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NCT01573767 · ClinicalTrials.gov registry record · Phase 2
Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 463
- Enrollment target
NCT01573767: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01573767 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 463 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (248% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01573767, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 463 participants
- Enrollment target
Study Summary
This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group, placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects entering the run-in period will stop their current asthma medication and be given open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and salbutamol/albuterol as required to use throughout the run-in and double-blind treatment period. At Visit 3 subjects meeting the randomization eligibility criteria will receive vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI) once daily for 4 weeks in addition to open-label fluticasone propionate twice daily throughout the treatment period. Primary endpoints consist of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period in all subjects. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at specific time intervals relative to the dose of study drug.
Primary Outcome
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use each morning. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 4-week Treatment Period minus the Baseline value. The Ba
Interventions
- DRUG Placebo
- DRUG Fluticasone propionate 100mcg
- DRUG Vilanterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 463 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT01573767 record still lists
NCT01573767 is an interventional study that assigns participants to a tested intervention. The registered 463 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (248% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01573767 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01573767 about?
NCT01573767 is a clinical study titled "Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children". This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group, placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects entering the run-in period will stop their current asthma medication and be given open label fluticasone propionate (FP) 100...
What is the current status of trial NCT01573767?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 463 participants. The study started on 2012-04. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01573767?
The interventions under investigation include: Placebo (DRUG), Fluticasone propionate 100mcg (DRUG), Vilanterol (DRUG).
Who is sponsoring clinical trial NCT01573767?
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 NCT01573767's enrollment target sits among peer trials
463 82nd of 2000 higher than 1,919 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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