EVALUATION OF FLUTICASONE PROPIONATE (500 MU-G DAY(-1)) ADMINISTERED EITHER AS DRY POWDER VIA A DISKHALER(R) INHALER OR PRESSURIZED INHALER AND COMPARED WITH BECLOMETHASONE DIPROPIONATE (1000 MU-G DAY(-1)) ADMINISTERED BY PRESSURIZED INHALER

Five hundred and eighty-five patients with moderate asthma, currently recevving 400–1000 μg day−1 of an inhaled corticosteroid, were treated for 6 weeks in a double-blind, randomized, parallel group study with either 500 μg day−1 fluticasone propionate as a dry powder via a Diskhaler® inhaler, 500 μg day−1 fluticasone propionate via a pressurized inhaler or 1000 μg day−1 beclomethasone dipropionate via a pressurized inhaler. For all three treatment groups, mean morning and evening peak expiratory flow rates (PEFRs) increased within 1 week of the start of treatment. There were also improvements in clinic lung function, daytime and nigh-time asthma symptoms and a reduction in daytime and night-time rescue bronchodilator medication in all three groups. There were no statistically significant differences between the two formulations of fluticasone propionate in any of the efficacy parameters. Fluticasone propionate via the Diskhaler was significantly more effective than beclomethasone dipropionate over the 6 week study period in reducing diurnal variation (mean difference—41 min−1, 95% CI-8 to 01 min−1:P=0·03). Fluticasone propionate via the Diskhaler produced a statistically significant improvement in night-time symptoms when compared to beclomethasone dipropionate whereas, beclomethasone dipropionate 1000 μg day−1 was statistically significantly more effective than both formulations of fluticasone propionate in improving daytime symptoms (P<0·05). However, these statistical differences must be viewed together with the fact that very few patients recorded a score of 2 or more for both daytime or nighttime symptoms. There was a similarly low incidence of adverse events with all three treatments with no evidence of hypothalamic pituitary adrenal (HPA)-axis suppression. The results of the 6-week comparative study showed that 500 μg day−1 fluticasone propionate whether administered via pressurized inhaler or Diskhaler is as effective and as safe as 1000 μg day−1 beclomethasone dipropionate administered via a pressurized inhaler in the treatment of moderate asthma. Over 12 months fluticasone propionate 500 μg day−1 via a pressurized inhaler was at least as effective and as well tolerated as beclomethasone dipropionate 1000 μg day−1. © 1993, Baillière Tindall. All rights reserved.