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NCT01533935 · ClinicalTrials.gov registry record · Phase 3
Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 291
- Enrollment target
NCT01533935: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01533935 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 291 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01533935, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 291 participants
- Enrollment target
Study Summary
The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD.
Primary Outcome
Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model.
Interventions
- DRUG Placebo
- DRUG Tiotropium
- DRUG Olodaterol
- DRUG Tiotropium + Olodaterol
- DRUG tiotropium + Olodaterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT01533935 record still lists
NCT01533935 is an interventional study that assigns participants to a tested intervention. The registered 291 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 (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01533935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01533935 about?
NCT01533935 is a clinical study titled "Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.". The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD.
What is the current status of trial NCT01533935?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 291 participants. The study started on 2012-02. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01533935?
The interventions under investigation include: Placebo (DRUG), Tiotropium (DRUG), Olodaterol (DRUG), Tiotropium + Olodaterol (DRUG), tiotropium + Olodaterol (DRUG).
Who is sponsoring clinical trial NCT01533935?
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 NCT01533935's enrollment target sits among peer trials
291 1168th of 2000 higher than 830 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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