Trial Outcomes & Findings for Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease (NCT NCT01019694)
NCT ID: NCT01019694
Last Updated: 2014-10-23
Results Overview
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
470 participants
Primary outcome timeframe
48 weeks
Results posted on
2014-10-23
Participant Flow
Participant milestones
| Measure |
Combivent Respimat
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Overall Study
STARTED
|
157
|
156
|
157
|
|
Overall Study
COMPLETED
|
133
|
118
|
110
|
|
Overall Study
NOT COMPLETED
|
24
|
38
|
47
|
Reasons for withdrawal
| Measure |
Combivent Respimat
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
12
|
16
|
19
|
|
Overall Study
Protocol Violation
|
2
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
12
|
|
Overall Study
Not treated
|
0
|
2
|
3
|
|
Overall Study
Other reason (not specified)
|
1
|
5
|
6
|
Baseline Characteristics
Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=154 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=154 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
Total
n=465 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Age, Customized
>= 40 to < 65 years
|
90 participants
n=5 Participants
|
91 participants
n=7 Participants
|
82 participants
n=5 Participants
|
263 participants
n=4 Participants
|
|
Age, Customized
>= 65 to < 75 years
|
51 participants
n=5 Participants
|
47 participants
n=7 Participants
|
58 participants
n=5 Participants
|
156 participants
n=4 Participants
|
|
Age, Customized
>= 75 years
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
14 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
192 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
273 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black / African American
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
9 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
148 participants
n=5 Participants
|
143 participants
n=7 Participants
|
144 participants
n=5 Participants
|
435 participants
n=4 Participants
|
|
Height
|
170.6 centimeters
STANDARD_DEVIATION 9.6 • n=5 Participants
|
170.6 centimeters
STANDARD_DEVIATION 10.4 • n=7 Participants
|
171.1 centimeters
STANDARD_DEVIATION 10.4 • n=5 Participants
|
170.8 centimeters
STANDARD_DEVIATION 10.1 • n=4 Participants
|
|
Smoking History
Ex-smoker
|
83 participants
n=5 Participants
|
61 participants
n=7 Participants
|
79 participants
n=5 Participants
|
223 participants
n=4 Participants
|
|
Smoking History
Currently smokes
|
74 participants
n=5 Participants
|
93 participants
n=7 Participants
|
75 participants
n=5 Participants
|
242 participants
n=4 Participants
|
|
Smoking History (pack years)
|
53.6 pack years
STANDARD_DEVIATION 24.5 • n=5 Participants
|
53.6 pack years
STANDARD_DEVIATION 29.7 • n=7 Participants
|
55.6 pack years
STANDARD_DEVIATION 25.4 • n=5 Participants
|
54.3 pack years
STANDARD_DEVIATION 26.6 • n=4 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD) Duration
|
8.1 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
7.3 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
7.5 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
7.6 years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Outcome measures
| Measure |
Combivent Respimat
n=134 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=125 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=110 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48
|
87.9 unit on a scale
Standard Error 1.27
|
78.3 unit on a scale
Standard Error 1.31
|
81.7 unit on a scale
Standard Error 1.37
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Outcome measures
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=152 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=153 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3
|
84.7 unit on a scale
Standard Error 1.07
|
79.4 unit on a scale
Standard Error 1.09
|
77.3 unit on a scale
Standard Error 1.08
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Outcome measures
| Measure |
Combivent Respimat
n=149 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=149 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=146 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12
|
85.9 unit on a scale
Standard Error 1.14
|
78.0 unit on a scale
Standard Error 1.15
|
76.3 unit on a scale
Standard Error 1.16
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Outcome measures
| Measure |
Combivent Respimat
n=142 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=142 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=130 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24
|
86.6 unit on a scale
Standard Error 1.15
|
77.5 unit on a scale
Standard Error 1.16
|
78.9 unit on a scale
Standard Error 1.19
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Outcome measures
| Measure |
Combivent Respimat
n=136 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=132 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=119 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36
|
88.2 unit on a scale
Standard Error 1.22
|
76.9 unit on a scale
Standard Error 1.24
|
80.5 unit on a scale
Standard Error 1.29
|
SECONDARY outcome
Timeframe: 0 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Outcome measures
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=154 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=154 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0
|
5.8 units on a scale
Standard Deviation 1.21
|
5.9 units on a scale
Standard Deviation 1.24
|
5.8 units on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Outcome measures
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=152 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=153 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3
|
6.2 unit on a scale
Standard Error 0.08
|
6.1 unit on a scale
Standard Error 0.08
|
5.9 unit on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Outcome measures
| Measure |
Combivent Respimat
n=149 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=149 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=146 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12
|
6.2 unit on a scale
Standard Error 0.09
|
6.0 unit on a scale
Standard Error 0.09
|
5.8 unit on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Outcome measures
| Measure |
Combivent Respimat
n=142 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=142 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=130 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24
|
6.3 unit on a scale
Standard Error 0.08
|
6.0 unit on a scale
Standard Error 0.08
|
5.8 unit on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Outcome measures
| Measure |
Combivent Respimat
n=136 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=132 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=119 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36
|
6.4 unit on a scale
Standard Error 0.08
|
6.0 unit on a scale
Standard Error 0.09
|
5.9 unit on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Outcome measures
| Measure |
Combivent Respimat
n=134 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=125 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=110 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48
|
6.3 unit on a scale
Standard Error 0.09
|
6.1 unit on a scale
Standard Error 0.09
|
6.0 unit on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 0 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Outcome measures
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=153 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=154 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0
|
2.8 units on a scale
Standard Deviation 1.13
|
2.7 units on a scale
Standard Deviation 1.23
|
2.8 units on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Outcome measures
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=152 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=153 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3
|
2.7 unit on a scale
Standard Error 0.07
|
2.7 unit on a scale
Standard Error 0.07
|
2.8 unit on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Outcome measures
| Measure |
Combivent Respimat
n=150 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=149 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=146 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12
|
2.8 unit on a scale
Standard Error 0.08
|
2.9 unit on a scale
Standard Error 0.08
|
2.8 unit on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Outcome measures
| Measure |
Combivent Respimat
n=142 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=142 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=130 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24
|
2.7 unit on a scale
Standard Error 0.08
|
2.8 unit on a scale
Standard Error 0.08
|
2.8 unit on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Outcome measures
| Measure |
Combivent Respimat
n=136 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=132 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=119 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36
|
2.7 unit on a scale
Standard Error 0.09
|
2.8 unit on a scale
Standard Error 0.09
|
2.7 unit on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Outcome measures
| Measure |
Combivent Respimat
n=134 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=125 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=110 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48
|
2.8 unit on a scale
Standard Error 0.09
|
2.7 unit on a scale
Standard Error 0.09
|
2.9 unit on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 0 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Outcome measures
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=154 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=154 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Physician's Global Evaluation at Week 0
|
5.1 units on a scale
Standard Deviation 1.18
|
4.9 units on a scale
Standard Deviation 1.22
|
4.9 units on a scale
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Outcome measures
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=152 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=152 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Physician's Global Evaluation at Week 3
|
5.0 unit on a scale
Standard Error 0.07
|
5.1 unit on a scale
Standard Error 0.07
|
5.1 unit on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Outcome measures
| Measure |
Combivent Respimat
n=150 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=148 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=146 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Physician's Global Evaluation at Week 12
|
5.1 unit on a scale
Standard Error 0.08
|
5.2 unit on a scale
Standard Error 0.08
|
5.0 unit on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Outcome measures
| Measure |
Combivent Respimat
n=142 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=142 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=130 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Physician's Global Evaluation at Week 24
|
5.1 unit on a scale
Standard Error 0.08
|
5.2 unit on a scale
Standard Error 0.08
|
5.2 unit on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Outcome measures
| Measure |
Combivent Respimat
n=136 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=132 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=118 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Physician's Global Evaluation at Week 36
|
5.1 unit on a scale
Standard Error 0.09
|
5.2 unit on a scale
Standard Error 0.09
|
5.2 unit on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Outcome measures
| Measure |
Combivent Respimat
n=133 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=125 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=108 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Physician's Global Evaluation at Week 48
|
5.2 unit on a scale
Standard Error 0.09
|
5.3 unit on a scale
Standard Error 0.09
|
5.1 unit on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: baseline, day 1Population: Treated Set is defined as all patients who were randomized and received study drug
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose on test day 1.
Outcome measures
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=154 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=154 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Change From Baseline in FEV1 at Day 1
|
0.22 liters
Standard Error 0.015
|
0.21 liters
Standard Error 0.015
|
0.21 liters
Standard Error 0.015
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 12
Outcome measures
| Measure |
Combivent Respimat
n=145 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=144 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=136 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Change From Baseline in FEV1 at Week 12
|
0.23 liters
Standard Error 0.016
|
0.19 liters
Standard Error 0.016
|
0.20 liters
Standard Error 0.017
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 24
Outcome measures
| Measure |
Combivent Respimat
n=138 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=134 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=124 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Change From Baseline in FEV1 at Week 24
|
0.20 liters
Standard Error 0.016
|
0.21 liters
Standard Error 0.016
|
0.21 liters
Standard Error 0.017
|
SECONDARY outcome
Timeframe: baseline, 48 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 48
Outcome measures
| Measure |
Combivent Respimat
n=133 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=121 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=108 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Change From Baseline in FEV1 at Week 48
|
0.22 liters
Standard Error 0.019
|
0.16 liters
Standard Error 0.019
|
0.23 liters
Standard Error 0.020
|
SECONDARY outcome
Timeframe: baseline, day 1Population: Treated Set is defined as all patients who were randomized and received study drug
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose on test day 1.
Outcome measures
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=154 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=154 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Change From Baseline in FVC at Day 1
|
0.37 liters
Standard Error 0.026
|
0.34 liters
Standard Error 0.027
|
0.36 liters
Standard Error 0.027
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 12
Outcome measures
| Measure |
Combivent Respimat
n=145 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=144 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=136 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Change From Baseline in FVC at Week 12
|
0.38 liters
Standard Error 0.027
|
0.31 liters
Standard Error 0.027
|
0.35 liters
Standard Error 0.027
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 24
Outcome measures
| Measure |
Combivent Respimat
n=138 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=134 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=124 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Change From Baseline in FVC at Week 24
|
0.33 liters
Standard Error 0.030
|
0.35 liters
Standard Error 0.030
|
0.35 liters
Standard Error 0.031
|
SECONDARY outcome
Timeframe: baseline, 48 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 48
Outcome measures
| Measure |
Combivent Respimat
n=133 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=121 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=108 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Change From Baseline in FVC at Week 48
|
0.35 liters
Standard Error 0.032
|
0.30 liters
Standard Error 0.033
|
0.37 liters
Standard Error 0.034
|
SECONDARY outcome
Timeframe: 0 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 0
Outcome measures
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=153 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=154 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0
|
2.1 number of puffs
Standard Deviation 2.63
|
1.5 number of puffs
Standard Deviation 2.23
|
1.9 number of puffs
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 3
Outcome measures
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=151 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=152 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3
|
1.7 number of puffs
Standard Error 0.10
|
1.8 number of puffs
Standard Error 0.11
|
1.7 number of puffs
Standard Error 0.11
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 12
Outcome measures
| Measure |
Combivent Respimat
n=147 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=149 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=145 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12
|
1.9 number of puffs
Standard Error 0.14
|
1.9 number of puffs
Standard Error 0.14
|
1.7 number of puffs
Standard Error 0.14
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 24
Outcome measures
| Measure |
Combivent Respimat
n=142 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=143 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=129 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24
|
2.1 number of puffs
Standard Error 0.15
|
2.0 number of puffs
Standard Error 0.15
|
1.6 number of puffs
Standard Error 0.16
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 36
Outcome measures
| Measure |
Combivent Respimat
n=136 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=131 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=116 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36
|
1.9 number of puffs
Standard Error 0.15
|
2.1 number of puffs
Standard Error 0.15
|
1.8 number of puffs
Standard Error 0.16
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 48
Outcome measures
| Measure |
Combivent Respimat
n=133 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=122 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=110 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48
|
2.0 number of puffs
Standard Error 0.16
|
2.1 number of puffs
Standard Error 0.16
|
1.8 number of puffs
Standard Error 0.16
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Outcome measures
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=154 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=154 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
5 or more exacerbations
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
None
|
118 participants
118
|
113 participants
113
|
110 participants
110
|
|
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
1 exacerbation
|
27 participants
|
32 participants
|
37 participants
|
|
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
2 exacerbations
|
7 participants
|
9 participants
|
5 participants
|
|
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
3 exacerbations
|
3 participants
|
0 participants
|
2 participants
|
|
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
4 exacerbations
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Treated Set is defined as all patients who were randomized and received study drug
Outcome measures
| Measure |
Combivent Respimat
n=157 Participants
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=154 Participants
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=154 Participants
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization
None
|
147 participants
147
|
148 participants
148
|
146 participants
146
|
|
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization
1 exacerbation
|
9 participants
|
6 participants
|
8 participants
|
|
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization
2 exacerbations
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization
3 or more exacerbations
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
Combivent Respimat
Serious events: 23 serious events
Other events: 68 other events
Deaths: 0 deaths
Combivent Inhalation Aerosol
Serious events: 20 serious events
Other events: 76 other events
Deaths: 0 deaths
Atrovent + Albuterol Aerosols
Serious events: 25 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combivent Respimat
n=157 participants at risk
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=154 participants at risk
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=154 participants at risk
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Cardiac disorders
Cardiac failure congestive
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Cardiac disorders
Coronary artery disease
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
2/157 • From first drug intake until one day after last drug intake
|
1.3%
2/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Endocrine disorders
Pituitary haemorrhage
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Gastrointestinal disorders
Abdominal pain
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Gastrointestinal disorders
Anal fistula
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
General disorders
Chest pain
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
General disorders
Death
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Appendicitis
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
1.3%
2/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Appendicitis perforated
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Cellulitis
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Diabetic foot infection
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Perirectal abscess
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Pneumonia
|
2.5%
4/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Sepsis
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Septic shock
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Urosepsis
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Injury, poisoning and procedural complications
Head injury
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Investigations
Cardiac enzymes increased
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Nervous system disorders
Carotid artery stenosis
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Nervous system disorders
Headache
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Nervous system disorders
Transient ischaemic attack
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Renal and urinary disorders
Renal failure acute
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.7%
9/157 • From first drug intake until one day after last drug intake
|
2.6%
4/154 • From first drug intake until one day after last drug intake
|
4.5%
7/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
2/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.64%
1/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
|
Vascular disorders
Hypotension
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/157 • From first drug intake until one day after last drug intake
|
0.65%
1/154 • From first drug intake until one day after last drug intake
|
0.00%
0/154 • From first drug intake until one day after last drug intake
|
Other adverse events
| Measure |
Combivent Respimat
n=157 participants at risk
ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
|
Combivent Inhalation Aerosol
n=154 participants at risk
ipratropium bromide and albuterol sulfate 36/206 mcg qid
|
Atrovent + Albuterol Aerosols
n=154 participants at risk
ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
7.0%
11/157 • From first drug intake until one day after last drug intake
|
6.5%
10/154 • From first drug intake until one day after last drug intake
|
5.8%
9/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
6/157 • From first drug intake until one day after last drug intake
|
5.2%
8/154 • From first drug intake until one day after last drug intake
|
5.8%
9/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Sinusitis
|
3.8%
6/157 • From first drug intake until one day after last drug intake
|
6.5%
10/154 • From first drug intake until one day after last drug intake
|
7.1%
11/154 • From first drug intake until one day after last drug intake
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
16/157 • From first drug intake until one day after last drug intake
|
12.3%
19/154 • From first drug intake until one day after last drug intake
|
9.1%
14/154 • From first drug intake until one day after last drug intake
|
|
Psychiatric disorders
Insomnia
|
1.3%
2/157 • From first drug intake until one day after last drug intake
|
5.2%
8/154 • From first drug intake until one day after last drug intake
|
1.9%
3/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
14.6%
23/157 • From first drug intake until one day after last drug intake
|
16.9%
26/154 • From first drug intake until one day after last drug intake
|
16.9%
26/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
11/157 • From first drug intake until one day after last drug intake
|
2.6%
4/154 • From first drug intake until one day after last drug intake
|
3.9%
6/154 • From first drug intake until one day after last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
6/157 • From first drug intake until one day after last drug intake
|
5.8%
9/154 • From first drug intake until one day after last drug intake
|
6.5%
10/154 • From first drug intake until one day after last drug intake
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER