Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 404
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids (ICS); evaluator-blind.

In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI 500/50 mcg BID will be evaluated.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: mometasone furoate combination MDI 200/10 mcg BID intervention 2: mometasone furoate combination MDI 400/10 mcg BID intervention 3: Fluticasone/Salmeterol 250/50 mcg BID intervention 4: Fluticasone/Salmeterol 500/50 mcg BID
Intervention descriptions: intervention 1: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year intervention 2: MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year intervention 3: F/SC 250/50 twice daily for 1 year intervention 4: F/SC 500/50 twice daily for 1 year

Protocol document: