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NCT01040728 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 122
- Enrollment target
NCT01040728: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01040728 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 122 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01040728, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 122 participants
- Enrollment target
Study Summary
The study is intended to characterize the lung function profile of BI1744 in Chronic Obstructive Pulmonary Disease (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 for the first period, just prior to administration of the first morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-12h was calculated from 0-12 hour
Interventions
- DRUG Olodaterol (BI1744) Low
- DRUG Olodaterol (BI1744) High
- DRUG Tiotropium 18 mcg
- DRUG Placebo (for Olodaterol (BI1744)l)
- DRUG Placebo (for Tiotropium)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2010-01 |
| Phase | Phase 3 |
What the finished NCT01040728 record still lists
NCT01040728 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 5 interventions - of which Olodaterol (BI1744) Low is the first listed.
NCT01040728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01040728 about?
NCT01040728 is a clinical study titled "A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease". The study is intended to characterize the lung function profile of BI1744 in Chronic Obstructive Pulmonary Disease (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 treatm...
What is the current status of trial NCT01040728?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2010-01.
What interventions are being tested in trial NCT01040728?
The interventions under investigation include: Olodaterol (BI1744) Low (DRUG), Olodaterol (BI1744) High (DRUG), Tiotropium 18 mcg (DRUG), Placebo (for Olodaterol (BI1744)l) (DRUG), Placebo (for Tiotropium) (DRUG).
Who is sponsoring clinical trial NCT01040728?
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 NCT01040728's enrollment target sits among peer trials
122 1617th of 2000 higher than 382 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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