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NCT01165138 · ClinicalTrials.gov registry record · Phase 3
Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 612
- Enrollment target
NCT01165138: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01165138 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 612 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01165138, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 612 participants
- Enrollment target
Study Summary
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.
Primary Outcome
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1measurement taken at the clinic visit while still on-treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Bas
Interventions
- DRUG Fluticasone Furoate Inhalation Powder
- DRUG Fluticasone furoate/Vilanterol Inhalation Powder
- DRUG Placebo Inhaltion Powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 612 participants |
| Start Date | 2010-08-20 |
| Est. Completion | 2011-10-19 |
| Phase | Phase 3 |
What the finished NCT01165138 record still lists
NCT01165138 is an interventional study that assigns participants to a tested intervention. The registered 612 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 (21% lower).
The record links to 0 conditions, and to 3 interventions - of which Fluticasone Furoate Inhalation Powder is the first listed.
NCT01165138 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01165138 about?
NCT01165138 is a clinical study titled "Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics". The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 w...
What is the current status of trial NCT01165138?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 612 participants. The study started on 2010-08-20. Estimated completion is 2011-10-19.
What interventions are being tested in trial NCT01165138?
The interventions under investigation include: Fluticasone Furoate Inhalation Powder (DRUG), Fluticasone furoate/Vilanterol Inhalation Powder (DRUG), Placebo Inhaltion Powder (DRUG).
Who is sponsoring clinical trial NCT01165138?
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 NCT01165138's enrollment target sits among peer trials
612 598th of 2000 higher than 1,401 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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