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NCT02105974 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,621
- Enrollment target
NCT02105974: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02105974 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,621 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (110% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02105974, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,621 participants
- Enrollment target
Study Summary
This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on lung function (as measured by trough forced expiratory volume in one second \[FEV1\]) of FF 100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD. ELLIPTA™ is a registered trademark of GlaxoSmithKline.
Primary Outcome
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 14, 28, 56 and 84. BL was defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosin
Interventions
- DRUG Fluticasone Furoate/Vilanterol
- DRUG Vilanterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,621 participants |
| Start Date | 2014-04-07 |
| Est. Completion | 2015-07-08 |
| Phase | Phase 3 |
What the finished NCT02105974 record still lists
NCT02105974 is an interventional study that assigns participants to a tested intervention. Its 1,621 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (110% higher).
The record links to 0 conditions, and to 2 interventions - of which Fluticasone Furoate/Vilanterol is the first listed.
NCT02105974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02105974 about?
NCT02105974 is a clinical study titled "Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary obje...
What is the current status of trial NCT02105974?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,621 participants. The study started on 2014-04-07. Estimated completion is 2015-07-08.
What interventions are being tested in trial NCT02105974?
The interventions under investigation include: Fluticasone Furoate/Vilanterol (DRUG), Vilanterol (DRUG).
Who is sponsoring clinical trial NCT02105974?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02105974's enrollment target sits among peer trials
1,621 141st of 2000 higher than 1,860 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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