USE OF FORMOTEROL DRY POWDER ADMINISTERED FOR 3 MONTHS VIA A SINGLE-DOSE INHALER IN 1,380 ASTHMATIC-PATIENTS

Formoterol is a long-acting beta(2)-adrenoceptor agonist available in a single-dose breath-actuated device (Foradil(R)) for asthma treatment . Since efficacy and ease of use are key factors for compliance to the rapy, the aim of this study was to assess correct use, efficacy and sa fety of Foradil(R) in a 3-month, open, uncontrolled, multicenter trial . This study was performed on 1,380 patients with moderate or severe p ersistent asthma treated with inhaled corticosteroid (age: 48.4 +/- 16 .2 years; FEV1: 65.4 +/- 19.4% of normal). During the study, complianc e was over 90%. More than 90% of the patients used the inhaler correct ly and found it easy or very easy to use. The mean increase in peak ex piratory flow rate (PEFR), 30 to 60 min after inhalation, was 52.3 and 36.7 l/min for the morning and the evening respectively (p = 0.0001). This increase was already significant 5 min after inhalation, confirm ing the fast onset of action of formoterol. Mean predose PEFR and dayt ime/nocturnal symptom scores improved during the length of the study. Rescue short-acting beta(2)-agonist consumption was more than three ti mes reduced. At study completion, formoterol dosage was 12 mu g and 24 mu g twice daily for 71.5% and 28.5% of the patients respectively Phy sicians judged the overall efficacy as good or very good in 87.1% of t he patients, and they estimated the tolerability as very good or good in 92.6%. Drug-related adverse events were similar to those of other b eta(2)-agonists. In conclusion, this study demonstrated the ease of us e of this formoterol single-doss dry powder inhaler, and confirmed the good efficacy and safety profile of this long-acting bronchodilator i n asthma.