INHALED FORMOTEROL DRY POWDER IN THE TREATMENT OF PATIENTS WITH REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE - A 3-MONTH, PLACEBO-CONTROLLED COMPARISON OF THE EFFICACY AND SAFETY OF FORMOTEROL AND SALBUTAMOL, FOLLOWED BY A 12-MONTH TRIAL WITH FORMOTEROL

Inhaled formoterol is a potent selective beta(2)-agonist with rapid on set and at least 12-h duration of bronchodilation. The aim of the stud y was to compare the bronchodilating effect of inhaled formoterol dry powder (dp) 12 mu g b.i.d. with salbutamol dp 400 mu g q.i.d. and plac ebo in patients with reversible obstructive airway disease (ROAD). The study design consisted of a closed 12-week double-blind, placebo-cont rolled, multicenter trial followed by an open noncomparative, multicen ter, 12-month follow-up trial, in which the tolerability of formoterol dp was assessed. A total of 304 patients (146 men, 158 women) aged 18 -79 years, ill during 0.1-64 years, were randomized. No demographic or baseline differences were found among the different treatment groups. The bronchodilating effect of formoterol, assessed by morning premedi cation PEFR, was significantly superior to placebo (P<0.0001) and salb utamol (P<0.0001). Efficacy was maintained during the open follow-up s tudy with 12 mu g b.i.d. in most of the patients. A few patients, howe ver, needed 24 mu g b.i.d. to control their ROAD. Formoterol 12 mu g b .i.d. significantly reduced morning and evening asthma symptoms and sl eep disturbances, and reduced significantly the need for rescue medica tion. The tolerability of the three treatment groups was comparable. I n conclusion, formoterol 12 mu g dp b.i.d. was significantly superior to both salbutamol 400 mu g dp q.i.d. and placebo, and reduced asthma symptoms significantly. Overall, formoterol showed a tolerability prof ile comparable to that of salbutamol, and no tachyphylaxis was observe d during 1 year of treatment.