Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 463
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Vilanterol 25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler arm 2: Vilanterol 12.5mcg inhalation powder inhaled once daily in the PM via the new powder inhaler arm 3: Vilanterol 6.25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler arm 4: Placebo inhalation powder inhaled once daily in the PM via the new powder inhaler

Interventions: intervention 1: Fluticasone propionate 100mcg intervention 2: Placebo intervention 3: Vilanterol
Intervention descriptions: intervention 1: all subjects recieve open-label Flovent twice daily duirng the run in and treatment period intervention 2: Placebo inhalation powder during treatment period intervention 3: subjects will recieve 4 weeks via NDPI during treament period

Protocol document: