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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,480 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00400153
The ClinicalTrials.gov registry entry for NCT00400153 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Atrovent Respimat (20 mcg) is the first listed.
NCT00400153 reports 0 study locations.
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.
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