LOW-DOSE FORMOTEROL TURBUHALER(R) (OXIS(R)) BID, A 3-MONTH PLACEBO-CONTROLLED COMPARISON WITH TERBUTALINE (QID)

This study compared the efficacy of a low dose of formoterol Turbuhale r(R) 6 mu g b.i.d. (F) with that of terbutaline 0.5 mg q.i.d. (T), and placebo (P) from Turbuhaler(R). After a 2-week run-in, 397 adults wit h mild to moderate asthma were randomly allocated to one of the treatm ents for 12 weeks. During run-in, the mean morning peak expiratory how (PEF) was 360 (F), 368 (T) and 3671min(-1) (P). F was better than T ( P=0.014) and P (P=0.0001) in improving morning PEF [mean changes from run-in: 20 (F), 9 (T), and 21 min(-1) (P)]. F was statistically signif icantly more effective than either T or P in reducing asthma symptoms. F gave also statistically significantly higher evening PEF and less u se of rescue medication than P. Bronchodilator response to study drugs and additional 1.25 mg terbutaline was similar before and after the 1 2-week treatment period. There were no adverse effects of clinical rel evance. In conclusion, formoterol Turbuhaler, 6 mu g b.i.d. was more e ffective in improving PEF and offered better asthma control than eithe r terbutaline Turbuhaler, 0.5 mg q.i.d. or placebo. Regular use of for moterol did not reduce the bronchodilator response to additional terbu taline. There were no clinically relevant adverse effects.