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NCT01964352 · ClinicalTrials.gov registry record · Phase 3
Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 813
- Enrollment target
NCT01964352: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01964352 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 813 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01964352, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 813 participants
- Enrollment target
Study Summary
The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.
Primary Outcome
Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day inter
Interventions
- DRUG placebo
- DRUG tiotropium
- DRUG olodaterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 813 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT01964352 record still lists
NCT01964352 is an interventional study that assigns participants to a tested intervention. The registered 813 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01964352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01964352 about?
NCT01964352 is a clinical study titled "Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)". The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.
What is the current status of trial NCT01964352?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 813 participants. The study started on 2013-11. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01964352?
The interventions under investigation include: placebo (DRUG), tiotropium (DRUG), olodaterol (DRUG).
Who is sponsoring clinical trial NCT01964352?
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 NCT01964352's enrollment target sits among peer trials
813 407th of 2000 higher than 1,593 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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