Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 351
Healthy volunteers: no

Brief summary:
A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids

Detailed description:
This will be a multi-centre, randomised, placebo and active controlled (with rescue medication), double-blind, double-dummy, parallel-group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (Screening Visit) will enter a two week Run-in Period. Subjects failing screening will not be eligible for re-screening. During the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (PEF), asthma symptom scores and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised receive treatment with either fluticasone furoate 50 mcg once daily, fluticasone propionate 100 mcg twice daily or placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 6 on-treatment visits at Visits 3, 4, 5, 6, 7 and 8 (Weeks 2, 4, 8, 12, 18 and 24 respectively). Subjects will receive treatment for 24 weeks. A follow-up contact will be performed 1-week after completing study medication (Visit 9). Subjects will participate in the study for up to a maximum of 27 weeks (including screening, treatment and follow-up contact).

Arms:
arm 1: Once daily inhalation powder via Novel Dry Powder Inhaler arm 2: Twice daily inhalation powder via DISKUS/ ACCUHALER arm 3: Inhalation Powder via Novel Dry Powder Inhaler and DISKUS/ ACCUHALER

Interventions: intervention 1: Fluticasone furoate 50mcg intervention 2: Fluticasone propionate 100mcg intervention 3: Placebo
Intervention descriptions: intervention 1: Once daily inhalation powder via Novel Dry Powder Inhaler intervention 2: Twice daily inhalation powder via DISKUS/ACCUHALER intervention 3: Inhalation powder via Novel Dry Powder Inhaler and DISKUS?ACCUHALER

Protocol document: