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NCT01323634 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 519
- Enrollment target
NCT01323634: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01323634 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 519 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01323634, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 519 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.
Primary Outcome
Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.
Interventions
- DRUG Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg
- DRUG Fluticasone Propionate 250mcg/ salmeterol 50mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 519 participants |
| Start Date | 2011-03-18 |
| Est. Completion | 2011-12-14 |
| Phase | Phase 3 |
What the finished NCT01323634 record still lists
NCT01323634 is an interventional study that assigns participants to a tested intervention. The registered 519 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg is the first listed.
NCT01323634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01323634 about?
NCT01323634 is a clinical study titled "Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease". The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.
What is the current status of trial NCT01323634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 519 participants. The study started on 2011-03-18. Estimated completion is 2011-12-14.
What interventions are being tested in trial NCT01323634?
The interventions under investigation include: Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg (DRUG), Fluticasone Propionate 250mcg/ salmeterol 50mcg (DRUG).
Who is sponsoring clinical trial NCT01323634?
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 NCT01323634's enrollment target sits among peer trials
519 723rd of 2000 higher than 1,278 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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