Conditions: Asthma
Keywords: Glucocorticosteroids Dry Powder Inhaler Bronchodilator Metered-Dose Inhaler
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 722
Healthy volunteers: yes

Brief summary:
This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.

Detailed description:

Arms:
arm 1: Mometasone furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily. arm 2: Fluticasone propionate/salmeterol (F/SC) 250/50 mcg BID

Interventions: intervention 1: Mometasone furoate/formoterol (MF/F) MDI intervention 2: Fluticasone propionate/salmeterol (F/SC) DPI
Intervention descriptions: intervention 1: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks. intervention 2: Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks.

Protocol document: