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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 463 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01573767
The ClinicalTrials.gov registry entry for NCT01573767 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 463 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01573767 reports 0 study locations.
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.
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