Conditions: Asthma
Keywords: Fluticasone propionate asthma vilanterol GW642444 Fluticasone furoate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 587
Healthy volunteers: no

Brief summary:
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.

Detailed description:

Arms:
arm 1: Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks arm 2: Fluticasone furoate inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks arm 3: Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 24 weeks

Interventions: intervention 1: Fluticasone Furoate/Vilanterol Inhalation Powder intervention 2: Fluticasone Furoate Inhalation Powder intervention 3: Fluticasone Propionate Inhalation Powder intervention 4: Placebo Inhalation Powder 1 intervention 5: Placebo Inhalation Powder 2
Intervention descriptions: intervention 1: Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 24 weeks intervention 2: Fluticasone furoate inhalation powder inhaled orally once daily for 24 weeks intervention 3: Fluticasone propionate inhalation powder inhaled orally twice daily for 24 weeks intervention 4: Placebo in novel dry powder inhaler once daily intervention 5: Placebo in Diskus inhaler twice daily

Protocol document: