FLUTICASONE PROPIONATE POWDER ADMINISTERED THROUGH DISKHALER VERSUS TRIAMCINOLONE ACETONIDE AEROSOL ADMINISTERED THROUGH METERED-DOSE INHALER IN PATIENTS WITH PERSISTENT ASTHMA

Background: Attempts to delineate efficacy and safety differences amon g inhaled corticosteroids have been difficult because of the lack of w ell-controlled, comparative studies re ported in the medical literatur e. Methods: A randomized, double-blind, double-dummy study was conduct ed in 24 outpatient centers. A total of 291 male and female patients a t least 12 years of age with asthma (FEV, between 50% and 80% of predi cted value), who had previously received maintenance therapy with becl omethasone dipropionate or triamcinolone acetonide, were switched to t reatment with fluticasone propionate powder (250 mu g twice daily), tr iamcinolone acetonide aerosol (200 mu g four times daily), or placebo for 24 weeks. Results: Mean increase in FEV, from baseline to end poin t was significantly (p = 0.009) greater in patients switched to treatm ent with fluticasone compared with patients switched to treatment with triamcinolone (0.27 L and 0.07 L, respectively). At end point, mean i ncrease in morning peak expiratory flow from baseline was 21 L/min wit h fluticasone compared with mean decreases of 6 L/min and 28 L/min wit h triamcinolone and placebo, respectively (p < 0.001 vs triamcinolone and placebo). Supplemental rescue albuterol use decreased by 30% from baseline with fluticasone (p < 0.05 vs triamcinolone and placebo) comp ared,vith triamcinolone (6%) or placebo (increased by 50%). The percen tage of patients withdrawn from the study because they met predefined lack-of-efficacy criteria was higher with placebo (60%) and triamcinol one (27%) than with fluticasone (17%), Incidence of adverse events and low morning plasma cortisol concentrations were similar across treatm ent groups except for oral candidiasis (p = 0.035, fluticasone vs plac ebo). Conclusion: Fluticasone propionate powder twice daily (500 mu g/ day) was superior in efficacy to triamcinolone acetonide aerosol four times daily (800 mu g/day) in patients with persistent asthma.