Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01573767

Run by

GlaxoSmithKline

People needed

463

Starts

2012-04-01

Expected to finish

2014-04-01

Last updated by the study team

2017-01-09

Who can join

Age: 5 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent from at least one parent/ legal guardian to take part in the study.:
• Diagnosis of asthma
• pre-bronchodilator PEF between ≥50% to ≤90% of their best post-bronchodilator value
• Receiving stable asthma therapy of short acting beta-agonist (SABA) plus ICS (total daily dose FP 200mcg or equivalent)

You may not qualify if…

• history of life-threatening asthma
• history of asthma exacerbation for asthma within 6 months prior to screening.
• Culture-documented or suspected bacterial or viral infection
• significant abnormality or medical condition
• Present use of any tobacco products

Where it is running

• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Mission Viejo, California, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — Orange, California, United States
• GSK Investigational Site — Rolling Hills Estates, California, United States
• GSK Investigational Site — Aventura, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Columbus, Georgia, United States
• GSK Investigational Site — Savannah, Georgia, United States
• GSK Investigational Site — Normal, Illinois, United States
• GSK Investigational Site — Shiloh, Illinois, United States
• GSK Investigational Site — Lenexa, Kansas, United States
• GSK Investigational Site — Nicholasville, Kentucky, United States
• GSK Investigational Site — White Marsh, Maryland, United States
• GSK Investigational Site — Columbia, Missouri, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Dayton, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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