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NCT02164539 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component
A Phase 2 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 338
- Enrollment target
- 20
- Study locations
NCT02164539: Completed Phase 2 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
NCT02164539 is a Phase 2 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 338 participants, below the 1,039-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02164539, a Phase 2 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 338 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide in combination with fluticasone furoate compared with fluticasone furoate monotherapy in chronic obstructive pulmonary disease participants with an asthmatic component. The fluticasone furoate/umeclidinium bromide treatments will also be compared to the once-daily inhaled corticosteroid/long-acting beta agonist combination fluticasone furoate/vilanterol.
Primary Outcome
FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Change from Baseline in trough FEV1 is defined as the difference in the value obtained at Visit 6 (24 hours post-dose on Visit 5) and the last acceptable/borderline acceptable value obtained prior to randomization (from Visit 2 pre-bronchodilator or Visit 3 pre-dose). Trough FEV1 is defined as the acceptable/borderline acceptable FEV1 va
Conditions Studied
Interventions
- DRUG FF
- DRUG UMEC
- DRUG VI
Study Locations (20)
South Carolina
- GSK Investigational Site - Gaffney
- GSK Investigational Site - Greenville
- GSK Investigational Site - Rock Hill
- GSK Investigational Site - Spartanburg
- GSK Investigational Site - Union
California
- GSK Investigational Site - Newport Beach
- GSK Investigational Site - San Diego
- GSK Investigational Site - Upland
Other
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Mendoza
Louisiana
- GSK Investigational Site - Sunset
Minnesota
- GSK Investigational Site - Minneapolis
North Carolina
- GSK Investigational Site - Charlotte
Ohio
- GSK Investigational Site - Cincinnati
Oregon
- GSK Investigational Site - Medford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2014-07-01 |
| Est. Completion | 2015-07-18 |
| Phase | Phase 2 |
What the finished NCT02164539 record still lists
NCT02164539 is an interventional study that assigns participants to a tested intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, below the 1,039-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 3 interventions - of which FF is the first listed.
NCT02164539 names 20 study sites across 13 states, led by South Carolina, California, Other.
Frequently Asked Questions
What is clinical trial NCT02164539 about?
NCT02164539 is a clinical study titled "Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component". The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide in combination with fluticasone furoate compared with fluticasone furoate monotherapy in chronic obstructive pulmonary disease participants with an asthmatic component. The fluticasone furoate/umeclidinium ...
What is the current status of trial NCT02164539?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 338 participants. The study started on 2014-07-01. Estimated completion is 2015-07-18.
What conditions does trial NCT02164539 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT02164539?
The interventions under investigation include: FF (DRUG), UMEC (DRUG), VI (DRUG).
Who is sponsoring clinical trial NCT02164539?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02164539 being conducted?
This trial has 20 study locations across California, Louisiana, Minnesota, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02164539's enrollment target sits among peer trials
338 33rd of 74 higher than 42 of 74 other Pulmonary Disease, Chronic Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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