SALMETEROL COMPARED WITH CURRENT THERAPIES IN CHRONIC ASTHMA

BACKGROUND. Therapy with salmeterol, a long-acting, selective, inhaled beta(2)-adrenergic agonist, is effective and safe for patients with p ersistent asthma; however, few long-term studies comparing salmeterol with current combination treatment regimens have been reported. METHOD S. A multicenter, randomized, placebo-controlled, double-blind study w as conducted in 386 patients over 41 to 46 weeks in 27 medical centers (two thirds of the investigators were primary care physicians). Patie nts were randomized to receive either salmeterol or placebo, and furth er randomized to weaning or nonweaning from current asthma therapies ( except inhaled corticosteroids). Treatment groups were: salmeterol/wea ning (S + W), placebo/weaning (P + W), salmeterol/no weaning (S + NW), and placebo/no weaning (P + NW). Attempts at active weaning were carr ied out at the discretion of the investigator for 2 to 6 weeks, Pulmon ary function, albuterol use, and asthma symptoms were measured. RESULT S. The clinical benefits of salmeterol occurred despite weaning off ex isting nonsteroidal asthma medications. The mean morning peak expirato ry flow rate was significantly increased in the S + W group (32.3 L/mi n) compared with both the P + W (4.9 L/min) and P + NW (6.8 L/min) gro ups (P < .001), Compared with the P + W and P + NW groups, the S + W g roup experienced significant (P < .05) improvements in overall mean as thma symptom scores, mean number of puffs of supplemental albuterol, t he percentage of days with no supplemental albuterol use, and the mean number of awakenings caused by asthma (except for the P + NW comparis on, P = .090). No significant differences were noted between treatment groups in any safety evaluation, including 12-lead electrocardiograms . CONCLUSIONS. The addition of salmeterol in the treatment of persiste nt asthma resulted in sustained improvement in pulmonary function and symptoms. The long-term use of salmeterol is safe and improves the cli nical course and stability of asthma following reductions in nonsteroi dal asthma therapy.