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NCT02164513 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 10,355
- Enrollment target
- 20
- Study locations
NCT02164513 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 10,355 participants, above the 904-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (1045% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT02164513, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 10,355 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid \[ICS\]/ Long-acting Muscarinic Receptor Antagonists \[LAMA\])/ Long Acting Beta-Agonist \[LABA\] delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year. Given the clinical experience with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from their known pharmacology, the potential benefit of a new therapy option in patients with moderate to severe COPD supports the further development of the closed triple combination (delivered via one inhaler). In the current study subjects meeting all inclusion/exclusion criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety follow-up period. Eligible subjects will be randomized to one of the following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD
Conditions Studied
Interventions
- DRUG fluticasone furoate (FF)
- DRUG vilanterol (VI)
- DRUG umeclidinium bromide (UMEC)
Study Locations (20)
Alabama
- GSK Investigational Site - Athens
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Florence
- GSK Investigational Site - Jasper
- GSK Investigational Site - Mobile
- GSK Investigational Site - Muscle Shoals
- GSK Investigational Site - Sheffield
Arizona
- GSK Investigational Site - Chandler
- GSK Investigational Site - Flagstaff
- GSK Investigational Site - Glendale
- GSK Investigational Site - Peoria
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Tucson
- GSK Investigational Site - Tucson
- GSK Investigational Site - Tucson
California
- GSK Investigational Site - Arcadia
- GSK Investigational Site - Bakersfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,355 participants |
| Start Date | 2014-06-30 |
| Est. Completion | 2017-07-17 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02164513
The ClinicalTrials.gov registry entry for NCT02164513 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 10,355 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 904-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (1045% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 3 interventions - of which fluticasone furoate (FF) is the first listed.
NCT02164513 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Alabama, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT02164513 about?
NCT02164513 is a clinical study titled "A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the use of an 'open' triple thera...
What is the current status of trial NCT02164513?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 10,355 participants. The study started on 2014-06-30. Estimated completion is 2017-07-17.
What conditions does trial NCT02164513 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT02164513?
The interventions under investigation include: fluticasone furoate (FF) (DRUG), vilanterol (VI) (DRUG), umeclidinium bromide (UMEC) (DRUG).
Who is sponsoring clinical trial NCT02164513?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02164513 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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