Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 180
Healthy volunteers: no

Brief summary:
This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated with inhaled corticosteroids (ICS) or without ICS with diagnosed mild persistent or moderate persistent asthma (classified as Global Initiative For Asthma, 2005) in the previous 4 weeks. The primary efficacy endpoint is percent change from baseline in FEV1.

Detailed description:

Arms:
arm 1: MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) arm 2: Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day)

Interventions: intervention 1: mometasone furoate dry powder inhaler intervention 2: Budesonide DPI
Intervention descriptions: intervention 1: MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks. intervention 2: Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks.

Protocol document: