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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 813 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01964352
The ClinicalTrials.gov registry entry for NCT01964352 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 813 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01964352 reports 0 study locations.
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.
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