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NCT01817764 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 707
- Enrollment target
NCT01817764: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01817764 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 707 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01817764, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 707 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with COPD. Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 250/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.
Primary Outcome
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Change from Baseline was calculated as the value at Day 84 minus the value at Baseline. Analysis was performed using an analysis of covariance of treatment, Baseline (mean of the t
Interventions
- DRUG Placebo
- DRUG Fluticasone propionate/salmeterol
- DRUG Umeclidinium/vilanterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 707 participants |
| Start Date | 2013-03-01 |
| Est. Completion | 2013-10-25 |
| Phase | Phase 3 |
What the finished NCT01817764 record still lists
NCT01817764 is an interventional study that assigns participants to a tested intervention. The registered 707 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01817764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01817764 about?
NCT01817764 is a clinical study titled "A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with COPD. Subjects who meet the eligibility criteria at S...
What is the current status of trial NCT01817764?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 707 participants. The study started on 2013-03-01. Estimated completion is 2013-10-25.
What interventions are being tested in trial NCT01817764?
The interventions under investigation include: Placebo (DRUG), Fluticasone propionate/salmeterol (DRUG), Umeclidinium/vilanterol (DRUG).
Who is sponsoring clinical trial NCT01817764?
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 NCT01817764's enrollment target sits among peer trials
707 505th of 2000 higher than 1,496 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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