EVALUATION OF DIFFERENT DOSES OF FORMOTEROL FROM A NEWLY DEVELOPED POWDER INHALATION DEVICE IN ASTHMATIC-PATIENTS

Administration of different doses of formoterol from a recently develo ped multiple dose dry powder device was tested in a placebo-controlled , single-centre, double-blind, within-patient trial. Eighteen patients of both sexes, aged 18-65 years, with a FEV(1) of 50-80% and a revers ibility of at least 15% were randomized. During four treatment periods of 8 days each, divided by aproximately 6 days, patients received pla cebo or 6, 12 or 24 mu g (PL, F6, F12 and F24, respectively) of formot erol from the powder device. Efficacy parameters (FEV(1)) and safety p arameters (primarily pulse rate, electrocardiogram [ECG] and subjectiv e experiences) were evaluated during 24 hours on the last day of each treatment period. Peak now and the number of puffs of used rescue medi cation (100 mu g of salbutamol) were registered during treatment perio ds. For efficacy analysis, 17 patients remained. For FEV(1) 0.5 hour b efore the last dose and 12 and 24 hours after the last dose all formot erol doses were statistically significant superior to placebo. Clinica lly relevant differences from placebo were found up to 8 hours (F6) an d 12 hours (F12 and F24). The difference between doses was clinically relevant for the area under the FEV(1) curve between F6 and F24. PEF o n the treatment days corresponded to these findings. In three cases of 13 reported adverse effects, the relation to trial medication was pro bable (tremor) or possible (insomnia and hyperaesthesia). All other sa fety measurements showed no significant differences. We conclude that formoterol dry powder in the newly developed multiple dose inhalation device is an effective and safe beta(2)-stimulant with a long duration of action in doses of 6, 12 and 24 mu g. The 24 mu g dose is superior to the 6 mu g dose. Efficacy decreased considerably between the 12th and 24th hour after dosing.