Trial · NCT01019694

Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease

NCT01019694, Phase 3, Completed, Boehringer Ingelheim; results first posted 2012-05-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease. Trials, record NCT01019694. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01019694

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease
NCT number: NCT01019694
Status: Completed
Phases: Phase 3
Enrollment: 470 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Pulmonary Disease, Chronic Obstructive
Interventions: Combivent CFC-MDI, Combivent Respimat 20/100 mcg, Atrovent HFA 42 mcg + Albuterol HFA 200 mcg
First posted: 2009-11-25
Last updated: 2014-10-23
Results first posted: 2012-05-01

Source ClinicalTrials.gov

Registered outcomes39

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48	48 weeks	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).
Secondary	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3	3 weeks	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).
Secondary	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12	12 weeks	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).
Secondary	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24	24 weeks	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).
Secondary	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36	36 weeks	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).
Secondary	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0	0 weeks	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).
Secondary	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3	3 weeks	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).
Secondary	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12	12 weeks	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).
Secondary	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24	24 weeks	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).
Secondary	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36	36 weeks	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).

1 to 10 of 39Source ClinicalTrials.gov

See all 39 registered outcomes

Outcomes39

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48	48 weeks	Treated Set is defined as all patients who were randomized and received study drug	unit on a scale	LEAST_SQUARES_MEAN
SECONDARY	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3	3 weeks	Treated Set is defined as all patients who were randomized and received study drug	unit on a scale	LEAST_SQUARES_MEAN
SECONDARY	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12	12 weeks	Treated Set is defined as all patients who were randomized and received study drug	unit on a scale	LEAST_SQUARES_MEAN
SECONDARY	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24	24 weeks	Treated Set is defined as all patients who were randomized and received study drug	unit on a scale	LEAST_SQUARES_MEAN
SECONDARY	Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36	36 weeks	Treated Set is defined as all patients who were randomized and received study drug	unit on a scale	LEAST_SQUARES_MEAN
SECONDARY	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0	0 weeks	Treated Set is defined as all patients who were randomized and received study drug	units on a scale	MEAN
SECONDARY	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3	3 weeks	Treated Set is defined as all patients who were randomized and received study drug	unit on a scale	LEAST_SQUARES_MEAN
SECONDARY	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12	12 weeks	Treated Set is defined as all patients who were randomized and received study drug	unit on a scale	LEAST_SQUARES_MEAN
SECONDARY	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24	24 weeks	Treated Set is defined as all patients who were randomized and received study drug	unit on a scale	LEAST_SQUARES_MEAN
SECONDARY	Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36	36 weeks	Treated Set is defined as all patients who were randomized and received study drug	unit on a scale	LEAST_SQUARES_MEAN

1 to 10 of 39Source ClinicalTrials.gov

See all 39 outcomes

Results by group141

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48	Combivent Respimat	87.9	Standard Error 1.27	unit on a scale
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48	Combivent Inhalation Aerosol	78.3	Standard Error 1.31	unit on a scale
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48	Atrovent + Albuterol Aerosols	81.7	Standard Error 1.37	unit on a scale
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3	Combivent Respimat	84.7	Standard Error 1.07	unit on a scale
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3	Combivent Inhalation Aerosol	79.4	Standard Error 1.09	unit on a scale
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3	Atrovent + Albuterol Aerosols	77.3	Standard Error 1.08	unit on a scale
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12	Combivent Respimat	85.9	Standard Error 1.14	unit on a scale
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12	Combivent Inhalation Aerosol	78.0	Standard Error 1.15	unit on a scale
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12	Atrovent + Albuterol Aerosols	76.3	Standard Error 1.16	unit on a scale
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24	Combivent Respimat	86.6	Standard Error 1.15	unit on a scale

1 to 10 of 141Source ClinicalTrials.gov

See all 141 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Combivent Respimat	157
Overall Study	STARTED	Combivent Inhalation Aerosol	156
Overall Study	STARTED	Atrovent + Albuterol Aerosols	157
Overall Study	COMPLETED	Combivent Respimat	133
Overall Study	COMPLETED	Combivent Inhalation Aerosol	118
Overall Study	COMPLETED	Atrovent + Albuterol Aerosols	110
Overall Study	NOT COMPLETED	Combivent Respimat	24
Overall Study	NOT COMPLETED	Combivent Inhalation Aerosol	38
Overall Study	NOT COMPLETED	Atrovent + Albuterol Aerosols	47

Source ClinicalTrials.gov

Adverse events255

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Bronchitis	Infections and infestations	Combivent Respimat	11	157
other	Bronchitis	Infections and infestations	Combivent Inhalation Aerosol	10	154
other	Bronchitis	Infections and infestations	Atrovent + Albuterol Aerosols	9	154
other	Nasopharyngitis	Infections and infestations	Combivent Respimat	6	157
other	Nasopharyngitis	Infections and infestations	Combivent Inhalation Aerosol	8	154
other	Nasopharyngitis	Infections and infestations	Atrovent + Albuterol Aerosols	9	154
other	Sinusitis	Infections and infestations	Combivent Respimat	6	157
other	Sinusitis	Infections and infestations	Combivent Inhalation Aerosol	10	154
other	Sinusitis	Infections and infestations	Atrovent + Albuterol Aerosols	11	154
other	Upper respiratory tract infection	Infections and infestations	Combivent Respimat	16	157

1 to 10 of 255Source ClinicalTrials.gov

See all 255 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Combivent Respimat
Total, all-cause mortality	Combivent Inhalation Aerosol
Total, all-cause mortality	Atrovent + Albuterol Aerosols
Total, other adverse events	Combivent Respimat	68	157
Total, other adverse events	Combivent Inhalation Aerosol	76	154
Total, other adverse events	Atrovent + Albuterol Aerosols	71	154
Total, serious adverse events	Combivent Respimat	23	157
Total, serious adverse events	Combivent Inhalation Aerosol	20	154
Total, serious adverse events	Atrovent + Albuterol Aerosols	25	154

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23658479	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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