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, leading to significant morbidity and mortality. A simplified, once-daily dosing regimen may foster improved compliance. Objective: To compare the efficacy and safety of once-daily (AM) administration 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 group 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 effective than placebo (P less than or equal to .05) in improving FEV1. Based on morning peak expiratory flow rate, once-daily MF DPI 400 mu g was more effective than placebo (P less than or equal to .001) at endpoint. Both active treatments also demonstrated improvement at endpoint in asthma symptom scores, physician-evaluated response to therapy and use of rescue medication. Although both MF DPI dosages were efficacious, MF DPI 400 mu g provided additional improvement in some measures of pulmonary function (eg, morning PEFR) when these agents were administered once daily in the morning, Both doses of 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 mild or moderate persistent asthma.