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NCT01147848 · ClinicalTrials.gov registry record · Phase 3
HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 810
- Enrollment target
NCT01147848: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01147848 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 810 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
NCT01147848, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 810 participants
- Enrollment target
Study Summary
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.
Primary Outcome
Pulmonary function was measured by 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 post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, on Day 168/Week 24. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the p
Interventions
- DRUG Fluticasone furoate/Vilanterol Inhalation Powder
- DRUG Fluticasone propionate/salmeterol Inhalation Powder
- DRUG Placebo (1)
- DRUG Placebo (2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 810 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT01147848 record still lists
NCT01147848 is an interventional study that assigns participants to a tested intervention. The registered 810 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 4 interventions - of which Fluticasone furoate/Vilanterol Inhalation Powder is the first listed.
NCT01147848 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01147848 about?
NCT01147848 is a clinical study titled "HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents". The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial a...
What is the current status of trial NCT01147848?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 810 participants. The study started on 2010-06. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01147848?
The interventions under investigation include: Fluticasone furoate/Vilanterol Inhalation Powder (DRUG), Fluticasone propionate/salmeterol Inhalation Powder (DRUG), Placebo (1) (DRUG), Placebo (2) (DRUG).
Who is sponsoring clinical trial NCT01147848?
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 NCT01147848's enrollment target sits among peer trials
810 409th of 2000 higher than 1,591 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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