447 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=449 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=427 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FVC AUC4-6 at Day 1	0.2 liters Standard Error 0.017	0.221 liters Standard Error 0.017	0.156 liters Standard Error 0.018

SECONDARY outcome

Timeframe: Between 4 hours and 6 hours after drug administration on Day 29

Population: Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=447 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=449 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=427 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FVC AUC4-6 at Day 29	0.137 liters Standard Error 0.017	0.180 liters Standard Error 0.017	0.156 liters Standard Error 0.017

SECONDARY outcome

Timeframe: Between 4 hours and 6 hours after drug administration on Day 57

Population: Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=447 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=449 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=427 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FVC AUC4-6 at Day 57	0.128 liters Standard Error 0.016	0.147 liters Standard Error 0.016	0.13 liters Standard Error 0.017

SECONDARY outcome

Timeframe: Between 4 hours and 6 hours after drug administration on Day 85

Population: Full Analysis Set for Pulmonary Function Test Data 4-6 hours

Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=447 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=449 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=427 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
FVC AUC4-6 at Day 85	0.117 liters Standard Error 0.017	0.130 liters Standard Error 0.017	0.124 liters Standard Error 0.017

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval at Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FVC Response at Day 1	0.6 liters Standard Error 0.017	0.612 liters Standard Error 0.017	0.479 liters Standard Error 0.017

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval at Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FVC Response at Day 29	0.594 liters Standard Error 0.017	0.591 liters Standard Error 0.017	0.465 liters Standard Error 0.017

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval at Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FVC Response at Day 57	0.562 liters Standard Error 0.017	0.577 liters Standard Error 0.017	0.445 liters Standard Error 0.017

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval at Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FVC Response at Day 85	0.575 liters Standard Error 0.017	0.562 liters Standard Error 0.017	0.449 liters Standard Error 0.017

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval at Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FVC Response at Day 1	0.6 liters Standard Error 0.017	0.612 liters Standard Error 0.017	0.479 liters Standard Error 0.017

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval at Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FVC Response at Day 29	0.594 liters Standard Error 0.017	0.591 liters Standard Error 0.017	0.465 liters Standard Error 0.017

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval at Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FVC Response at Day 57	0.562 liters Standard Error 0.017	0.577 liters Standard Error 0.017	0.445 liters Standard Error 0.017

SECONDARY outcome

Timeframe: Within the first 2-hour post-treatment interval at Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=474 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=482 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=468 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Peak FVC Response at Day 85	0.575 liters Standard Error 0.017	0.562 liters Standard Error 0.017	0.449 liters Standard Error 0.017

SECONDARY outcome

Timeframe: During the 6-hour pulmonary function testing after drug administration on Day 1

Population: Treated Set

Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=486 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=491 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=483 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Rescue Medication Use on Pulmonary Test Day 1	8 patients	9 patients	7 patients

SECONDARY outcome

Timeframe: During the 6-hour pulmonary function testing after drug administration on Day 29

Population: Treated Set

Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=486 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=491 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=483 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Rescue Medication Use on Pulmonary Test Day 29	10 patients	7 patients	7 patients

SECONDARY outcome

Timeframe: During the 6-hour pulmonary function testing after drug administration on Day 57

Population: Treated Set

Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=486 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=491 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=483 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Rescue Medication Use on Pulmonary Test Day 57	7 patients	7 patients	6 patients

SECONDARY outcome

Timeframe: During the 6-hour pulmonary function testing after drug administration on Day 85

Population: Treated Set

Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=486 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=491 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=483 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Rescue Medication Use on Pulmonary Test Day 85	5 patients	7 patients	10 patients

SECONDARY outcome

Timeframe: During the 2-week baseline washout period and the 12-week treatment period

Population: Full Analysis Set for Diary Data

The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=471 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=467 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=454 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Night-time Rescue Medication Use	0.977 puffs Standard Error 0.047	0.977 puffs Standard Error 0.047	0.997 puffs Standard Error 0.048

SECONDARY outcome

Timeframe: During the 2-week baseline washout period and the 12-week treatment period

Population: Full Analysis Set for Diary Data

The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=453 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=458 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=438 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Daytime Rescue Medication Use	2.3 puffs Standard Error 0.089	2.191 puffs Standard Error 0.089	2.456 puffs Standard Error 0.09

SECONDARY outcome

Timeframe: During the 2-week baseline washout period and the 12-week treatment period

Population: Full Analysis Set for Diary Data

The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period). Night-time COPD symptoms: 0=none 1=some - slept well 2=woke once 3=woke several times 4=woke most of night

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=471 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=467 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=454 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Night-time Symptom Score	0.922 units on a scale Standard Error 0.023	0.914 units on a scale Standard Error 0.024	0.857 units on a scale Standard Error 0.024

SECONDARY outcome

Timeframe: During the 2-week baseline washout period and the 12-week treatment period

Population: Full Analysis Set for Diary Data

The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period). Daytime COPD symptoms: 0=none 1=occasional 2=frequent, no interference with activities 3=most of day, interference with activities 4=prevent working and activities

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=452 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=456 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=437 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Daytime Symptom Score	1.015 units on a scale Standard Error 0.022	1.002 units on a scale Standard Error 0.022	0.999 units on a scale Standard Error 0.022

SECONDARY outcome

Timeframe: During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication

Population: Full Analysis Set for Diary Data

The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=441 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=444 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=426 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Trough Peak Expiratory Flow Rate (PEFR)	191.95 liters/min Standard Error 1.51	190.290 liters/min Standard Error 1.526	189.51 liters/min Standard Error 1.551

SECONDARY outcome

Timeframe: Prior to pulmonary function test on Day 29

Population: Treated Set

Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=480 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=487 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=481 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Physician's Global Evaluation Score on Pulmonary Function Testing Day 29	4.936 units on a scale Standard Error 0.041	4.859 units on a scale Standard Error 0.041	4.99 units on a scale Standard Error 0.041

SECONDARY outcome

Timeframe: Prior to pulmonary function test on Day 57

Population: Treated Set

Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=480 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=487 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=481 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Physician's Global Evaluation Score on Pulmonary Function Testing Day 57	4.971 units on a scale Standard Error 0.045	4.965 units on a scale Standard Error 0.045	5.04 units on a scale Standard Error 0.046

SECONDARY outcome

Timeframe: Prior to pulmonary function test on Day 85

Population: Treated Set

Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=480 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=487 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=481 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Physician's Global Evaluation Score on Pulmonary Function Testing Day 85	5.115 units on a scale Standard Error 0.048	5.018 units on a scale Standard Error 0.048	5.097 units on a scale Standard Error 0.048

SECONDARY outcome

Timeframe: During the 12-week on-treatment period

Population: Treated Set

COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=486 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=491 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=483 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period	14.81 Percentage of patients	13.03 Percentage of patients	10.35 Percentage of patients

SECONDARY outcome

Timeframe: During the 12-week on-treatment period

Population: Treated Set

Proportion of patients experiencing a COPD exacerbation per patient year. COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=486 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=491 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=483 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
COPD Exacerbation Rate During the On-treatment Period	0.76 Proportion of patients NA	0.69 Proportion of patients NA	0.53 Proportion of patients NA

SECONDARY outcome

Timeframe: During the 12-week on-treatment period

Population: Treated Set

COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=486 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=491 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=483 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
COPD Exacerbation During the On-treatment Period	3.27 Percentage of patients	2.93 Percentage of patients	2.13 Percentage of patients

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated set (US patients)

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=834 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=835 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Frequency Distribution of Satisfaction Rating With Inhaler Attributes Dissatisfied	27 participants	20 participants	—
Frequency Distribution of Satisfaction Rating With Inhaler Attributes Very dissatisfied	16 participants	13 participants	—
Frequency Distribution of Satisfaction Rating With Inhaler Attributes Somewhat dissatisfied	37 participants	17 participants	—
Frequency Distribution of Satisfaction Rating With Inhaler Attributes Satisfied/dissatisfied	54 participants	27 participants	—
Frequency Distribution of Satisfaction Rating With Inhaler Attributes Somewhat satisfied	109 participants	46 participants	—
Frequency Distribution of Satisfaction Rating With Inhaler Attributes Satisfied	351 participants	305 participants	—
Frequency Distribution of Satisfaction Rating With Inhaler Attributes Very satisfied	240 participants	407 participants	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated set (US patients)

Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=834 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=835 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine	5.411 units on a scale Standard Error 0.049	5.810 units on a scale Standard Error 0.049	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated set (US patients)

Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=833 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=835 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung	5.326 units on a scale Standard Error 0.049	5.808 units on a scale Standard Error 0.049	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated set (US patients)

Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=833 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=835 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left	4.573 units on a scale Standard Error 0.057	6.184 units on a scale Standard Error 0.057	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated set (US patients)

Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=834 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=835 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably	5.682 units on a scale Standard Error 0.044	6.190 units on a scale Standard Error 0.044	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated set (US patients)

Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=834 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=835 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler	5.729 units on a scale Standard Error 0.046	6.150 units on a scale Standard Error 0.046	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated set (US patients)

Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=834 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=834 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use	6.048 units on a scale Standard Error 0.036	6.275 units on a scale Standard Error 0.036	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated set (US patients)

Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=834 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=835 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable	6.014 units on a scale Standard Error 0.037	6.279 units on a scale Standard Error 0.037	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated set (US patients)

Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=833 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=835 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler	5.749 units on a scale Standard Error 0.045	6.127 units on a scale Standard Error 0.045	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated set (US patients)

Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=834 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=835 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler	5.715 units on a scale Standard Error 0.047	6.117 units on a scale Standard Error 0.047	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated set (US patients)

Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=834 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=835 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler	5.639 units on a scale Standard Error 0.048	6.103 units on a scale Standard Error 0.048	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated set (US patients)

Frequency of patients due to device preference

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=835 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Device Preference (Respimat or MDI) Prefer Respimat	584 participants	—	—
Device Preference (Respimat or MDI) Prefer MDI	146 participants	—	—
Device Preference (Respimat or MDI) No preference	105 participants	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated set (US patients)

Frequency of patients due to rating of action of turning clear base of Respimat

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=835 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Rating of Action of Turning Clear Base of Respimat Very easy	587 participants	—	—
Rating of Action of Turning Clear Base of Respimat Easy	204 participants	—	—
Rating of Action of Turning Clear Base of Respimat Neither easy nor difficult	40 participants	—	—
Rating of Action of Turning Clear Base of Respimat Difficult	4 participants	—	—
Rating of Action of Turning Clear Base of Respimat Very difficult	0 participants	—	—

SECONDARY outcome

Timeframe: Before drug administration to 6 hours after drug administration on Day 29

Population: All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol.

Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=43 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=49 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=48 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State	128 pg*h/mL Geometric Coefficient of Variation 55.4	123 pg*h/mL Geometric Coefficient of Variation 79.3	115 pg*h/mL Geometric Coefficient of Variation 50.9

SECONDARY outcome

Timeframe: Before drug administration to 6 hours after drug administration on Day 29

Population: All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol

Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=50 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=55 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Noncompartmental Parameters of Albuterol at Steady State	4.09 ng*h/mL Geometric Coefficient of Variation 74.3	5.52 ng*h/mL Geometric Coefficient of Variation 61.4	—

SECONDARY outcome

Timeframe: Before drug administration to 2 hours after drug administration on Day 29

Population: All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol

Cumulative amounts of Ipratropium \[μg\] excreted in urine - Planned time intervals 0-2, ss

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=44 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=51 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=47 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours	0.747 μg Geometric Coefficient of Variation 148	0.692 μg Geometric Coefficient of Variation 180	0.723 μg Geometric Coefficient of Variation 220

SECONDARY outcome

Timeframe: Before drug administration to 2 hours after drug administration on Day 29

Population: All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol

Cumulative amounts of Albuterol \[μg\] excreted in urine - Planned time intervals 0-2,ss.

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=46 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=52 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours	14.7 μg Geometric Coefficient of Variation 143	20.3 μg Geometric Coefficient of Variation 141	—

SECONDARY outcome

Timeframe: Before drug administration to 6 hours after drug administration on Day 26

Population: All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol

Cumulative amounts of Ipratropium \[μg\] excreted in urine - Planned time intervals 0-6,ss

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=48 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=55 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg n=51 Participants Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours	1.66 μg Geometric Coefficient of Variation 128	1.41 μg Geometric Coefficient of Variation 143	1.51 μg Geometric Coefficient of Variation 145

SECONDARY outcome

Timeframe: Before drug administration to 6 hours after drug administration on Day 29

Population: All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol

Cumulative amounts of Albuterol \[μg\] excreted in urine - Planned time intervals 0-6, ss

Outcome measures

Outcome measures
Measure	COMBIVENT Respimat 20/100 mcg n=49 Participants Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg n=55 Participants COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours	33.7 μg Geometric Coefficient of Variation 123	39.4 μg Geometric Coefficient of Variation 116	—

Adverse Events

COMBIVENT Respimat 20/100 mcg

Serious events: 17 serious events

Other events: 61 other events

Deaths: 0 deaths

COMBIVENT CFC-MDI 36/206 mcg

Serious events: 33 serious events

Other events: 51 other events

Deaths: 0 deaths

Ipratropium Respimat 20 mcg

Serious events: 14 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	COMBIVENT Respimat 20/100 mcg Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Cardiac disorders Atrial Fibrillation	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Cardiac disorders Coronary artery disease	0.21% 1/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.00% 0/483 • 12 weeks
Gastrointestinal disorders Constipation	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Gastrointestinal disorders Haemorrhoids	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Gastrointestinal disorders Inguinal hernia	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
General disorders Chest pain	0.00% 0/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.21% 1/483 • 12 weeks
General disorders Death	0.21% 1/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.00% 0/483 • 12 weeks
General disorders Oedema peripheral	0.00% 0/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.21% 1/483 • 12 weeks
Infections and infestations Abscess limb	0.21% 1/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.00% 0/483 • 12 weeks
Infections and infestations Appendicitis	0.21% 1/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.00% 0/483 • 12 weeks
Infections and infestations Bronchitis	0.62% 3/486 • 12 weeks	0.41% 2/491 • 12 weeks	0.00% 0/483 • 12 weeks
Infections and infestations Cellulitis	0.21% 1/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.00% 0/483 • 12 weeks
Infections and infestations Diverticulitis	0.21% 1/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.00% 0/483 • 12 weeks
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.21% 1/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Infections and infestations Lobar pneumonia	0.00% 0/486 • 12 weeks	0.41% 2/491 • 12 weeks	0.21% 1/483 • 12 weeks
Infections and infestations Pneumonia	0.41% 2/486 • 12 weeks	0.61% 3/491 • 12 weeks	0.62% 3/483 • 12 weeks
Infections and infestations Tracheobronchitis	0.21% 1/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.00% 0/483 • 12 weeks
Injury, poisoning and procedural complications Incisional hernia	0.21% 1/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.00% 0/483 • 12 weeks
Injury, poisoning and procedural complications Injury	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.21% 1/483 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.00% 0/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.21% 1/483 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/486 • 12 weeks	0.41% 2/491 • 12 weeks	0.00% 0/483 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.21% 1/483 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.21% 1/483 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.21% 1/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.00% 0/483 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma	0.00% 0/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.21% 1/483 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Nervous system disorders Cerebral cyst	0.00% 0/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.21% 1/483 • 12 weeks
Nervous system disorders Loss of consciousness	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Nervous system disorders Syncope	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.1% 10/486 • 12 weeks	2.4% 12/491 • 12 weeks	1.7% 8/483 • 12 weeks
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/486 • 12 weeks	0.41% 2/491 • 12 weeks	0.00% 0/483 • 12 weeks
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.21% 1/483 • 12 weeks
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.21% 1/483 • 12 weeks
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.21% 1/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.00% 0/483 • 12 weeks
Vascular disorders Angiopathy	0.00% 0/486 • 12 weeks	0.20% 1/491 • 12 weeks	0.00% 0/483 • 12 weeks
Vascular disorders Thrombophlebitis	0.00% 0/486 • 12 weeks	0.00% 0/491 • 12 weeks	0.21% 1/483 • 12 weeks

Other adverse events

Other adverse events
Measure	COMBIVENT Respimat 20/100 mcg Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	COMBIVENT CFC-MDI 36/206 mcg COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	12.6% 61/486 • 12 weeks	10.4% 51/491 • 12 weeks	8.9% 43/483 • 12 weeks

Additional Information

Boehringer Ingelheim Pharmaceuticals

Phone: 800-542-6257 Option 4

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