12-week, multicenter, randomized, double-blind, double-dummy parallel-group trial compared efficacy and safety of fluticasone propionate (FP), beclomethasone dipropionate (BDP) and placebo (PLA) in 299 steroid naive asthma patients aged 12 and up previously treated with beta-agonist therapy. FP was administered via Diskus, a new 60-dose dry powder device, at blister doses of 100mcg BID (FP-BID) and 200mcg QD (FP-QD). BDP was given at 168mcg BID (exactuator dose) via metereddose inhaler. Visits were scheduled every 1-2 weeks. Subjects were dropped for lack of efficacy (LOE) when meeting predefined criteria for changes in FEV~, PEF, or nighttime awakenings. Fewer patients on FP-BID (n = 5) and FP-QD (n = 7) were dropped for LOE vs PLA (n = 19; p<0.01). There were no significant differences between BDP vs PLA treated patients in LOE withdrawal rates. Mean FEV l at baseline was 2.56-2.62L (67.7-68.8% predicted). After 1 week of treatment, FEV~ improved by 13-14% on all active treatments (p<0.05 vs PLA). FP-BID, FP-QD and BDP treatment significantly improved FEV 1 at endpoint (last treatment visit) (p<0.05 vs PLA). All active treatments significantly improved change in PEF from baseline to endpoint (p<0.005 vs PLA) with concurrent decreased use of beta-agonist (p<0.05 vs PLA). Adverse event rates were low and comparable across treatment groups. Overall, low dose FP-BID and FP-QD improved lung function with efficacy.
