Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 781
Healthy volunteers: no

Brief summary:
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate (F)\[MF/F\] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by The Area Under the Curve From 0 to 12 Hours \[AUC\](0-12 hours) of the Change From Baseline to the Week 12 Endpoint

in Forced Expiratory Volume in One Second (FEV1) \[Time Frame: Baseline to Week 12\] and Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.

Detailed description:

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

Interventions: intervention 1: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID intervention 2: Mometasone furoate MDI (MF MDI) 200 mcg intervention 3: formoterol fumarate 10 mcg intervention 4: Placebo
Intervention descriptions: intervention 1: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks intervention 2: MF 200 mcg via metered dose inhaler twice daily for 26 weeks intervention 3: F via metered dose inhaler 10 mcg twice a day for 26 weeks intervention 4: Placebo metered dose inhaler twice a day for 26 weeks

Protocol document: