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NCT01525615 · ClinicalTrials.gov registry record · Phase 3
A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Rate Cycle Ergometry Test in COPD
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 404
- Enrollment target
NCT01525615: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01525615 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 404 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01525615, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 404 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.
Primary Outcome
Primary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to
Interventions
- DEVICE Respimat inhaler
- DRUG tiotropium+olodaterol (low dose)
- DRUG tiotropium + olodaterol (high dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 404 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
What the finished NCT01525615 record still lists
NCT01525615 is an interventional study that assigns participants to a tested intervention. The registered 404 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 (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Respimat inhaler is the first listed.
NCT01525615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01525615 about?
NCT01525615 is a clinical study titled "A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Rate Cycle Ergometry Test in COPD". The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.
What is the current status of trial NCT01525615?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 404 participants. The study started on 2012-02. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01525615?
The interventions under investigation include: Respimat inhaler (DEVICE), tiotropium+olodaterol (low dose) (DRUG), tiotropium + olodaterol (high dose) (DRUG).
Who is sponsoring clinical trial NCT01525615?
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 NCT01525615's enrollment target sits among peer trials
404 914th of 2000 higher than 1,084 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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