Dose-ranging study of a new steroid for asthma: mometasone furoate dry powder inhaler

A new formulation of mometasone furoate (MF) for administration by dry powd er inhaler (DPI) was evaluated for the treatment of asthma. A 12-week, doub le-blind, placebo-controlled dose-ranging study compared the efficacy and s afety of three doses of MF DPI (100, 200 and 400 meg b.i.d) with beclometha sone dipropionate (BDP) 168 meg b.i.d. administered by metered dose inhaler in 365 adult or adolescent patients being treated with inhaled glucocortic oids. The mean change from baseline to endpoint (last treatment visit) for forced expiratory volume in 1 sec (FEV1) was the primary efficacy variable. Secondary efficacy variables included other objective measures of pulmonar y function [forced vital capacity (FVC), forced expiratory flow 25-75% (FEV 25-75%.) and peak expiratory flow rate (PEFR)] as well as subjective measur es of therapeutic response (patients' daily evaluation of asthma symptoms a nd physicians' evaluation). At endpoint, all four active treatments were si gnificantly more effective than placebo (P < 0.01) in improving FEV1 (MF DP I 5 to 7%, BDP 3%, placebo -6.6%) and all other measures of pulmonary funct ion (FVC: MF DPI 4 to 5%, BDP 2%, placebo -4.7%; FEF25-75%: MF DPI 6 to 18% , BDP 7.5%, placebo -9.5%; PEFR (AM): MF DPI 5 to 10%, BDP 5.7%, placebo -7 %). A consistent trend was observed for better improvement in patients trea ted with MF DPI 200 meg b.i.d. than with MF DPI 100 meg b.i.d., with no app arent additional benefit of MF DPI 400 meg b.i.d. Results for the MF DPI 10 0 meg b.i.d. and BDP 168 meg b.i.d. treatment groups were similar. Patients ' and physicians' subjective evaluations of symptoms found similar improvem ent in the MF DPI 200 and 400 mcg b.i.d. treatment groups, which were sligh tly better than that in the MF DPI 100 meg b.i.d, group. Symptoms tended to worsen in the placebo group. MF DPI was well tolerated at all dose levels and the most frequently reported treatment-related adverse effects were hea dache, pharyngitis and oral candidiasis. No evidence of HPA-axis suppressio n was detected in any treatment group. In summary, all doses of MF DPI were well tolerated and significantly improved lung function and MF DPI 400 meg (200 meg b.i.d.) was the optimal dose in this study of patients with moder ate persistent asthma. (C) 1999 HARCOURT PUBLISHERS LTD.