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NCT01092143 · ClinicalTrials.gov registry record · Phase 2
BI 671800 ED in Steroid-naive Asthmatic Patients
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 389
- Enrollment target
NCT01092143: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT01092143 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 389 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (192% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01092143, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 389 participants
- Enrollment target
Study Summary
This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.
Primary Outcome
Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit. MMRM in the statistical test comments is mixed effects model with repeated measures.
Interventions
- DRUG Fluticasone propionate
- DRUG BI 671800
- DRUG Fluticasone propionate placebo
- DRUG BI 671800 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 389 participants |
| Start Date | 2010-03-18 |
| Est. Completion | 2011-03-26 |
| Phase | Phase 2 |
What the finished NCT01092143 record still lists
NCT01092143 is an interventional study that assigns participants to a tested intervention. The registered 389 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 (192% higher).
The record links to 0 conditions, and to 4 interventions - of which Fluticasone propionate is the first listed.
NCT01092143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01092143 about?
NCT01092143 is a clinical study titled "BI 671800 ED in Steroid-naive Asthmatic Patients". This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.
What is the current status of trial NCT01092143?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 389 participants. The study started on 2010-03-18. Estimated completion is 2011-03-26.
What interventions are being tested in trial NCT01092143?
The interventions under investigation include: Fluticasone propionate (DRUG), BI 671800 (DRUG), Fluticasone propionate placebo (DRUG), BI 671800 Placebo (DRUG).
Who is sponsoring clinical trial NCT01092143?
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 NCT01092143's enrollment target sits among peer trials
389 108th of 2000 higher than 1,892 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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