Efficacy, safety, and impact on quality of life of salmeterol in patients with moderate persistent asthma

Objective: To evaluate the efficacy, safety, and impact on asthma-specific quality of life of salmeterol, a highly selective, long-acting beta(2)-agon ist, compared with that of placebo (ie, "as-needed" albuterol). Study Design: Randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Patients and Methods: Five hundred thirty-eight nonsmoking symptomatic pati ents 12 years of age and older meeting American Thoracic Society asthma cri teria were enrolled at 55 outpatient clinics; 443 patients completed the st udy. Patients were randomly assigned to treatment with either salmeterol ae rosol 42 mu g twice daily or placebo (as-needed albuterol) for 12 weeks. We assessed changes in quality of life using the Asthma Quality of Life Que stionnaire (AQLQ). Efficacy measurements included daily peak expiratory flo w (PEF) rate, daytime and nighttime asthma symptoms, results of pulmonary f unction tests, and supplemental albuterol use. Patients recorded their PEF rate, supplemental albuterol use, and asthma-related symptoms daily. Pulmon ary function tests and AQLQ assessments were performed at baseline and afte r 4, 8, and 12 weeks of treatment. Safety measurements included vital signs , physical examination, and reports of clinical adverse events at baseline and after 4, 8, and 12 weeks of treatment. Results: Mean changes from baseline in AQLQ global and domain scores were s ignificantly greater in the salmeterol group compared with the placebo grou p (P < 0.001). Patients treated with salmeterol also had significant improv ements in mean PEF rates, supplemental albuterol use, asthma symptom scores , and forced expiratory volume in 1 second compared with those given placeb o. Both salmeterol and placebo were well tolerated and were not associated with any clinically significant changes in vital signs or physical examinat ion findings. Conclusions: Salmeterol 42 mu g twice daily resulted in significantly great er improvements in asthma-specific quality of life, pulmonary function, and asthma symptoms compared with placebo (as-needed albuterol) in patients wi th moderate persistent asthma.