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NCT01559116 · ClinicalTrials.gov registry record · Phase 3
Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 219
- Enrollment target
NCT01559116: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01559116 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 219 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01559116, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 219 participants
- Enrollment target
Study Summary
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.
Primary Outcome
Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 24 h post-dose, using the trapezoidal rule, divided by the duration (24 h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry
Interventions
- DRUG tiotropium + olodaterol
- DRUG tiotropium
- DRUG olodaterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
What the finished NCT01559116 record still lists
NCT01559116 is an interventional study that assigns participants to a tested intervention. The registered 219 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 (72% lower).
The record links to 0 conditions, and to 3 interventions - of which tiotropium + olodaterol is the first listed.
NCT01559116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01559116 about?
NCT01559116 is a clinical study titled "Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease". The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.
What is the current status of trial NCT01559116?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2012-03. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01559116?
The interventions under investigation include: tiotropium + olodaterol (DRUG), tiotropium (DRUG), olodaterol (DRUG).
Who is sponsoring clinical trial NCT01559116?
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 NCT01559116's enrollment target sits among peer trials
219 1329th of 2000 higher than 670 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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