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

Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00400153

Enrollment

1480

Registered

2006-11-16

Start date

2006-11-30

Completion date

Unknown

Last updated

2014-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Brief summary

The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.

Interventions

DRUGAtrovent Respimat (20 mcg)

DRUGCOMBIVENT MDI (36/206 mcg)

DRUGCombivent Respimat (20 mcg/100 mcg)

DRUGPlacebo via corresponding inhaler for blinding purposes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).

Exclusion criteria

Patients with significant diseases other than COPD that may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study, with a history of asthma or allergic rhinitis, who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy or using oral corticosteroid me dication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day will be excluded.

Design outcomes

Primary

Measure	Time frame	Description
FEV1 AUC0-6 at Day 85	Before drug administration to 6 hours after drug administration on Day 85	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
FEV1 AUC0-4 at Day 85	Before drug administration to 4 hours after drug administration on Day 85	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
FEV1 AUC4-6 at Day 85	Between 4 hours and 6 hours after drug administration on Day 85	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

Secondary

Measure	Time frame	Description
FEV1 AUC0-4 at Day 1	Before drug administration to 4 hours after drug administration on Day 1	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
FEV1 AUC0-4 at Day 29	Before drug administration to 4 hours after drug administration on Day 29	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
FEV1 AUC0-4 at Day 57	Before drug administration to 4 hours after drug administration on Day 57	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
FEV1 AUC4-6 at Day 1	Between 4 hours and 6 hours after drug administration on Day 1	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
FEV1 AUC4-6 at Day 29	Between 4 hours and 6 hours after drug administration on Day 29	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
FEV1 AUC4-6 at Day 57	Between 4 hours and 6 hours after drug administration on Day 57	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
Peak FEV1 Response at Day 1	Within the first 2-hour post-treatment interval on Day 1	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
Peak FEV1 Response at Day 29	Within the first 2-hour post-treatment interval on Day 29	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
Peak FEV1 Response at Day 57	Within the first 2-hour post-treatment interval on Day 57	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
Peak FEV1 Response at Day 85	Within the first 2-hour post-treatment interval on Day 85	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
Time to Onset of Therapeutic FEV1 Response at Day 1	Within the first 2-hour post-treatment interval at Day 1	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
Time to Onset of Therapeutic FEV1 Response at Day 29	Within the first 2-hour post-treatment interval at Day 29	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
Time to Onset of Therapeutic FEV1 Response at Day 57	Within the first 2-hour post-treatment interval at Day 57	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
Time to Onset of Therapeutic FEV1 Response at Day 85	Within the first 2-hour post-treatment interval at Day 85	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
Duration of Therapeutic FEV1 Response at Day 1	During the 6-hour observation period after drug administration at Day 1	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
Duration of Therapeutic FEV1 Response at Day 29	During the 6-hour observation period after drug administration at Day 29	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
Duration of Therapeutic FEV1 Response at Day 57	During the 6-hour observation period after drug administration at Day 57	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
Duration of Therapeutic FEV1 Response at Day 85	During the 6-hour observation period after drug administration at Day 85	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
Time to Peak FEV1 Response at Day 1	Within the 6-hour post-treatment observation period at Day 1	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
Time to Peak FEV1 Response at Day 29	Within the 6-hour post-treatment observation period at Day 29	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
Time to Peak FEV1 Response at Day 57	Within the 6-hour post-treatment observation period at Day 57	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
Time to Peak FEV1 Response at Day 85	Within the 6-hour post-treatment observation period at Day 85	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
FVC AUC0-6 at Day 1	Before drug administration to 6 hours after drug administration at Day 1	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
FVC AUC0-6 at Day 29	Before drug administration to 6 hours after drug administration at Day 29	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
FVC AUC0-6 at Day 57	Before drug administration to 6 hours after drug administration on Day 57	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
FVC AUC0-6 at Day 85	Before drug administration to 6 hours after drug administration on Day 85	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
FVC AUC0-4 at Day 1	Before drug administration to 4 hours after drug administration on Day 1	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
FVC AUC0-4 at Day 29	Before drug administration to 4 hours after drug administration on Day 29	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
FVC AUC0-4 at Day 57	Before drug administration to 4 hours after drug administration on Day 57	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
FVC AUC0-4 at Day 85	Before drug administration to 4 hours after drug administration on Day 85	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
FVC AUC4-6 at Day 1	Between 4 hours and 6 hours after drug administration on Day 1	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
FVC AUC4-6 at Day 29	Between 4 hours and 6 hours after drug administration on Day 29	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
FVC AUC4-6 at Day 57	Between 4 hours and 6 hours after drug administration on Day 57	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
FVC AUC4-6 at Day 85	Between 4 hours and 6 hours after drug administration on Day 85	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
Peak FVC Response at Day 1	Within the first 2-hour post-treatment interval at Day 1	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
Peak FVC Response at Day 29	Within the first 2-hour post-treatment interval at Day 29	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
Peak FVC Response at Day 57	Within the first 2-hour post-treatment interval at Day 57	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
Peak FVC Response at Day 85	Within the first 2-hour post-treatment interval at Day 85	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
Rescue Medication Use on Pulmonary Test Day 1	During the 6-hour pulmonary function testing after drug administration on Day 1	Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1
Rescue Medication Use on Pulmonary Test Day 29	During the 6-hour pulmonary function testing after drug administration on Day 29	Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29
Rescue Medication Use on Pulmonary Test Day 57	During the 6-hour pulmonary function testing after drug administration on Day 57	Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57
Rescue Medication Use on Pulmonary Test Day 85	During the 6-hour pulmonary function testing after drug administration on Day 85	Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85
Night-time Rescue Medication Use	During the 2-week baseline washout period and the 12-week treatment period	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)
Daytime Rescue Medication Use	During the 2-week baseline washout period and the 12-week treatment period	The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)
Night-time Symptom Score	During the 2-week baseline washout period and the 12-week treatment period	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
Daytime Symptom Score	During the 2-week baseline washout period and the 12-week treatment period	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
Trough Peak Expiratory Flow Rate (PEFR)	During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication	The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)
Physician's Global Evaluation Score on Pulmonary Function Testing Day 29	Prior to pulmonary function test on Day 29	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.
Physician's Global Evaluation Score on Pulmonary Function Testing Day 57	Prior to pulmonary function test on Day 57	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.
Physician's Global Evaluation Score on Pulmonary Function Testing Day 85	Prior to pulmonary function test on Day 85	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.
Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period	During the 12-week on-treatment period	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.
COPD Exacerbation Rate During the On-treatment Period	During the 12-week on-treatment period	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.
COPD Exacerbation During the On-treatment Period	During the 12-week on-treatment period	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.
Frequency Distribution of Satisfaction Rating With Inhaler Attributes	12 weeks	—
Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine	12 weeks	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.
Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung	12 weeks	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.
Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left	12 weeks	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.
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably	12 weeks	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.
Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler	12 weeks	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.
Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use	12 weeks	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.
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable	12 weeks	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.
Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler	12 weeks	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.
Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler	12 weeks	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.
Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler	12 weeks	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.
Device Preference (Respimat or MDI)	12 weeks	Frequency of patients due to device preference
FEV1 AUC0-6 at Day 1	Before drug administration to 6 hours after drug administration on Day 1	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
Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State	Before drug administration to 6 hours after drug administration on Day 29	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).
Noncompartmental Parameters of Albuterol at Steady State	Before drug administration to 6 hours after drug administration on Day 29	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).
Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours	Before drug administration to 2 hours after drug administration on Day 29	Cumulative amounts of Ipratropium \[μg\] excreted in urine - Planned time intervals 0-2, ss
Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours	Before drug administration to 2 hours after drug administration on Day 29	Cumulative amounts of Albuterol \[μg\] excreted in urine - Planned time intervals 0-2,ss.
Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours	Before drug administration to 6 hours after drug administration on Day 26	Cumulative amounts of Ipratropium \[μg\] excreted in urine - Planned time intervals 0-6,ss
Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours	Before drug administration to 6 hours after drug administration on Day 29	Cumulative amounts of Albuterol \[μg\] excreted in urine - Planned time intervals 0-6, ss
Rating of Action of Turning Clear Base of Respimat	12 weeks	Frequency of patients due to rating of action of turning clear base of Respimat
FEV1 AUC0-6 at Day 29	Before drug administration to 6 hours after drug administration on Day 29	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
FEV1 AUC0-6 at Day 57	Before drug administration to 6 hours after drug administration on Day 57	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

Countries

Argentina, France, Greece, New Zealand, Poland, Russia, South Africa, South Korea, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States

Participant flow

Participants by arm

Arm	Count
COMBIVENT Respimat 20/100 mcg Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI	486
COMBIVENT CFC-MDI 36/206 mcg COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat	491
Ipratropium Respimat 20 mcg Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI	483
Total	1,460

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	AE due to other condition	3	14	15
Overall Study	AE due to other disease worsening	2	1	0
Overall Study	AE due to study disease worsening	14	19	20
Overall Study	Lost to Follow-up	2	1	4
Overall Study	Other reasons - not mentioned above	8	5	3
Overall Study	Protocol Violation	7	4	9
Overall Study	Withdrawal by Subject	12	11	10

Baseline characteristics

Characteristic	Total	COMBIVENT Respimat 20/100 mcg	COMBIVENT CFC-MDI 36/206 mcg	Ipratropium Respimat 20 mcg
Age, Continuous	64.1 years STANDARD_DEVIATION 8.8	63.8 years STANDARD_DEVIATION 8.7	64.2 years STANDARD_DEVIATION 9.2	64.3 years STANDARD_DEVIATION 8.6
Alcoholic history Drinks - not interfere with participation in trial	781 participants	263 participants	258 participants	260 participants
Alcoholic history Drinks-poss. interfere with participation in trial	1 participants	0 participants	1 participants	0 participants
Alcoholic history Non drinker	678 participants	223 participants	232 participants	223 participants
COPD duration	8.4 years STANDARD_DEVIATION 6.3	8.2 years STANDARD_DEVIATION 6.1	8.6 years STANDARD_DEVIATION 6.5	8.5 years STANDARD_DEVIATION 6.4
Height	169.3 cm STANDARD_DEVIATION 9.3	168.8 cm STANDARD_DEVIATION 9.1	169.4 cm STANDARD_DEVIATION 9.4	168.8 cm STANDARD_DEVIATION 9.5
Race/Ethnicity, Customized Asian	82 participants	29 participants	24 participants	29 participants
Race/Ethnicity, Customized Black	78 participants	27 participants	25 participants	26 participants
Race/Ethnicity, Customized White	1300 participants	430 participants	442 participants	428 participants
Sex: Female, Male Female	505 Participants	170 Participants	169 Participants	166 Participants
Sex: Female, Male Male	955 Participants	316 Participants	322 Participants	317 Participants
Smoking history	53.2 pack years STANDARD_DEVIATION 27.5	51.7 pack years STANDARD_DEVIATION 27.7	52.4 pack years STANDARD_DEVIATION 27.1	55.4 pack years STANDARD_DEVIATION 27.6
Weight	77.8 kg STANDARD_DEVIATION 20.1	78.2 kg STANDARD_DEVIATION 20	77.8 kg STANDARD_DEVIATION 19.3	77.3 kg STANDARD_DEVIATION 21

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	61 / —	51 / —	43 / —
serious Total, serious adverse events	17 / —	33 / —	14 / —

Outcome results

Primary

FEV1 AUC0-4 at Day 85

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

Time frame: Before drug administration to 4 hours after drug administration on Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FEV1 AUC0-4 at Day 85	0.189 liters	Standard Error 0.007
COMBIVENT CFC-MDI 36/206 mcg	FEV1 AUC0-4 at Day 85	0.190 liters	Standard Error 0.007
Ipratropium Respimat 20 mcg	FEV1 AUC0-4 at Day 85	0.142 liters	Standard Error 0.007

p-value: <0.000195% CI: [0.028, 0.066]ANCOVA

Primary

FEV1 AUC0-6 at Day 85

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

Time frame: Before drug administration to 6 hours after drug administration on Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FEV1 AUC0-6 at Day 85	0.145 liters	Standard Error 0.007
COMBIVENT CFC-MDI 36/206 mcg	FEV1 AUC0-6 at Day 85	0.149 liters	Standard Error 0.007
Ipratropium Respimat 20 mcg	FEV1 AUC0-6 at Day 85	0.119 liters	Standard Error 0.007

p-value: 0.713595% CI: [-0.0222, 0.0152]ANCOVA

Primary

FEV1 AUC4-6 at Day 85

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

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

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FEV1 AUC4-6 at Day 85	0.056 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	FEV1 AUC4-6 at Day 85	0.066 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	FEV1 AUC4-6 at Day 85	0.073 liters	Standard Error 0.008

p-value: 0.138995% CI: [-0.039, 0.005]ANCOVA

Secondary

COPD Exacerbation During the On-treatment Period

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.

Time frame: During the 12-week on-treatment period

Population: Treated Set

Arm	Measure	Value (NUMBER)
COMBIVENT Respimat 20/100 mcg	COPD Exacerbation During the On-treatment Period	3.27 Percentage of patients
COMBIVENT CFC-MDI 36/206 mcg	COPD Exacerbation During the On-treatment Period	2.93 Percentage of patients
Ipratropium Respimat 20 mcg	COPD Exacerbation During the On-treatment Period	2.13 Percentage of patients

Secondary

COPD Exacerbation Rate During the On-treatment Period

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.

Time frame: During the 12-week on-treatment period

Population: Treated Set

Arm	Measure	Value (NUMBER)
COMBIVENT Respimat 20/100 mcg	COPD Exacerbation Rate During the On-treatment Period	0.76 Proportion of patients
COMBIVENT CFC-MDI 36/206 mcg	COPD Exacerbation Rate During the On-treatment Period	0.69 Proportion of patients
Ipratropium Respimat 20 mcg	COPD Exacerbation Rate During the On-treatment Period	0.53 Proportion of patients

Secondary

Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours

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

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours	14.7 μg	Geometric Coefficient of Variation 143
COMBIVENT CFC-MDI 36/206 mcg	Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours	20.3 μg	Geometric Coefficient of Variation 141

Secondary

Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours

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

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours	33.7 μg	Geometric Coefficient of Variation 123
COMBIVENT CFC-MDI 36/206 mcg	Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours	39.4 μg	Geometric Coefficient of Variation 116

Secondary

Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours

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

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours	0.747 μg	Geometric Coefficient of Variation 148
COMBIVENT CFC-MDI 36/206 mcg	Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours	0.692 μg	Geometric Coefficient of Variation 180
Ipratropium Respimat 20 mcg	Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours	0.723 μg	Geometric Coefficient of Variation 220

Secondary

Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours

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

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours	1.66 μg	Geometric Coefficient of Variation 128
COMBIVENT CFC-MDI 36/206 mcg	Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours	1.41 μg	Geometric Coefficient of Variation 143
Ipratropium Respimat 20 mcg	Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours	1.51 μg	Geometric Coefficient of Variation 145

Secondary

Daytime Rescue Medication Use

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

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

Population: Full Analysis Set for Diary Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Daytime Rescue Medication Use	2.3 puffs	Standard Error 0.089
COMBIVENT CFC-MDI 36/206 mcg	Daytime Rescue Medication Use	2.191 puffs	Standard Error 0.089
Ipratropium Respimat 20 mcg	Daytime Rescue Medication Use	2.456 puffs	Standard Error 0.09

p-value: 0.365995% CI: [-0.1276, 0.3458]ANCOVA

Comparison: This analysis is purely exploratory.p-value: 0.20395% CI: [-0.3947, 0.08395]ANCOVA

Secondary

Daytime Symptom Score

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

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

Population: Full Analysis Set for Diary Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Daytime Symptom Score	1.015 units on a scale	Standard Error 0.022
COMBIVENT CFC-MDI 36/206 mcg	Daytime Symptom Score	1.002 units on a scale	Standard Error 0.022
Ipratropium Respimat 20 mcg	Daytime Symptom Score	0.999 units on a scale	Standard Error 0.022

p-value: 0.667495% CI: [-0.04598, 0.07179]ANCOVA

Comparison: This analysis is purely exploratory.p-value: 0.60495% CI: [-0.04376, 0.07523]ANCOVA

Secondary

Device Preference (Respimat or MDI)

Frequency of patients due to device preference

Time frame: 12 weeks

Population: Treated set (US patients)

Arm	Measure	Group	Value (NUMBER)
COMBIVENT Respimat 20/100 mcg	Device Preference (Respimat or MDI)	Prefer Respimat	584 participants
COMBIVENT Respimat 20/100 mcg	Device Preference (Respimat or MDI)	Prefer MDI	146 participants
COMBIVENT Respimat 20/100 mcg	Device Preference (Respimat or MDI)	No preference	105 participants

Secondary

Duration of Therapeutic FEV1 Response at Day 1

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (MEDIAN)
COMBIVENT Respimat 20/100 mcg	Duration of Therapeutic FEV1 Response at Day 1	189 Minutes
COMBIVENT CFC-MDI 36/206 mcg	Duration of Therapeutic FEV1 Response at Day 1	219 Minutes
Ipratropium Respimat 20 mcg	Duration of Therapeutic FEV1 Response at Day 1	104 Minutes

Secondary

Duration of Therapeutic FEV1 Response at Day 29

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (MEDIAN)
COMBIVENT Respimat 20/100 mcg	Duration of Therapeutic FEV1 Response at Day 29	170 Minutes
COMBIVENT CFC-MDI 36/206 mcg	Duration of Therapeutic FEV1 Response at Day 29	178 Minutes
Ipratropium Respimat 20 mcg	Duration of Therapeutic FEV1 Response at Day 29	122 Minutes

Secondary

Duration of Therapeutic FEV1 Response at Day 57

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (MEDIAN)
COMBIVENT Respimat 20/100 mcg	Duration of Therapeutic FEV1 Response at Day 57	165 Minutes
COMBIVENT CFC-MDI 36/206 mcg	Duration of Therapeutic FEV1 Response at Day 57	194 Minutes
Ipratropium Respimat 20 mcg	Duration of Therapeutic FEV1 Response at Day 57	84 Minutes

Secondary

Duration of Therapeutic FEV1 Response at Day 85

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (MEDIAN)
COMBIVENT Respimat 20/100 mcg	Duration of Therapeutic FEV1 Response at Day 85	168 Minutes
COMBIVENT CFC-MDI 36/206 mcg	Duration of Therapeutic FEV1 Response at Day 85	172 Minutes
Ipratropium Respimat 20 mcg	Duration of Therapeutic FEV1 Response at Day 85	70 Minutes

Secondary

FEV1 AUC0-4 at Day 1

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

Time frame: Before drug administration to 4 hours after drug administration on Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FEV1 AUC0-4 at Day 1	0.211 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	FEV1 AUC0-4 at Day 1	0.227 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	FEV1 AUC0-4 at Day 1	0.149 liters	Standard Error 0.008

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.04, 0.083]ANCOVA

Secondary

FEV1 AUC0-4 at Day 29

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

Time frame: Before drug administration to 4 hours after drug administration on Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FEV1 AUC0-4 at Day 29	0.197 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	FEV1 AUC0-4 at Day 29	0.198 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	FEV1 AUC0-4 at Day 29	0.153 liters	Standard Error 0.008

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.024, 0.065]ANCOVA

Secondary

FEV1 AUC0-4 at Day 57

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

Time frame: Before drug administration to 4 hours after drug administration on Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FEV1 AUC0-4 at Day 57	0.188 liters	Standard Error 0.007
COMBIVENT CFC-MDI 36/206 mcg	FEV1 AUC0-4 at Day 57	0.200 liters	Standard Error 0.007
Ipratropium Respimat 20 mcg	FEV1 AUC0-4 at Day 57	0.141 liters	Standard Error 0.007

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.027, 0.067]ANCOVA

Secondary

FEV1 AUC0-6 at Day 1

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

Time frame: Before drug administration to 6 hours after drug administration on Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FEV1 AUC0-6 at Day 1	0.173 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	FEV1 AUC0-6 at Day 1	0.189 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	FEV1 AUC0-6 at Day 1	0.124 liters	Standard Error 0.008

p-value: 0.12495% CI: [-0.036, 0.004]ANCOVA

Secondary

FEV1 AUC0-6 at Day 29

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

Time frame: Before drug administration to 6 hours after drug administration on Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FEV1 AUC0-6 at Day 29	0.154 liters	Standard Error 0.007
COMBIVENT CFC-MDI 36/206 mcg	FEV1 AUC0-6 at Day 29	0.161 liters	Standard Error 0.007
Ipratropium Respimat 20 mcg	FEV1 AUC0-6 at Day 29	0.127 liters	Standard Error 0.007

p-value: 0.488895% CI: [-0.026, 0.013]ANCOVA

Secondary

FEV1 AUC0-6 at Day 57

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

Time frame: Before drug administration to 6 hours after drug administration on Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FEV1 AUC0-6 at Day 57	0.146 liters	Standard Error 0.007
COMBIVENT CFC-MDI 36/206 mcg	FEV1 AUC0-6 at Day 57	0.16 liters	Standard Error 0.007
Ipratropium Respimat 20 mcg	FEV1 AUC0-6 at Day 57	0.118 liters	Standard Error 0.007

p-value: 0.143395% CI: [-0.033, 0.005]ANCOVA

Secondary

FEV1 AUC4-6 at Day 1

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

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

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FEV1 AUC4-6 at Day 1	0.1 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	FEV1 AUC4-6 at Day 1	0.115 liters	Standard Error 0.009
Ipratropium Respimat 20 mcg	FEV1 AUC4-6 at Day 1	0.074 liters	Standard Error 0.009

p-value: 0.025895% CI: [0.003, 0.049]ANCOVA

Secondary

FEV1 AUC4-6 at Day 29

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

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

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FEV1 AUC4-6 at Day 29	0.068 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	FEV1 AUC4-6 at Day 29	0.087 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	FEV1 AUC4-6 at Day 29	0.078 liters	Standard Error 0.008

p-value: 0.374995% CI: [-0.032, 0.012]ANCOVA

Secondary

FEV1 AUC4-6 at Day 57

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

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

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FEV1 AUC4-6 at Day 57	0.063 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	FEV1 AUC4-6 at Day 57	0.084 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	FEV1 AUC4-6 at Day 57	0.073 liters	Standard Error 0.008

p-value: 0.335595% CI: [-0.033, 0.011]ANCOVA

Secondary

Frequency Distribution of Satisfaction Rating With Inhaler Attributes

Time frame: 12 weeks

Population: Treated set (US patients)

Arm	Measure	Group	Value (NUMBER)
COMBIVENT Respimat 20/100 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Somewhat dissatisfied	37 participants
COMBIVENT Respimat 20/100 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Somewhat satisfied	109 participants
COMBIVENT Respimat 20/100 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Dissatisfied	27 participants
COMBIVENT Respimat 20/100 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Satisfied	351 participants
COMBIVENT Respimat 20/100 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Satisfied/dissatisfied	54 participants
COMBIVENT Respimat 20/100 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Very satisfied	240 participants
COMBIVENT Respimat 20/100 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Very dissatisfied	16 participants
COMBIVENT CFC-MDI 36/206 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Very satisfied	407 participants
COMBIVENT CFC-MDI 36/206 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Very dissatisfied	13 participants
COMBIVENT CFC-MDI 36/206 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Dissatisfied	20 participants
COMBIVENT CFC-MDI 36/206 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Somewhat dissatisfied	17 participants
COMBIVENT CFC-MDI 36/206 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Satisfied/dissatisfied	27 participants
COMBIVENT CFC-MDI 36/206 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Somewhat satisfied	46 participants
COMBIVENT CFC-MDI 36/206 mcg	Frequency Distribution of Satisfaction Rating With Inhaler Attributes	Satisfied	305 participants

Secondary

FVC AUC0-4 at Day 1

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

Time frame: Before drug administration to 4 hours after drug administration on Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FVC AUC0-4 at Day 1	0.408 liters	Standard Error 0.016
COMBIVENT CFC-MDI 36/206 mcg	FVC AUC0-4 at Day 1	0.422 liters	Standard Error 0.016
Ipratropium Respimat 20 mcg	FVC AUC0-4 at Day 1	0.297 liters	Standard Error 0.016

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.069, 0.154]ANCOVA

Secondary

FVC AUC0-4 at Day 29

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

Time frame: Before drug administration to 4 hours after drug administration on Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FVC AUC0-4 at Day 29	0.381 liters	Standard Error 0.015
COMBIVENT CFC-MDI 36/206 mcg	FVC AUC0-4 at Day 29	0.388 liters	Standard Error 0.015
Ipratropium Respimat 20 mcg	FVC AUC0-4 at Day 29	0.291 liters	Standard Error 0.016

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.049, 0.132]ANCOVA

Secondary

FVC AUC0-4 at Day 57

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

Time frame: Before drug administration to 4 hours after drug administration on Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FVC AUC0-4 at Day 57	0.361 liters	Standard Error 0.015
COMBIVENT CFC-MDI 36/206 mcg	FVC AUC0-4 at Day 57	0.380 liters	Standard Error 0.015
Ipratropium Respimat 20 mcg	FVC AUC0-4 at Day 57	0.264 liters	Standard Error 0.015

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.056, 0.138]ANCOVA

Secondary

FVC AUC0-4 at Day 85

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

Time frame: Before drug administration to 4 hours after drug administration on Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FVC AUC0-4 at Day 85	0.359 liters	Standard Error 0.015
COMBIVENT CFC-MDI 36/206 mcg	FVC AUC0-4 at Day 85	0.359 liters	Standard Error 0.015
Ipratropium Respimat 20 mcg	FVC AUC0-4 at Day 85	0.265 liters	Standard Error 0.015

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.054, 0.135]ANCOVA

Secondary

FVC AUC0-6 at Day 1

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

Time frame: Before drug administration to 6 hours after drug administration at Day 1

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FVC AUC0-6 at Day 1	0.337 liters	Standard Error 0.015
COMBIVENT CFC-MDI 36/206 mcg	FVC AUC0-6 at Day 1	0.354 liters	Standard Error 0.015
Ipratropium Respimat 20 mcg	FVC AUC0-6 at Day 1	0.25 liters	Standard Error 0.016

p-value: 0.41795% CI: [-0.058, 0.024]ANCOVA

Secondary

FVC AUC0-6 at Day 29

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

Time frame: Before drug administration to 6 hours after drug administration at Day 29

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FVC AUC0-6 at Day 29	0.3 liters	Standard Error 0.015
COMBIVENT CFC-MDI 36/206 mcg	FVC AUC0-6 at Day 29	0.319 liters	Standard Error 0.015
Ipratropium Respimat 20 mcg	FVC AUC0-6 at Day 29	0.246 liters	Standard Error 0.015

p-value: 0.350595% CI: [-0.059, 0.021]ANCOVA

Secondary

FVC AUC0-6 at Day 57

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

Time frame: Before drug administration to 6 hours after drug administration on Day 57

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FVC AUC0-6 at Day 57	0.284 liters	Standard Error 0.015
COMBIVENT CFC-MDI 36/206 mcg	FVC AUC0-6 at Day 57	0.303 liters	Standard Error 0.015
Ipratropium Respimat 20 mcg	FVC AUC0-6 at Day 57	0.22 liters	Standard Error 0.015

p-value: 0.349995% CI: [-0.058, 0.021]ANCOVA

Secondary

FVC AUC0-6 at Day 85

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

Time frame: Before drug administration to 6 hours after drug administration on Day 85

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FVC AUC0-6 at Day 85	0.279 liters	Standard Error 0.015
COMBIVENT CFC-MDI 36/206 mcg	FVC AUC0-6 at Day 85	0.283 liters	Standard Error 0.015
Ipratropium Respimat 20 mcg	FVC AUC0-6 at Day 85	0.219 liters	Standard Error 0.015

p-value: 0.828895% CI: [-0.044, 0.035]ANCOVA

Secondary

FVC AUC4-6 at Day 1

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

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

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FVC AUC4-6 at Day 1	0.2 liters	Standard Error 0.017
COMBIVENT CFC-MDI 36/206 mcg	FVC AUC4-6 at Day 1	0.221 liters	Standard Error 0.017
Ipratropium Respimat 20 mcg	FVC AUC4-6 at Day 1	0.156 liters	Standard Error 0.018

p-value: 0.068895% CI: [-0.003, 0.09]ANCOVA

Secondary

FVC AUC4-6 at Day 29

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

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

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FVC AUC4-6 at Day 29	0.137 liters	Standard Error 0.017
COMBIVENT CFC-MDI 36/206 mcg	FVC AUC4-6 at Day 29	0.180 liters	Standard Error 0.017
Ipratropium Respimat 20 mcg	FVC AUC4-6 at Day 29	0.156 liters	Standard Error 0.017

p-value: 0.389595% CI: [-0.064, 0.025]ANCOVA

Secondary

FVC AUC4-6 at Day 57

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

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

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FVC AUC4-6 at Day 57	0.128 liters	Standard Error 0.016
COMBIVENT CFC-MDI 36/206 mcg	FVC AUC4-6 at Day 57	0.147 liters	Standard Error 0.016
Ipratropium Respimat 20 mcg	FVC AUC4-6 at Day 57	0.13 liters	Standard Error 0.017

p-value: 0.95995% CI: [-0.045, 0.042]ANCOVA

Secondary

FVC AUC4-6 at Day 85

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

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

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	FVC AUC4-6 at Day 85	0.117 liters	Standard Error 0.017
COMBIVENT CFC-MDI 36/206 mcg	FVC AUC4-6 at Day 85	0.130 liters	Standard Error 0.017
Ipratropium Respimat 20 mcg	FVC AUC4-6 at Day 85	0.124 liters	Standard Error 0.017

p-value: 0.765295% CI: [-0.053, 0.039]ANCOVA

Secondary

Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler

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.

Time frame: 12 weeks

Population: Treated set (US patients)

Arm	Measure	Value (MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	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
COMBIVENT CFC-MDI 36/206 mcg	Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler	6.150 units on a scale	Standard Error 0.046

Comparison: Difference: Respimat - MDIp-value: <0.0001ANOVA

Secondary

Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung

Time frame: 12 weeks

Population: Treated set (US patients)

Arm	Measure	Value (MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	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
COMBIVENT CFC-MDI 36/206 mcg	Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung	5.808 units on a scale	Standard Error 0.049

Comparison: Difference: Respimat - MDIp-value: <0.0001ANOVA

Secondary

Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use

Time frame: 12 weeks

Population: Treated set (US patients)

Arm	Measure	Value (MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use	6.048 units on a scale	Standard Error 0.036
COMBIVENT CFC-MDI 36/206 mcg	Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use	6.275 units on a scale	Standard Error 0.036

Comparison: Difference: Respimat - MDIp-value: <0.0001ANOVA

Secondary

Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine

Time frame: 12 weeks

Population: Treated set (US patients)

Arm	Measure	Value (MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine	5.411 units on a scale	Standard Error 0.049
COMBIVENT CFC-MDI 36/206 mcg	Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine	5.810 units on a scale	Standard Error 0.049

Comparison: Difference: Respimat - MDIp-value: <0.0001ANOVA

Secondary

Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler

Time frame: 12 weeks

Population: Treated set (US patients)

Arm	Measure	Value (MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler	5.639 units on a scale	Standard Error 0.048
COMBIVENT CFC-MDI 36/206 mcg	Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler	6.103 units on a scale	Standard Error 0.048

Comparison: Difference: Respimat - MDIp-value: <0.0001ANOVA

Secondary

Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler

Time frame: 12 weeks

Population: Treated set (US patients)

Arm	Measure	Value (MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	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
COMBIVENT CFC-MDI 36/206 mcg	Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler	6.117 units on a scale	Standard Error 0.047

Comparison: Difference: Respimat - MDIp-value: <0.0001ANOVA

Secondary

Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left

Time frame: 12 weeks

Population: Treated set (US patients)

Arm	Measure	Value (MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left	4.573 units on a scale	Standard Error 0.057
COMBIVENT CFC-MDI 36/206 mcg	Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left	6.184 units on a scale	Standard Error 0.057

Comparison: Difference: Respimat - MDIp-value: <0.0001ANOVA

Secondary

Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable

Time frame: 12 weeks

Population: Treated set (US patients)

Arm	Measure	Value (MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable	6.014 units on a scale	Standard Error 0.037
COMBIVENT CFC-MDI 36/206 mcg	Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable	6.279 units on a scale	Standard Error 0.037

Comparison: Difference: Respimat - MDIp-value: <0.0001ANOVA

Secondary

Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably

Time frame: 12 weeks

Population: Treated set (US patients)

Arm	Measure	Value (MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably	5.682 units on a scale	Standard Error 0.044
COMBIVENT CFC-MDI 36/206 mcg	Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably	6.190 units on a scale	Standard Error 0.044

Comparison: Difference: Respimat - MDIp-value: <0.0001ANOVA

Secondary

Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler

Time frame: 12 weeks

Population: Treated set (US patients)

Arm	Measure	Value (MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler	5.749 units on a scale	Standard Error 0.045
COMBIVENT CFC-MDI 36/206 mcg	Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler	6.127 units on a scale	Standard Error 0.045

Comparison: Difference: Respimat - MDIp-value: <0.0001ANOVA

Secondary

Night-time Rescue Medication Use

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)

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

Population: Full Analysis Set for Diary Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Night-time Rescue Medication Use	0.977 puffs	Standard Error 0.047
COMBIVENT CFC-MDI 36/206 mcg	Night-time Rescue Medication Use	0.977 puffs	Standard Error 0.047
Ipratropium Respimat 20 mcg	Night-time Rescue Medication Use	0.997 puffs	Standard Error 0.048

p-value: 0.994395% CI: [-0.1259, 0.125]ANCOVA

Comparison: This analysis is purely exploratory.p-value: 0.756995% CI: [-0.1463, 0.1064]ANCOVA

Secondary

Night-time Symptom Score

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

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

Population: Full Analysis Set for Diary Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Night-time Symptom Score	0.922 units on a scale	Standard Error 0.023
COMBIVENT CFC-MDI 36/206 mcg	Night-time Symptom Score	0.914 units on a scale	Standard Error 0.024
Ipratropium Respimat 20 mcg	Night-time Symptom Score	0.857 units on a scale	Standard Error 0.024

p-value: 0.80995% CI: [-0.05503, 0.0705]ANCOVA

Comparison: This analysis is purely exploratory.p-value: 0.04495% CI: [0.001746, 0.1283]ANCOVA

Secondary

Noncompartmental Parameters of Albuterol at Steady State

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).

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Noncompartmental Parameters of Albuterol at Steady State	4.09 ng*h/mL	Geometric Coefficient of Variation 74.3
COMBIVENT CFC-MDI 36/206 mcg	Noncompartmental Parameters of Albuterol at Steady State	5.52 ng*h/mL	Geometric Coefficient of Variation 61.4

Secondary

Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State

Time frame: 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.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State	128 pg*h/mL	Geometric Coefficient of Variation 55.4
COMBIVENT CFC-MDI 36/206 mcg	Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State	123 pg*h/mL	Geometric Coefficient of Variation 79.3
Ipratropium Respimat 20 mcg	Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State	115 pg*h/mL	Geometric Coefficient of Variation 50.9

Secondary

Peak FEV1 Response at Day 1

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FEV1 Response at Day 1	0.302 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	Peak FEV1 Response at Day 1	0.323 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	Peak FEV1 Response at Day 1	0.237 liters	Standard Error 0.008

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.043, 0.087]ANCOVA

Secondary

Peak FEV1 Response at Day 1

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FEV1 Response at Day 1	0.302 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	Peak FEV1 Response at Day 1	0.323 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	Peak FEV1 Response at Day 1	0.237 liters	Standard Error 0.008

p-value: 0.074395% CI: [-0.042, 0.002]ANCOVA

Secondary

Peak FEV1 Response at Day 29

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FEV1 Response at Day 29	0.302 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	Peak FEV1 Response at Day 29	0.296 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	Peak FEV1 Response at Day 29	0.237 liters	Standard Error 0.008

p-value: 0.571195% CI: [-0.015, 0.028]ANCOVA

Secondary

Peak FEV1 Response at Day 29

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FEV1 Response at Day 29	0.302 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	Peak FEV1 Response at Day 29	0.296 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	Peak FEV1 Response at Day 29	0.237 liters	Standard Error 0.008

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.044, 0.087]ANCOVA

Secondary

Peak FEV1 Response at Day 57

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FEV1 Response at Day 57	0.284 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	Peak FEV1 Response at Day 57	0.296 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	Peak FEV1 Response at Day 57	0.223 liters	Standard Error 0.008

p-value: 0.227495% CI: [-0.033, 0.008]ANCOVA

Secondary

Peak FEV1 Response at Day 57

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FEV1 Response at Day 57	0.284 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	Peak FEV1 Response at Day 57	0.296 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	Peak FEV1 Response at Day 57	0.223 liters	Standard Error 0.008

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.04, 0.081]ANCOVA

Secondary

Peak FEV1 Response at Day 85

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FEV1 Response at Day 85	0.293 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	Peak FEV1 Response at Day 85	0.290 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	Peak FEV1 Response at Day 85	0.225 liters	Standard Error 0.008

p-value: 0.806595% CI: [-0.018, 0.024]ANCOVA

Secondary

Peak FEV1 Response at Day 85

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FEV1 Response at Day 85	0.293 liters	Standard Error 0.008
COMBIVENT CFC-MDI 36/206 mcg	Peak FEV1 Response at Day 85	0.290 liters	Standard Error 0.008
Ipratropium Respimat 20 mcg	Peak FEV1 Response at Day 85	0.225 liters	Standard Error 0.008

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.047, 0.089]ANCOVA

Secondary

Peak FVC Response at Day 1

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FVC Response at Day 1	0.6 liters	Standard Error 0.017
COMBIVENT CFC-MDI 36/206 mcg	Peak FVC Response at Day 1	0.612 liters	Standard Error 0.017
Ipratropium Respimat 20 mcg	Peak FVC Response at Day 1	0.479 liters	Standard Error 0.017

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.075, 0.167]ANCOVA

Secondary

Peak FVC Response at Day 1

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FVC Response at Day 1	0.6 liters	Standard Error 0.017
COMBIVENT CFC-MDI 36/206 mcg	Peak FVC Response at Day 1	0.612 liters	Standard Error 0.017
Ipratropium Respimat 20 mcg	Peak FVC Response at Day 1	0.479 liters	Standard Error 0.017

p-value: 0.624495% CI: [-0.057, 0.034]ANCOVA

Secondary

Peak FVC Response at Day 29

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FVC Response at Day 29	0.594 liters	Standard Error 0.017
COMBIVENT CFC-MDI 36/206 mcg	Peak FVC Response at Day 29	0.591 liters	Standard Error 0.017
Ipratropium Respimat 20 mcg	Peak FVC Response at Day 29	0.465 liters	Standard Error 0.017

p-value: 0.87395% CI: [-0.041, 0.049]ANCOVA

Secondary

Peak FVC Response at Day 29

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FVC Response at Day 29	0.594 liters	Standard Error 0.017
COMBIVENT CFC-MDI 36/206 mcg	Peak FVC Response at Day 29	0.591 liters	Standard Error 0.017
Ipratropium Respimat 20 mcg	Peak FVC Response at Day 29	0.465 liters	Standard Error 0.017

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.084, 0.174]ANCOVA

Secondary

Peak FVC Response at Day 57

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FVC Response at Day 57	0.562 liters	Standard Error 0.017
COMBIVENT CFC-MDI 36/206 mcg	Peak FVC Response at Day 57	0.577 liters	Standard Error 0.017
Ipratropium Respimat 20 mcg	Peak FVC Response at Day 57	0.445 liters	Standard Error 0.017

p-value: 0.529495% CI: [-0.06, 0.031]ANCOVA

Secondary

Peak FVC Response at Day 57

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FVC Response at Day 57	0.562 liters	Standard Error 0.017
COMBIVENT CFC-MDI 36/206 mcg	Peak FVC Response at Day 57	0.577 liters	Standard Error 0.017
Ipratropium Respimat 20 mcg	Peak FVC Response at Day 57	0.445 liters	Standard Error 0.017

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.072, 0.163]ANCOVA

Secondary

Peak FVC Response at Day 85

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FVC Response at Day 85	0.575 liters	Standard Error 0.017
COMBIVENT CFC-MDI 36/206 mcg	Peak FVC Response at Day 85	0.562 liters	Standard Error 0.017
Ipratropium Respimat 20 mcg	Peak FVC Response at Day 85	0.449 liters	Standard Error 0.017

Comparison: This analysis is purely exploratory.p-value: <0.000195% CI: [0.081, 0.171]ANCOVA

Secondary

Peak FVC Response at Day 85

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Peak FVC Response at Day 85	0.575 liters	Standard Error 0.017
COMBIVENT CFC-MDI 36/206 mcg	Peak FVC Response at Day 85	0.562 liters	Standard Error 0.017
Ipratropium Respimat 20 mcg	Peak FVC Response at Day 85	0.449 liters	Standard Error 0.017

p-value: 0.56395% CI: [-0.032, 0.058]ANCOVA

Secondary

Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period

Time frame: During the 12-week on-treatment period

Population: Treated Set

Arm	Measure	Value (NUMBER)
COMBIVENT Respimat 20/100 mcg	Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period	14.81 Percentage of patients
COMBIVENT CFC-MDI 36/206 mcg	Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period	13.03 Percentage of patients
Ipratropium Respimat 20 mcg	Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period	10.35 Percentage of patients

Secondary

Physician's Global Evaluation Score on Pulmonary Function Testing Day 29

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.

Time frame: Prior to pulmonary function test on Day 29

Population: Treated Set

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Physician's Global Evaluation Score on Pulmonary Function Testing Day 29	4.936 units on a scale	Standard Error 0.041
COMBIVENT CFC-MDI 36/206 mcg	Physician's Global Evaluation Score on Pulmonary Function Testing Day 29	4.859 units on a scale	Standard Error 0.041
Ipratropium Respimat 20 mcg	Physician's Global Evaluation Score on Pulmonary Function Testing Day 29	4.99 units on a scale	Standard Error 0.041

p-value: 0.17395% CI: [-0.034, 0.187]ANCOVA

Comparison: This analysis is purely exploratory.p-value: 0.33695% CI: [-0.165, 0.056]ANCOVA

Secondary

Physician's Global Evaluation Score on Pulmonary Function Testing Day 57

Time frame: Prior to pulmonary function test on Day 57

Population: Treated Set

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Physician's Global Evaluation Score on Pulmonary Function Testing Day 57	4.971 units on a scale	Standard Error 0.045
COMBIVENT CFC-MDI 36/206 mcg	Physician's Global Evaluation Score on Pulmonary Function Testing Day 57	4.965 units on a scale	Standard Error 0.045
Ipratropium Respimat 20 mcg	Physician's Global Evaluation Score on Pulmonary Function Testing Day 57	5.04 units on a scale	Standard Error 0.046

p-value: 0.92495% CI: [-0.115, 0.127]ANCOVA

Comparison: This analysis is purely exploratory.p-value: 0.26695% CI: [-0.19, 0.053]ANCOVA

Secondary

Physician's Global Evaluation Score on Pulmonary Function Testing Day 85

Time frame: Prior to pulmonary function test on Day 85

Population: Treated Set

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Physician's Global Evaluation Score on Pulmonary Function Testing Day 85	5.115 units on a scale	Standard Error 0.048
COMBIVENT CFC-MDI 36/206 mcg	Physician's Global Evaluation Score on Pulmonary Function Testing Day 85	5.018 units on a scale	Standard Error 0.048
Ipratropium Respimat 20 mcg	Physician's Global Evaluation Score on Pulmonary Function Testing Day 85	5.097 units on a scale	Standard Error 0.048

p-value: 0.13995% CI: [-0.031, 0.225]ANCOVA

Comparison: This analysis is purely exploratory.p-value: 0.78895% CI: [-0.111, 0.146]ANCOVA

Secondary

Rating of Action of Turning Clear Base of Respimat

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

Time frame: 12 weeks

Population: Treated set (US patients)

Arm	Measure	Group	Value (NUMBER)
COMBIVENT Respimat 20/100 mcg	Rating of Action of Turning Clear Base of Respimat	Very easy	587 participants
COMBIVENT Respimat 20/100 mcg	Rating of Action of Turning Clear Base of Respimat	Easy	204 participants
COMBIVENT Respimat 20/100 mcg	Rating of Action of Turning Clear Base of Respimat	Neither easy nor difficult	40 participants
COMBIVENT Respimat 20/100 mcg	Rating of Action of Turning Clear Base of Respimat	Difficult	4 participants
COMBIVENT Respimat 20/100 mcg	Rating of Action of Turning Clear Base of Respimat	Very difficult	0 participants

Secondary

Rescue Medication Use on Pulmonary Test Day 1

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

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

Population: Treated Set

Arm	Measure	Value (NUMBER)
COMBIVENT Respimat 20/100 mcg	Rescue Medication Use on Pulmonary Test Day 1	8 patients
COMBIVENT CFC-MDI 36/206 mcg	Rescue Medication Use on Pulmonary Test Day 1	9 patients
Ipratropium Respimat 20 mcg	Rescue Medication Use on Pulmonary Test Day 1	7 patients

Secondary

Rescue Medication Use on Pulmonary Test Day 29

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

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

Population: Treated Set

Arm	Measure	Value (NUMBER)
COMBIVENT Respimat 20/100 mcg	Rescue Medication Use on Pulmonary Test Day 29	10 patients
COMBIVENT CFC-MDI 36/206 mcg	Rescue Medication Use on Pulmonary Test Day 29	7 patients
Ipratropium Respimat 20 mcg	Rescue Medication Use on Pulmonary Test Day 29	7 patients

Secondary

Rescue Medication Use on Pulmonary Test Day 57

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

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

Population: Treated Set

Arm	Measure	Value (NUMBER)
COMBIVENT Respimat 20/100 mcg	Rescue Medication Use on Pulmonary Test Day 57	7 patients
COMBIVENT CFC-MDI 36/206 mcg	Rescue Medication Use on Pulmonary Test Day 57	7 patients
Ipratropium Respimat 20 mcg	Rescue Medication Use on Pulmonary Test Day 57	6 patients

Secondary

Rescue Medication Use on Pulmonary Test Day 85

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

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

Population: Treated Set

Arm	Measure	Value (NUMBER)
COMBIVENT Respimat 20/100 mcg	Rescue Medication Use on Pulmonary Test Day 85	5 patients
COMBIVENT CFC-MDI 36/206 mcg	Rescue Medication Use on Pulmonary Test Day 85	7 patients
Ipratropium Respimat 20 mcg	Rescue Medication Use on Pulmonary Test Day 85	10 patients

Secondary

Time to Onset of Therapeutic FEV1 Response at Day 1

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (MEDIAN)
COMBIVENT Respimat 20/100 mcg	Time to Onset of Therapeutic FEV1 Response at Day 1	13 Minutes
COMBIVENT CFC-MDI 36/206 mcg	Time to Onset of Therapeutic FEV1 Response at Day 1	12 Minutes
Ipratropium Respimat 20 mcg	Time to Onset of Therapeutic FEV1 Response at Day 1	28 Minutes

Secondary

Time to Onset of Therapeutic FEV1 Response at Day 29

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (MEDIAN)
COMBIVENT Respimat 20/100 mcg	Time to Onset of Therapeutic FEV1 Response at Day 29	12 Minutes
COMBIVENT CFC-MDI 36/206 mcg	Time to Onset of Therapeutic FEV1 Response at Day 29	13 Minutes
Ipratropium Respimat 20 mcg	Time to Onset of Therapeutic FEV1 Response at Day 29	27 Minutes

Secondary

Time to Onset of Therapeutic FEV1 Response at Day 57

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (MEDIAN)
COMBIVENT Respimat 20/100 mcg	Time to Onset of Therapeutic FEV1 Response at Day 57	13 Minutes
COMBIVENT CFC-MDI 36/206 mcg	Time to Onset of Therapeutic FEV1 Response at Day 57	12 Minutes
Ipratropium Respimat 20 mcg	Time to Onset of Therapeutic FEV1 Response at Day 57	29 Minutes

Secondary

Time to Onset of Therapeutic FEV1 Response at Day 85

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (MEDIAN)
COMBIVENT Respimat 20/100 mcg	Time to Onset of Therapeutic FEV1 Response at Day 85	12 Minutes
COMBIVENT CFC-MDI 36/206 mcg	Time to Onset of Therapeutic FEV1 Response at Day 85	13 Minutes
Ipratropium Respimat 20 mcg	Time to Onset of Therapeutic FEV1 Response at Day 85	27 Minutes

Secondary

Time to Peak FEV1 Response at Day 1

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (MEDIAN)
COMBIVENT Respimat 20/100 mcg	Time to Peak FEV1 Response at Day 1	60 Minutes
COMBIVENT CFC-MDI 36/206 mcg	Time to Peak FEV1 Response at Day 1	60 Minutes
Ipratropium Respimat 20 mcg	Time to Peak FEV1 Response at Day 1	120 Minutes

Secondary

Time to Peak FEV1 Response at Day 29

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (MEDIAN)
COMBIVENT Respimat 20/100 mcg	Time to Peak FEV1 Response at Day 29	60 Minutes
COMBIVENT CFC-MDI 36/206 mcg	Time to Peak FEV1 Response at Day 29	60 Minutes
Ipratropium Respimat 20 mcg	Time to Peak FEV1 Response at Day 29	120 Minutes

Secondary

Time to Peak FEV1 Response at Day 57

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (MEDIAN)
COMBIVENT Respimat 20/100 mcg	Time to Peak FEV1 Response at Day 57	60 Minutes
COMBIVENT CFC-MDI 36/206 mcg	Time to Peak FEV1 Response at Day 57	60 Minutes
Ipratropium Respimat 20 mcg	Time to Peak FEV1 Response at Day 57	60 Minutes

Secondary

Time to Peak FEV1 Response at Day 85

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

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

Population: Full Analysis Set for Pulmonary Function Test Data

Arm	Measure	Value (MEDIAN)
COMBIVENT Respimat 20/100 mcg	Time to Peak FEV1 Response at Day 85	60 Minutes
COMBIVENT CFC-MDI 36/206 mcg	Time to Peak FEV1 Response at Day 85	60 Minutes
Ipratropium Respimat 20 mcg	Time to Peak FEV1 Response at Day 85	60 Minutes

Secondary

Trough Peak Expiratory Flow Rate (PEFR)

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

Time frame: 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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
COMBIVENT Respimat 20/100 mcg	Trough Peak Expiratory Flow Rate (PEFR)	191.95 liters/min	Standard Error 1.51
COMBIVENT CFC-MDI 36/206 mcg	Trough Peak Expiratory Flow Rate (PEFR)	190.290 liters/min	Standard Error 1.526
Ipratropium Respimat 20 mcg	Trough Peak Expiratory Flow Rate (PEFR)	189.51 liters/min	Standard Error 1.551

p-value: 0.423895% CI: [-2.3995, 5.7047]ANCOVA

Comparison: This analysis is purely exploratory.p-value: 0.243195% CI: [-1.6578, 6.533]ANCOVA

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026

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

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

FEV1 AUC0-4 at Day 85

FEV1 AUC0-6 at Day 85

FEV1 AUC4-6 at Day 85

COPD Exacerbation During the On-treatment Period

COPD Exacerbation Rate During the On-treatment Period

Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours

Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours

Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours

Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours

Daytime Rescue Medication Use

Daytime Symptom Score

Device Preference (Respimat or MDI)

Duration of Therapeutic FEV1 Response at Day 1

Duration of Therapeutic FEV1 Response at Day 29

Duration of Therapeutic FEV1 Response at Day 57

Duration of Therapeutic FEV1 Response at Day 85

FEV1 AUC0-4 at Day 1

FEV1 AUC0-4 at Day 29

FEV1 AUC0-4 at Day 57

FEV1 AUC0-6 at Day 1

FEV1 AUC0-6 at Day 29

FEV1 AUC0-6 at Day 57

FEV1 AUC4-6 at Day 1

FEV1 AUC4-6 at Day 29

FEV1 AUC4-6 at Day 57

Frequency Distribution of Satisfaction Rating With Inhaler Attributes

FVC AUC0-4 at Day 1

FVC AUC0-4 at Day 29

FVC AUC0-4 at Day 57

FVC AUC0-4 at Day 85

FVC AUC0-6 at Day 1

FVC AUC0-6 at Day 29

FVC AUC0-6 at Day 57

FVC AUC0-6 at Day 85

FVC AUC4-6 at Day 1

FVC AUC4-6 at Day 29

FVC AUC4-6 at Day 57

FVC AUC4-6 at Day 85

Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler

Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung

Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use

Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine

Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler

Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler

Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left

Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable

Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably

Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler

Night-time Rescue Medication Use

Night-time Symptom Score

Noncompartmental Parameters of Albuterol at Steady State

Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State

Peak FEV1 Response at Day 1

Peak FEV1 Response at Day 1

Peak FEV1 Response at Day 29

Peak FEV1 Response at Day 29

Peak FEV1 Response at Day 57

Peak FEV1 Response at Day 57

Peak FEV1 Response at Day 85

Peak FEV1 Response at Day 85