SALMETEROL POWDER COMPARED WITH ALBUTEROL AEROSOL AS MAINTENANCE THERAPY FOR ASTHMA IN ADOLESCENT AND ADULT PATIENTS

Two multicenter, randomized, double-masked, placebo-controlled studies involving 451 adolescent and adult patients with mild-to-moderate ast hma compared the efficacy and safety of salmeterol powder 50 mu g mice daily with albuterol 180 mu g four times daily or placebo (with albut erol as needed) for 12 weeks. Patients had forced expiratory volume in 1 second (FEV1) of 50% to 80%. Throughout the 12-week treatment perio d, the mean change from baseline in percentage of predicted FEV1 was s ignificantly greater with salmeterol than with placebo; mean area unde r the curve for FEV1 was significantly greater with salmeterol than wi th albuterol or placebo. Significant improvements in morning and eveni ng peak expiratory flow, percentage of nights without awakening, and a sthma symptoms were observed with salmeterol. Salmeterol was well tole rated, and no clinically significant changes in electrocardiographic a ctivity were observed.