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NCT01323621 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating 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 (COPD)
A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 512
- Enrollment target
- 20
- Study locations
NCT01323621: Completed Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
NCT01323621 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 512 participants, below the 1,037-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01323621, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 512 participants
- Enrollment target
- 20
- Study locations
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), defined as the maximal amount of air that can be forcefully exhaled in one second. 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 post-dose on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change
Conditions Studied
Interventions
- DRUG Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg
- DRUG Fluticasone Propionate 250mcg / salmeterol 50mcg
- DRUG Double-dummy placebo
- DRUG Salbutamol as needed
Study Locations (20)
South Carolina
- GSK Investigational Site - Gaffney
- GSK Investigational Site - Orangeburg
- GSK Investigational Site - Seneca
- GSK Investigational Site - Spartanburg
Campania
- GSK Investigational Site - Naples
- GSK Investigational Site - San Felice A Cancello Caserta
- GSK Investigational Site - Telese Terme (BN)
Alabama
- GSK Investigational Site - Jasper
California
- GSK Investigational Site - Riverside
Florida
- GSK Investigational Site - DeLand
Idaho
- GSK Investigational Site - Coeur d'Alene
Minnesota
- GSK Investigational Site - Minneapolis
Ohio
- GSK Investigational Site - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 512 participants |
| Start Date | 2011-03-18 |
| Est. Completion | 2012-01-24 |
| Phase | Phase 3 |
What the finished NCT01323621 record still lists
NCT01323621 is an interventional study that assigns participants to a tested intervention. The registered 512 participants enrollment target is mid-sized for trials with a published cap, below the 1,037-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 4 interventions - of which Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg is the first listed.
NCT01323621 names 20 study sites across 15 states, led by South Carolina, Campania, Alabama.
Frequently Asked Questions
What is clinical trial NCT01323621 about?
NCT01323621 is a clinical study titled "Study Evaluating 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 (COPD)". 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 NCT01323621?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 512 participants. The study started on 2011-03-18. Estimated completion is 2012-01-24.
What conditions does trial NCT01323621 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT01323621?
The interventions under investigation include: Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg (DRUG), Fluticasone Propionate 250mcg / salmeterol 50mcg (DRUG), Double-dummy placebo (DRUG), Salbutamol as needed (DRUG).
Who is sponsoring clinical trial NCT01323621?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01323621 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Idaho, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01323621's enrollment target sits among peer trials
512 29th of 74 higher than 46 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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