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* From the Division of Allergy and Immunology (Dr. Lockey), University of South Florida College of Medicine, Tampa, FL; Allergy and Arthritis Family Treatment Center (Dr. DuBuske), Gardner, MA; Allergy, Asthma, Bronchitis and Immunology Associates (Dr. Friedman), Fountain Valley, CA; and Glaxo Wellcome Inc (Ms. Petrocella, and Drs. Cox and Rickard), Research Triangle Park, NC.
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 
12 years of age with nocturnal
asthma symptoms on at least 6 of 14 days during screening and 15%
decrease in peak expiratory flow (PEF) from baseline on nocturnal
awakening at least once during screening.
Interventions: Salmeterol, 42 µg, or placebo twice daily. Patients were allowed to continue theophylline, inhaled corticosteroids, and "as-needed" albuterol.
Measurements
and results: Outcome measures included Asthma Quality of Life
Questionnaire (AQLQ) global and individual domain scores,
FEV1, PEF, nighttime awakenings, asthma symptoms, and
supplemental albuterol use. Mean change from baseline for the global
and domain AQLQ scores was significantly greater (p 
0.005) with
salmeterol compared with placebo. At week 12, salmeterol significantly
(p < 0.001 compared with placebo) increased mean change from
baseline in FEV1, morning and evening PEF, percentage of
symptom-free days, percentage of nights with no awakenings due to
asthma, and the percentage of days and nights with no supplemental
albuterol use. Significant improvements in PEF were observed after
treatment with salmeterol regardless of concomitant treatment with
theophylline (p < 0.05).
Conclusions: These results provide evidence that validates the role of salmeterol in improving quality of life in patients with moderate persistent asthma who exhibited nocturnal asthma symptoms and supports the efficacy of salmeterol compared with that of placebo (ie, "as-needed" albuterol).
Key Words: asthma • nocturnal • pharmacoeconomics • quality of life • randomized controlled trial • salmeterol
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