Conditions: Asthma
Keywords: HPA axis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 185
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the effect of six weeks' treatment with two once-daily strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system

Detailed description:

Arms:
arm 1: Fluticasone furoate/GW642444 Dose B inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study arm 2: Fluticasone furoate/GW642444 Dose A inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study arm 3: Placebo inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study arm 4: Placebo inhalation powder once daily for 6 weeks' treatment + 1 oral prednisolone 10mg capsule each day on the last 7 days of the study

Interventions: intervention 1: Placebo Inhalation Powder intervention 2: Fluticasone Furoate/GW642444 Inhalation Powder intervention 3: Fluticasone Furoate/GW642444 Inhalation Powder intervention 4: Placebo Oral Capsule intervention 5: Prednisolone Oral Capsule
Intervention descriptions: intervention 1: Placebo Inhalation powder inhaled once daily for 6 weeks' treatment intervention 2: Dose B inhaled once daily for 6 weeks' treatment intervention 3: Dose A inhaled once daily for 6 weeks' treatment intervention 4: One placebo capsule taken each day on the last 7 days of the study intervention 5: Prednisolone 10mg oral capsule taken each day on the last 7 days of the study

Protocol document: