ZAFIRLUKAST FOR SYMPTOMATIC MILD-TO-MODERATE ASTHMA - A 13-WEEK MULTICENTER STUDY

The efficacy of the oral leukotriene-receptor antagonist zafirlukast w as assessed as maintenance therapy for patients with mild-to-moderate asthma. A total of 762 patients aged 12 to 76 years were enrolled in a 13-week, multicenter, double-masked, placebo-controlled, parallel-gro up trial and randomly assigned to receive either zafirlukast (20 mg tw ice daily) or placebo. Patients were maintained on as-needed beta-agon ist therapy throughout the study and had to have a cumulative daytime asthma symptoms score greater than or equal to 8 (on a daily scale of 0 to 3) over 7 consecutive days before randomization. Efficacy was ass essed by changes in symptoms, beta-agonist use, and pulmonary function . Safety was assessed by adverse experiences, laboratory test results, physical examination, and electrocardiography. Zafirlukast significan tly decreased daytime asthma symptoms scores (-26.5%), nighttime awake nings (-19.8%), mornings with asthma (-29.0%), and beta-agonist use (- 22.3%) and significantly increased morning peak expiratory flow rate ( 6.9%) and forced expiratory volume in I second (6.3%) compared with pl acebo. Changes in symptoms, beta-agonist use, and pulmonary function o ccurred within 2 days of zafirlukast treatment and continued throughou t the trial. Zafirlukast was well tolerated. Pharyngitis and headache were the most common adverse events, occurring with similar frequency in both the zafirlukast and placebo groups. No clinically significant changes were observed in laboratory test results, findings on physical examination, or electrocardiographic findings. We conclude that zafir lukast produces early and sustained effects in the treatment of mild-t o-moderate asthma.