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NCT02006732 · ClinicalTrials.gov registry record · Phase 3
Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)
A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 809
- Enrollment target
- 20
- Study locations
NCT02006732: Completed Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
NCT02006732 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by Boehringer Ingelheim. The registered enrollment target is 809 participants, below the 1,033-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02006732, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 809 participants
- Enrollment target
- 20
- Study locations
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
Conditions Studied
Interventions
- DRUG placebo
- DRUG tiotropium
- DRUG olodaterol
Study Locations (20)
South Carolina
- 1237.26.10607 Boehringer Ingelheim Investigational Site - Gaffney
- 1237.26.10617 Boehringer Ingelheim Investigational Site - Greenville
- 1237.26.10608 Boehringer Ingelheim Investigational Site - Spartanburg
- 1237.26.10604 Boehringer Ingelheim Investigational Site - Union
Ohio
- 1237.26.10603 Boehringer Ingelheim Investigational Site - Columbus
- 1237.26.10621 Boehringer Ingelheim Investigational Site - Dayton
- 1237.26.10612 Boehringer Ingelheim Investigational Site - Toledo
Florida
- 1237.26.10619 Boehringer Ingelheim Investigational Site - Clearwater
- 1237.26.10614 Boehringer Ingelheim Investigational Site - Tampa
Texas
- 1237.26.10609 Boehringer Ingelheim Investigational Site - Boerne
- 1237.26.10602 Boehringer Ingelheim Investigational Site - San Antonio
Alabama
- 1237.26.10620 Boehringer Ingelheim Investigational Site - Jasper
Connecticut
- 1237.26.10618 Boehringer Ingelheim Investigational Site - Stamford
Georgia
- 1237.26.10616 Boehringer Ingelheim Investigational Site - Duluth
Missouri
- 1237.26.10613 Boehringer Ingelheim Investigational Site - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 809 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT02006732 record still lists
NCT02006732 is an interventional study that assigns participants to a tested intervention. The registered 809 participants enrollment target is mid-sized for trials with a published cap, below the 1,033-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT02006732 names 20 study sites across 13 states, led by South Carolina, Ohio, Florida.
Frequently Asked Questions
What is clinical trial NCT02006732 about?
NCT02006732 is a clinical study titled "Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)". 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 NCT02006732?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 809 participants. The study started on 2013-11. Estimated completion is 2014-11.
What conditions does trial NCT02006732 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT02006732?
The interventions under investigation include: placebo (DRUG), tiotropium (DRUG), olodaterol (DRUG).
Who is sponsoring clinical trial NCT02006732?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02006732 being conducted?
This trial has 20 study locations across Alabama, Connecticut, Florida, Georgia, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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participants (enrollment target), bucketed by value
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