Trial · NCT00400153

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

NCT00400153, Phase 3, Completed, Boehringer Ingelheim; results first posted 2009-06-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD). Trials, record NCT00400153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00400153

On this page

Trial

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

Title: Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)
NCT number: NCT00400153
Status: Completed
Phases: Phase 3
Enrollment: 1,480 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Pulmonary Disease, Chronic Obstructive
Interventions: Atrovent Respimat (20 mcg), COMBIVENT MDI (36/206 mcg), Combivent Respimat (20 mcg/100 mcg), Placebo via corresponding inhaler for blinding purposes
First posted: 2006-11-16
Last updated: 2014-06-13
Results first posted: 2009-06-01
Limitations and caveats: The FEV1 and FVC measurements at each observation time point were used to derive the primary and secondary efficacy endpoints and are not reported here. All statistical analyses for secondary endpoints are exploratory and the p-values are nominal.

Source ClinicalTrials.gov

Registered outcomes78

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

List	Outcome	Time frame	Description
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

1 to 10 of 78Source ClinicalTrials.gov

See all 78 registered outcomes

Outcomes86

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	FEV1 AUC0-6 at Day 85	Before drug administration to 6 hours after drug administration on Day 85	Full Analysis Set for Pulmonary Function Test Data	liters	LEAST_SQUARES_MEAN
PRIMARY	FEV1 AUC0-4 at Day 85	Before drug administration to 4 hours after drug administration on Day 85	Full Analysis Set for Pulmonary Function Test Data	liters	LEAST_SQUARES_MEAN
PRIMARY	FEV1 AUC4-6 at Day 85	Between 4 hours and 6 hours after drug administration on Day 85	Full Analysis Set for Pulmonary Function Test Data 4-6 hours	liters	LEAST_SQUARES_MEAN
SECONDARY	FEV1 AUC0-6 at Day 1	Before drug administration to 6 hours after drug administration on Day 1	Full Analysis Set for Pulmonary Function Test Data	liters	LEAST_SQUARES_MEAN
SECONDARY	FEV1 AUC0-6 at Day 29	Before drug administration to 6 hours after drug administration on Day 29	Full Analysis Set for Pulmonary Function Test Data	liters	LEAST_SQUARES_MEAN
SECONDARY	FEV1 AUC0-6 at Day 57	Before drug administration to 6 hours after drug administration on Day 57	Full Analysis Set for Pulmonary Function Test Data	liters	LEAST_SQUARES_MEAN
SECONDARY	FEV1 AUC0-4 at Day 1	Before drug administration to 4 hours after drug administration on Day 1	Full Analysis Set for Pulmonary Function Test Data	liters	LEAST_SQUARES_MEAN
SECONDARY	FEV1 AUC0-4 at Day 29	Before drug administration to 4 hours after drug administration on Day 29	Full Analysis Set for Pulmonary Function Test Data	liters	LEAST_SQUARES_MEAN
SECONDARY	FEV1 AUC0-4 at Day 57	Before drug administration to 4 hours after drug administration on Day 57	Full Analysis Set for Pulmonary Function Test Data	liters	LEAST_SQUARES_MEAN
SECONDARY	FEV1 AUC4-6 at Day 1	Between 4 hours and 6 hours after drug administration on Day 1	Full Analysis Set for Pulmonary Function Test Data 4-6 hours	liters	LEAST_SQUARES_MEAN

1 to 10 of 86Source ClinicalTrials.gov

See all 86 outcomes

Results by group258

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

Outcome	Group	Value	Spread	Units
FEV1 AUC0-6 at Day 85	COMBIVENT Respimat 20/100 mcg	0.145	Standard Error 0.007	liters
FEV1 AUC0-6 at Day 85	COMBIVENT CFC-MDI 36/206 mcg	0.149	Standard Error 0.007	liters
FEV1 AUC0-6 at Day 85	Ipratropium Respimat 20 mcg	0.119	Standard Error 0.007	liters
FEV1 AUC0-4 at Day 85	COMBIVENT Respimat 20/100 mcg	0.189	Standard Error 0.007	liters
FEV1 AUC0-4 at Day 85	COMBIVENT CFC-MDI 36/206 mcg	0.190	Standard Error 0.007	liters
FEV1 AUC0-4 at Day 85	Ipratropium Respimat 20 mcg	0.142	Standard Error 0.007	liters
FEV1 AUC4-6 at Day 85	COMBIVENT Respimat 20/100 mcg	0.056	Standard Error 0.008	liters
FEV1 AUC4-6 at Day 85	COMBIVENT CFC-MDI 36/206 mcg	0.066	Standard Error 0.008	liters
FEV1 AUC4-6 at Day 85	Ipratropium Respimat 20 mcg	0.073	Standard Error 0.008	liters
FEV1 AUC0-6 at Day 1	COMBIVENT Respimat 20/100 mcg	0.173	Standard Error 0.008	liters

1 to 10 of 258Source ClinicalTrials.gov

See all 258 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 20/100 mcg	486
Overall Study	STARTED	COMBIVENT CFC-MDI 36/206 mcg	491
Overall Study	STARTED	Ipratropium Respimat 20 mcg	483
Overall Study	COMPLETED	COMBIVENT Respimat 20/100 mcg	438
Overall Study	COMPLETED	COMBIVENT CFC-MDI 36/206 mcg	436
Overall Study	COMPLETED	Ipratropium Respimat 20 mcg	422
Overall Study	NOT COMPLETED	COMBIVENT Respimat 20/100 mcg	48
Overall Study	NOT COMPLETED	COMBIVENT CFC-MDI 36/206 mcg	55
Overall Study	NOT COMPLETED	Ipratropium Respimat 20 mcg	61

Source ClinicalTrials.gov

Adverse events147

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	Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	COMBIVENT Respimat 20/100 mcg	61	486
other	Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	COMBIVENT CFC-MDI 36/206 mcg	51	491
other	Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Ipratropium Respimat 20 mcg	43	483
serious	Arteriosclerosis coronary artery	Cardiac disorders	COMBIVENT Respimat 20/100 mcg	0	486
serious	Arteriosclerosis coronary artery	Cardiac disorders	COMBIVENT CFC-MDI 36/206 mcg	1	491
serious	Arteriosclerosis coronary artery	Cardiac disorders	Ipratropium Respimat 20 mcg	0	483
serious	Atrial Fibrillation	Cardiac disorders	COMBIVENT Respimat 20/100 mcg	0	486
serious	Atrial Fibrillation	Cardiac disorders	COMBIVENT CFC-MDI 36/206 mcg	1	491
serious	Atrial Fibrillation	Cardiac disorders	Ipratropium Respimat 20 mcg	0	483
serious	Coronary artery disease	Cardiac disorders	COMBIVENT Respimat 20/100 mcg	1	486

1 to 10 of 147Source ClinicalTrials.gov

See all 147 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	COMBIVENT Respimat 20/100 mcg
Total, all-cause mortality	COMBIVENT CFC-MDI 36/206 mcg
Total, all-cause mortality	Ipratropium Respimat 20 mcg
Total, other adverse events	COMBIVENT Respimat 20/100 mcg	61
Total, other adverse events	COMBIVENT CFC-MDI 36/206 mcg	51
Total, other adverse events	Ipratropium Respimat 20 mcg	43
Total, serious adverse events	COMBIVENT Respimat 20/100 mcg	17
Total, serious adverse events	COMBIVENT CFC-MDI 36/206 mcg	33
Total, serious adverse events	Ipratropium Respimat 20 mcg	14

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20172704	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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00400153

GET https://conductscience.org/api/trials/v1/NCT00400153/registered?page=2

API reference For AI assistants