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NCT00818454 · ClinicalTrials.gov registry record · Phase 2
4 Week 2 Way Crossover Double Blind Treatment Phase With Combivent CFC Versus Albuterol Followed by a 4 Week Open Label Combivent Respimat When All Drugs Are Used for Symptom Relief as Needed in Pts With Moderate to Severe Asthma
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 226
- Enrollment target
NCT00818454: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT00818454 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 226 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00818454, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 226 participants
- Enrollment target
Study Summary
The primary goal of this trial is to compare the efficacy and safety of COMBIVENT CFC MDI with albuterol HFA MDI, the current standard reliever medication in asthma. In the first cross-over part of the study (Treatment Phases 1 and 2) the marketed product, COMBIVENT CFC MDI will be used. In the second, parallel group part of the trial (Treatment Phase 3) COMBIVENT RESPIMAT will be tested for acute bronchodilator efficacy in a blinded manner at the clinic visits. During the third 4-week treatment phase open label COMBIVENT RESPIMAT will be used for symptom relief as needed.
Primary Outcome
Change from baseline after 4 weeks in Forced Expiratory Volume Area Under (FEV1 AUC) the Curve from 0 to 6 hours.
Interventions
- DRUG Combivent CFC MDI
- DRUG Albuterol HFA MDI
- DRUG Respimat Combivent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2008-12 |
| Phase | Phase 2 |
What the finished NCT00818454 record still lists
NCT00818454 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% higher).
The record links to 0 conditions, and to 3 interventions - of which Combivent CFC MDI is the first listed.
NCT00818454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00818454 about?
NCT00818454 is a clinical study titled "4 Week 2 Way Crossover Double Blind Treatment Phase With Combivent CFC Versus Albuterol Followed by a 4 Week Open Label Combivent Respimat When All Drugs Are Used for Symptom Relief as Needed in Pts With Moderate to Severe Asthma". The primary goal of this trial is to compare the efficacy and safety of COMBIVENT CFC MDI with albuterol HFA MDI, the current standard reliever medication in asthma. In the first cross-over part of the study (Treatment Phases 1 and 2) the marketed product, COMBIVENT CFC MDI will be used. In the seco...
What is the current status of trial NCT00818454?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 226 participants. The study started on 2008-12.
What interventions are being tested in trial NCT00818454?
The interventions under investigation include: Combivent CFC MDI (DRUG), Albuterol HFA MDI (DRUG), Respimat Combivent (DRUG).
Who is sponsoring clinical trial NCT00818454?
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 NCT00818454's enrollment target sits among peer trials
226 267th of 2000 higher than 1,734 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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