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NCT01311661 · ClinicalTrials.gov registry record · Phase 2
A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 206
- Enrollment target
NCT01311661: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT01311661 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 206 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01311661, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 206 participants
- Enrollment target
Study Summary
This study will compare efficacy and safety of different regimens of olodaterol administration in asthma (once daily, twice daily) with placebo in a complete cross-over design each within one of the two daily dose groups (medium or high daily dose).
Primary Outcome
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.
Interventions
- DRUG Placebo twice daily
- DRUG Olodaterol low daily dose twice daily
- DRUG Olodaterol medium daily dose twice daily
- DRUG Olodaterol high daily dose once daily and placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2011-03 |
| Phase | Phase 2 |
What the finished NCT01311661 record still lists
NCT01311661 is an interventional study that assigns participants to a tested intervention. The registered 206 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 (55% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo twice daily is the first listed.
NCT01311661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01311661 about?
NCT01311661 is a clinical study titled "A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma". This study will compare efficacy and safety of different regimens of olodaterol administration in asthma (once daily, twice daily) with placebo in a complete cross-over design each within one of the two daily dose groups (medium or high daily dose).
What is the current status of trial NCT01311661?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 206 participants. The study started on 2011-03.
What interventions are being tested in trial NCT01311661?
The interventions under investigation include: Placebo twice daily (DRUG), Olodaterol low daily dose twice daily (DRUG), Olodaterol medium daily dose twice daily (DRUG), Olodaterol high daily dose once daily and placebo (DRUG).
Who is sponsoring clinical trial NCT01311661?
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 NCT01311661's enrollment target sits among peer trials
206 298th of 2000 higher than 1,703 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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