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NCT01134042 · ClinicalTrials.gov registry record · Phase 3
Study HZA106829: 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
- 587
- Enrollment target
NCT01134042: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01134042 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 587 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01134042, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 587 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 each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.
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. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement 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 (BL) through Week 24 clinic visits. The highest of 3 technically acceptable measurements was record
Interventions
- DRUG Fluticasone Furoate/Vilanterol Inhalation Powder
- DRUG Fluticasone Furoate Inhalation Powder
- DRUG Fluticasone Propionate Inhalation Powder
- OTHER Placebo Inhalation Powder 1
- OTHER Placebo Inhalation Powder 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 587 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
What the finished NCT01134042 record still lists
NCT01134042 is an interventional study that assigns participants to a tested intervention. The registered 587 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 (24% lower).
The record links to 0 conditions, and to 5 interventions - of which Fluticasone Furoate/Vilanterol Inhalation Powder is the first listed.
NCT01134042 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01134042 about?
NCT01134042 is a clinical study titled "Study HZA106829: 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 administered once daily each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age an...
What is the current status of trial NCT01134042?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 587 participants. The study started on 2010-06. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01134042?
The interventions under investigation include: Fluticasone Furoate/Vilanterol Inhalation Powder (DRUG), Fluticasone Furoate Inhalation Powder (DRUG), Fluticasone Propionate Inhalation Powder (DRUG), Placebo Inhalation Powder 1 (OTHER), Placebo Inhalation Powder 2 (OTHER).
Who is sponsoring clinical trial NCT01134042?
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 NCT01134042's enrollment target sits among peer trials
587 645th of 2000 higher than 1,354 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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