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NCT01696058 · ClinicalTrials.gov registry record · Phase 3
Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,137
- Enrollment target
NCT01696058: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01696058 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,137 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01696058, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,137 participants
- Enrollment target
Study Summary
The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.
Primary Outcome
FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12. AUC was standardized by dividing by time unit.
Interventions
- DRUG Tiotropium
- DRUG Olodaterol
- DRUG Placebo matching Olodaterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,137 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01696058 record still lists
NCT01696058 is an interventional study that assigns participants to a tested intervention. Its 1,137 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 (47% higher).
The record links to 0 conditions, and to 3 interventions - of which Tiotropium is the first listed.
NCT01696058 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01696058 about?
NCT01696058 is a clinical study titled "Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®". The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) mo...
What is the current status of trial NCT01696058?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,137 participants. The study started on 2012-09. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01696058?
The interventions under investigation include: Tiotropium (DRUG), Olodaterol (DRUG), Placebo matching Olodaterol (DRUG).
Who is sponsoring clinical trial NCT01696058?
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 NCT01696058's enrollment target sits among peer trials
1,137 243rd of 2000 higher than 1,758 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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