Salmeterol/fluticasone propionate (50/500 mu g) in combination in a Diskus(R) inhaler (Seretide (R)) is effective and safe in the treatment of steroid-dependent asthma

This multicentre double-blind, double-dummy study compared the safety and e fficacy of a new combination Diskus (R) inhaler containing both salmeterol 50 mu g and fluticasone propionate 500 mu g (Seretide (R), GlaxoWellcome, F rance) with the same doses of the two drugs delivered via separate Diskus ( R) inhalers and with the same dose of fluticasone propionate alone. Patient s were eligible for study entry if they had received an inhaled corticoster oid continuously for 12 weeks prior to run-in, and had received treatment w ith beclomethasone dipropionate or budesonide 1500-2000 mu g day(-1) or flu ticasone propionate 750-1000 mu g day(-1) for at least 4 weeks prior to run -in. In total, 503 patients receiving inhaled corticosteroids were randomiz ed to 28 weeks' treatment with either salmeterol/fluticasone propionate (50 /500 mu g) via a single Diskus (R) inhaler (combination) and placebo, or sa lmeterol 50 mu g and fluticasone propionate 500 mu g administered via separ ate Diskus (R) inhalers (concurrent), or fluticasone propionate 500 mu g an d placebo. All treatments were administered twice daily, mean morning peak expiratory flow rate (PEFR) and asthma symptoms were measured for the first 12 weeks and safety data were collected throughout the 28-week study. Over weeks 1 to 12, improvement in adjusted mean morning PEFR was 35 and 33 1 m in(-1), respectively, in the combination and concurrent therapy treatment g roups (12 and 10% increase from baseline, respectively). The mean differenc e between treatments was -3 1 min(-1) (90% confidence interval - 10.4 1 min (-1)) which was within the criteria for clinical equivalence. However, the combination therapy was statistically significantly superior to fluticasone propionate alone for mean morning PEFR (P < 0.001) and other measures of l ung function, whilst clinical equivalence of the combination and concurrent therapies was observed. All three treatments were well tolerated. In addit ion, there were no differences between the three treatments in either the c hange in serum cortisol or urinary cortisol concentrations, which, for each treatment group, were no significantly different from baseline at the end of the treatment period. Thus, the combination of salmeterol and fluticason e propionate in a single inhaler is as well tolerated and effective in achi eving asthma control in steroid-dependent patients as the separate administ ration of the two drugs, and both combination and concurrent therapy are su perior to administration of the same dose of corticosteroid alone. (C) 1999 HARCOURT PUBLISHERS LTD.