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NCT00400153 · ClinicalTrials.gov registry record · Phase 3
Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,480
- Enrollment target
NCT00400153: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00400153 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,480 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00400153, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,480 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Atrovent Respimat (20 mcg)
- DRUG COMBIVENT MDI (36/206 mcg)
- DRUG Combivent Respimat (20 mcg/100 mcg)
- DRUG Placebo via corresponding inhaler for blinding purposes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,480 participants |
| Start Date | 2006-11 |
| Phase | Phase 3 |
What the finished NCT00400153 record still lists
NCT00400153 is an interventional study that assigns participants to a tested intervention. Its 1,480 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% higher).
The record links to 0 conditions, and to 4 interventions - of which Atrovent Respimat (20 mcg) is the first listed.
NCT00400153 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00400153 about?
NCT00400153 is a clinical study titled "Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)". 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...
What is the current status of trial NCT00400153?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,480 participants. The study started on 2006-11.
What interventions are being tested in trial NCT00400153?
The interventions under investigation include: Atrovent Respimat (20 mcg) (DRUG), COMBIVENT MDI (36/206 mcg) (DRUG), Combivent Respimat (20 mcg/100 mcg) (DRUG), Placebo via corresponding inhaler for blinding purposes (DRUG).
Who is sponsoring clinical trial NCT00400153?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00400153's enrollment target sits among peer trials
1,480 163rd of 2000 higher than 1,838 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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