Mometasone furoate: efficacy and safety in moderate asthma compared with beclomethasone dipropionate

Background: Mometasone furoate (MF) is a new inhaled glucocorticoid adminis tered by dry powder inhaler (DPI). Objective: MF-DPI was evaluated for safety and efficacy and compared with p lacebo DPI and beclomethasone dipropionate (BDP) administered by metered do se inhaler (MDI) in the treatment of patients with moderate persistent asth ma. Methods: Eligible patients (n = 227), 13 to 75 years of age, maintained on inhaled glucocorticoids before entering the trial, were randomized to recei ve: MF-DPI, 100 mug, twice daily, MF-DPI, 200 mug, twice daily, BDP MDI, 16 8 mug, twice daily, or placebo in a 12-week, multicenter, double-blind stud y. Results: At endpoint, FEV1 (primary efficacy variable) significantly improv ed for all three active treatments compared with placebo (P < .01, all comp arisons). The response to MF-DPI, 200 <mu>g, twice daily treatment was appr oximately twice as large as the response to MF-DPI, 100 mug twice daily or BDP MDI treatment, although the differences between these groups did not re ach statistical significance. Secondary efficacy variables including PEFR, asthma symptoms, nocturnal awakenings, and albuterol use showed similar tre nds. The MF-DPI, 100 mug, twice daily and BDP MDI, 168 mug, twice daily tre atment groups produced comparable results for all efficacy variables. Conclusions: MF-DPI, 100 mug and 200 mug, twice daily were well-tolerated a nd significantly improved lung function and symptom control in the treatmen t of patients with moderate persistent asthma. In this study, MF-DPI, 200 m ug, twice daily seemed to be the most effective dosage.