Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
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.