Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 834
Healthy volunteers: no

Brief summary:
This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive open-label MF MDI 400 mcg 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 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).

Detailed description:

Arms:
arm 1: Mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily

Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period arm 2: Mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily

Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period arm 3: Mometasone Furoate 400 mcg taken twice daily

Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period

Interventions: intervention 1: Mometasone furoate/formoterol (MF/F) combination intervention 2: Mometasone furoate/formoterol (MF/F) combination intervention 3: Mometasone furoate MDI (MF MDI)
Intervention descriptions: intervention 1: MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks intervention 2: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks intervention 3: MF 400 mcg via metered dose inhaler twice daily for 12 weeks

Protocol document: