Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma

Background: Although inhaled glucocorticoids are recommended for all stages of persistent asthma, compliance with long-term therapy is often poor, lea ding to significant morbidity and mortality. A simplified, once-daily dosin g regimen may foster improved compliance. Objective: To compare the efficacy and safety of once-daily (AM) administra tion of mometasone furoate dry powder inhaler (MF DPI) 200 mu g and 400 mu g with placebo in patients with asthma previously maintained only on short- acting inhaled beta-adrenergic receptor agonists. Methods: This was a 12-week, double-blind, placebo-controlled, parallel gro up study. The mean change from baseline to endpoint (last treatment visit) for FEV1 was the primary efficacy variable. Results: At endpoint, both doses of MF DPI were significantly more effectiv e than placebo (P less than or equal to .05) in improving FEV1. Based on mo rning peak expiratory flow rate, once-daily MF DPI 400 mu g was more effect ive than placebo (P less than or equal to .001) at endpoint. Both active tr eatments also demonstrated improvement at endpoint in asthma symptom scores , physician-evaluated response to therapy and use of rescue medication. Alt hough both MF DPI dosages were efficacious, MF DPI 400 mu g provided additi onal improvement in some measures of pulmonary function (eg, morning PEFR) when these agents were administered once daily in the morning, Both doses o f MF DPI were well tolerated and treatment-related adverse events occurred at a similar incidence among the three treatment groups. Conclusions: The results of this study indicate that once-daily (AM) MF DPI provides a convenient and effective treatment option for patients with mil d or moderate persistent asthma.