Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 566
Healthy volunteers: no

Brief summary:
This is a randomized, multi-center, parallel-group, active-controlled, double-blind study evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral density (BMD) in subjects with asthma. The mean percent change in lumbar spine BMD from the averaged baseline value (the average of the two scan results prior to treatment) to the endpoint of treatment time point (the average of the last two valid post-baseline scan results during treatment) for the comparison of MF DPI 400 mcg daily in the evening versus montelukast (ML) 10 mg daily in the evening.

Detailed description:

Arms:
arm 1: MF DPI 400 mcg once a day (QD) in the evening (PM) arm 2: MF DPI 200 mcg QD PM arm 3: Fluticasone propionate (FP) metered dose inhaler (MDI) 250 mcg twice a day (BID) arm 4: ML 10 mg QD PM

Interventions: intervention 1: mometasone furoate dry powder inhaler intervention 2: mometasone furoate dry powder inhaler intervention 3: fluticasone propionate hydrofluoroalkane (HFA) intervention 4: montelukast
Intervention descriptions: intervention 1: 400 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year. intervention 2: 200 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year. intervention 3: 250 mcg FP HFA given twice a day via a metered-dose inhaler and a placebo tablet given once daily in the evening for 1 year intervention 4: 10 mg given once daily in the evening by mouth for 1 year.

Protocol document: