Nocturnal asthma - Effect of salmeterol on quality of life and clinical outcomes

Objective: To evaluate the effect of salmeterol on asthma-specific quality of life in patients experiencing significant nocturnal symptoms. Design: Randomized, double-blind, placebo-controlled, multicenter clinical trial, Setting: Allergy/respiratory care clinics. Patients: Nonsmokers greater than or equal to 12 years of age with nocturna l asthma symptoms on at least 6 of 14 days during screening and greater tha n or equal to 15% decrease in peak expiratory flow (PEF) from baseline on n octurnal awakening at least once during screening, Interventions: Salmeterol, 42 mu g, or placebo twice daily. Patients were a llowed to continue theophylline, inhaled corticosteroids, and "as-needed" a lbuterol, Measurements and results: Outcome measures included Asthma Quality of Life Questionnaire (AQLQ) global and individual domain scores, FEV1, PEF, nightt ime awakenings, asthma symptoms, and supplemental albuterol use, Mean chang e from baseline for the global and domain AQLQ scores was significantly gre ater (p less than or equal to 0.005) with salmeterol compared with placebo. At week 12, salmeterol significantly (p < 0.001 compared with placebo) inc reased mean change from baseline in FEV1, morning and evening PEF, percenta ge of symptom-free days, percentage of nights with no awakenings due to ast hma, and the percentage of days and nights with no supplemental albuterol u se, Significant improvements in PEF vr ere observed after treatment with sa lmeterol regardless of concomitant treatment with theophylline (p < 0.05), Conclusions: These results provide evidence that validates the role of salm eterol in improving quality of life in patients with moderate persistent as thma who exhibited nocturnal asthma symptoms and supports the efficacy of s almeterol compared with that of placebo (ie, "as-needed" albuterol).