A 3-MONTH COMPARISON OF FORMOTEROL WITH TERBUTALINE VIA TURBUHALER - A PLACEBO-CONTROLLED STUDY

Background and aim: Oxis Turbuhaler is a new dry powder formulation of long-acting beta(2)-agonist formoterol. This study compared the effic acy and safety of regular use of the long-acting beta(2)-agonist formo terol and the short-acting terbutaline for 3 months in patients with a sthma. Method: After 1-week run-in, 343 patients received either formo terol 12 mu g bid (F) (delivered dose of 9 mu g), terbutaline 500 mu g qid (T) or placebo qid, in a parallel-group, double-blind, randomized manner. They had a mean of 61% of predicted forced expiratory volume in 1 second (FEV1) and a mean reversibility of 26%. Eighty-nine percen t used inhaled corticosteroids. Results: During run-in mean morning pe ak expiratory flow (PEF L/min) for F was 366 and 348 for T, and 344 fo r placebo (P). The F group improved morning PEF significantly compared with P (P = .0022) and T (P = .0001). Changes from run-in were +18, - 1.5, and +5 L/min after F, T, and P, respectively. The F group was sta tistically significantly better than P and T in increasing evening PEF and in reducing night-time asthma. The F and T statistically signific antly reduced the use of rescue medication compared with P. The bronch odilating response to the study drug and to an additional 1.25 mg terb utaline was of the same magnitude before and throughout the study. No statistically significant treatment-by-time interaction was observed ( P > .20). There were no adverse effects of clinical relevance. Conclus ion: Formoterol Turbuhaler, 12 mu g bid, was more effective than terbu taline Turbuhaler, 0.5 mg qid, and placebo. Regular use of formoterol or terbutaline did not significantly influence the response to additio nal inhalation of terbutaline.