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NCT00931385 · ClinicalTrials.gov registry record · Phase 3
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 99
- Enrollment target
NCT00931385: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00931385 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 99 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00931385, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 99 participants
- Enrollment target
Study Summary
The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.
Primary Outcome
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the obse
Interventions
- DRUG Placebo
- DRUG Foradil
- DRUG BI 1744
- DRUG bi1744
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2009-06 |
| Phase | Phase 3 |
What the finished NCT00931385 record still lists
NCT00931385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00931385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00931385 about?
NCT00931385 is a clinical study titled "Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease". The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.
What is the current status of trial NCT00931385?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 99 participants. The study started on 2009-06.
What interventions are being tested in trial NCT00931385?
The interventions under investigation include: Placebo (DRUG), Foradil (DRUG), BI 1744 (DRUG), bi1744 (DRUG).
Who is sponsoring clinical trial NCT00931385?
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 NCT00931385's enrollment target sits among peer trials
99 1713th of 2000 higher than 287 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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