Combined salmeterol 50 μg and fluticasone propionate 250 μg in the Diskus device for the treatment of asthma.

Three hundred forty-nine patients with asthma previously treated with medium doses of inhaled corticosteroids during a 2-wk, single-blind, run-in period were randomized to treatment with salmeterol 50 mu g combined with fluticasone propionate (FP) 250 mu g, salmeterol 50 mu g, FP 250 mu g, or placebo, each given twice daily through a Diskus device for 12 wk. Mean change in FEV1 at endpoint was significantly (p less than or equal to 0.001) greater with the salmeterol/FP combination product (0.48 L) than with placebo (-0.11 L), salmeterol (0.05 L), or FP (0.25 L). The combination product significantly increased the area under the 12-h serial FEV1 curve relative to baseline over that with placebo, salmeterol, or FP at Day 1, Week 1, and Week 12 (p less than or equal to 0.025). Patients in the combination-product group had a significantly greater probability of remaining in the study without being withdrawn because of worsening asthma than did patients in the placebo, salmeterol, or FP groups (p less than or equal to 0.002). The combination product significantly increased (p < 0.001) morning PEF at endpoint (53.5 L/min) as compared with placebo (-14 L/min), salmeterol (-11.6 L/min), or FP (15.2 L/min). The combination product significantly (p less than or equal to 0.011) reduced asthma symptom scores and supplemental albuterol use, and significantly increased the percentage of nights with no awakenings as compared with placebo, salmeterol, and FP (p less than or equal to 0.016). Combination treatment with salmeterol 50 mu g and FP 250 mu g given twice daily from the Diskus device provided better asthma control and greater improvement in pulmonary function than did the individual agents, and may simplify the management of asthma in patients who need both classes of drugs for optimal control of their disease.