Mometasone furoate administered once daily is as effective as twice-daily administration for treatment of mild-to-moderate persistent asthma

Abstract

Background: Despite current recommendations, many patients with persistent asthma are still treated with bronchodilators alone. Objective: The safety and efficacy of two once daily dosing regimens (200 μg and 400 μg) of mometasone furoate (MF) administered in the morning by using a dry-powder inhaler (DPI) were compared with those of a twice daily dosing regimen (200 μg administered twice daily) in patients with mild-to-moderate persistent asthma previously taking only inhaled β2-adrenergic agonists. Methods: All patients (306 patients; age range, 12-70 years) were given a diagnosis of asthma for at least 6 months before enrollment in this 12-week, placebo-controlled, double-blind, randomized study. The primary efficacy variable was change in FEV1 from baseline to endpoint (last evaluable visit). Results: At endpoint, FEV1 was significantly improved (P ≤ .02) after MF-DPI 400 μg once daily morning treatment and MF-DPI 200 μg twice daily treatment (16.0% and 16.1%, respectively) compared with placebo (5.5%). The improvement seen with MF-DPI 200 μg once daily morning treatment (10.4%) was not significantly different from that with placebo. Secondary efficacy variables also showed significant improvement for the MF-DPI 400 μg once daily morning treatment group and the MF-DPI 200 μg twice daily treatment group compared with the placebo group. All doses of MF administered by means of a DPI were well tolerated. Conclusion: This is the first study to demonstrate that a total daily dose of 400 μg of MF administered by means of a DPI is an effective treatment for patients with mild-to-moderate persistent asthma previously taking only inhaled β2-adrenergic agonists. This treatment was equally effective when administered either as a once daily or twice daily regimen.