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NCT01431287 · ClinicalTrials.gov registry record · Phase 3
Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,539
- Enrollment target
NCT01431287: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01431287 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 2,539 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (229% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01431287, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,539 participants
- Enrollment target
Study Summary
The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.
Primary Outcome
FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) inc
Interventions
- DRUG tiotropium + olodaterol
- DRUG tiotropium
- DRUG olodaterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,539 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT01431287 record still lists
NCT01431287 is an interventional study that assigns participants to a tested intervention. Its 2,539 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (229% higher).
The record links to 0 conditions, and to 3 interventions - of which tiotropium + olodaterol is the first listed.
NCT01431287 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01431287 about?
NCT01431287 is a clinical study titled "Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)". The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patien...
What is the current status of trial NCT01431287?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,539 participants. The study started on 2011-09. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01431287?
The interventions under investigation include: tiotropium + olodaterol (DRUG), tiotropium (DRUG), olodaterol (DRUG).
Who is sponsoring clinical trial NCT01431287?
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 NCT01431287's enrollment target sits among peer trials
2,539 87th of 2000 higher than 1,914 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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