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Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.
NCT02296138 · View on ClinicalTrials.gov ↗
Study Summary
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.
Conditions Studied
Interventions
- DRUG tiotropium
- DRUG olodaterol
Study Locations (20)
Florida
- 1237.19.10029 Boehringer Ingelheim Investigational Site — Clearwater
- 1237.19.10106 Boehringer Ingelheim Investigational Site — Clearwater
- 1237.19.10020 Boehringer Ingelheim Investigational Site — Orlando
- 1237.19.10000 Boehringer Ingelheim Investigational Site — St. Petersburg
- 1237.19.10135 Boehringer Ingelheim Investigational Site — St. Petersburg
- 1237.19.10145 Boehringer Ingelheim Investigational Site — Tamarac
- 1237.19.10066 Boehringer Ingelheim Investigational Site — Tampa
Alabama
- 1237.19.10039 Boehringer Ingelheim Investigational Site — Andalusia
- 1237.19.10009 Boehringer Ingelheim Investigational Site — Birmingham
- 1237.19.10077 Boehringer Ingelheim Investigational Site — Florence
- 1237.19.10115 Boehringer Ingelheim Investigational Site — Jasper
California
- 1237.19.10110 Boehringer Ingelheim Investigational Site — Lincoln
- 1237.19.10118 Boehringer Ingelheim Investigational Site — Los Angeles
- 1237.19.10074 Boehringer Ingelheim Investigational Site — Poway
Arizona
- 1237.19.10069 Boehringer Ingelheim Investigational Site — Flagstaff
- 1237.19.10085 Boehringer Ingelheim Investigational Site — Peoria
Colorado
- 1237.19.10157 Boehringer Ingelheim Investigational Site — Lafayette
- 1237.19.10142 Boehringer Ingelheim Investigational Site — Wheat Ridge
Connecticut
- 1237.19.10133 Boehringer Ingelheim Investigational Site — Norwalk
- 1237.19.10093 Boehringer Ingelheim Investigational Site — Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,903 participants |
| Start Date | 2015-01-13 |
| Est. Completion | 2017-03-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02296138
The ClinicalTrials.gov registry entry for NCT02296138 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 7,903 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 2 interventions — of which tiotropium is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02296138 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02296138 about?
NCT02296138 is a clinical study titled "Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.". The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.
What is the current status of trial NCT02296138?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,903 participants. The study started on 2015-01-13. Estimated completion is 2017-03-29.
What conditions does trial NCT02296138 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02296138?
The interventions under investigation include: tiotropium (DRUG), olodaterol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02296138?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02296138 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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