A comparison of multiple doses of fluticasone propionate and beclomethasone dipropionate in subjects with persistent asthma

Abstract

Background: Inhaled corticosteroids are recommended for the treatment of persistent asthma. Comparative clinical studies evaluating 2 or more doses of these agents are few. Objective: We sought to compare the efficacy and safety of 2 doses of fluticasone propionate (88 μg twice daily and 220 μg twice daily) with 2 doses of beclomethasone dipropionate (168 μg twice daily and 336 μg twice daily) in subjects with persistent asthma. Methods: Three hundred ninety-nine subjects participated in this randomized, double-blind, parallel-group clinical trial. Eligible subjects were using daily inhaled corticosteroids and had an FEV 1 of 45% to 80% of predicted value. Clinic visits, including spirometry, were conducted every 1 to 2 weeks. Subjects recorded symptoms, use of albuterol, and peak expiratory flows on daily diary cards. Results: Fluticasone propionate treatment resulted in significantly ( P ≤ .034) greater improvements in objective pulmonary function parameters than did beclomethasone dipropionate treatment and significantly greater reductions in daily albuterol use ( P ≤ .010) and asthma symptoms ( P ≤ .027). Both low-dose (88 μg twice daily) and medium-dose (220 μg twice daily) fluticasone propionate significantly increased FEV 1 compared with higher doses of beclomethasone dipropionate ( P = .006). Low-dose and medium-dose fluticasone propionate improved FEV 1 by 0.31 L (14%) and 0.36 L (15%), respectively, compared with improvements of 0.18 L (8%) and 0.21 L (9%) with low-dose and medium-dose beclomethasone dipropionate. The adverse event profiles were similar for both medications. Conclusion: Fluticasone propionate provides greater asthma control at roughly half the dose of beclomethasone dipropionate, with a comparable adverse event profile. (J Allergy Clin Immunol 1999;103:796-803.)