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An Efficacy Study of Umeclidinium/Vilanterol With Tiotropium/Olodaterol in COPD Patients
NCT02799784 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to assess the effect of umeclidinium/vilanterol (UMEC/VI) versus tiotropium/olodaterol (TIO/OLO) in subjects with moderated COPD. This is a multicentre, randomized, open label, 2 period crossover complete block design study. Eligible subjects, who complete a 2-week run-in period, will be randomized to receive a sequence consisting of UMEC/VI inhalation powder (62.5/25 microgram \[mcg\] once-daily \[QD\]) administered as 1 inhalation via the ELLIPTA® Inhaler and TIO/OLO 5/5 mcg inhalation spray administered as 2 inhalations via the RESPIMAT® inhaler, for 8 weeks each. This will be followed by a 3-week washout period and one-week follow-up period. The total duration of subject participation in the study will be approximately 22 weeks. ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies. RESPIMAT is a registered trademark of Boehringer Ingelheim.
Conditions Studied
Interventions
- DRUG UMEC/VI
- DRUG TIO/OLO
- DRUG Albuterol/salbutamol
Study Locations (20)
South Carolina
- GSK Investigational Site — Charleston
- GSK Investigational Site — Greenville
- GSK Investigational Site — Spartanburg
Hesse
- GSK Investigational Site — Frankfurt am Main
- GSK Investigational Site — Frankfurt am Main
- GSK Investigational Site — Neu-Isenburg
Other
- GSK Investigational Site — Magdeburg
- GSK Investigational Site — Alicante
- GSK Investigational Site — Girona
Florida
- GSK Investigational Site — Clearwater
- GSK Investigational Site — Orlando
Saxony
- GSK Investigational Site — Dresden
- GSK Investigational Site — Leipzig
Missouri
- GSK Investigational Site — St Louis
Oregon
- GSK Investigational Site — Medford
Virginia
- GSK Investigational Site — Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2016-07-14 |
| Est. Completion | 2017-04-27 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02799784
The ClinicalTrials.gov registry entry for NCT02799784 describes a study currently listed as completed. It is categorized as Phase 4, 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 236 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 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 3 interventions — of which UMEC/VI 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: NCT02799784 reports 20 study locations spanning 12 distinct geographic areas — top geographies include South Carolina, Hesse, Other. 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 NCT02799784 about?
NCT02799784 is a clinical study titled "An Efficacy Study of Umeclidinium/Vilanterol With Tiotropium/Olodaterol in COPD Patients". The primary objective of this study is to assess the effect of umeclidinium/vilanterol (UMEC/VI) versus tiotropium/olodaterol (TIO/OLO) in subjects with moderated COPD. This is a multicentre, randomized, open label, 2 period crossover complete block design study. Eligible subjects, who complete a ...
What is the current status of trial NCT02799784?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 236 participants. The study started on 2016-07-14. Estimated completion is 2017-04-27.
What conditions does trial NCT02799784 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 NCT02799784?
The interventions under investigation include: UMEC/VI (DRUG), TIO/OLO (DRUG), Albuterol/salbutamol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02799784?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02799784 being conducted?
This trial has 20 study locations across Florida, Missouri, Oregon, South Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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