Montelukast, a once-daily leukotriene receptor antagonist, in the treatment of chronic asthma -: A multicenter, randomized, double-blind trial
Montelukast, a once-daily leukotriene receptor antagonist, in the treatment of chronic asthma -: A multicenter, randomized, double-blind trial
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DOI：
10.1001/archinte.158.11.1213
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发表时间：
1998-06-08
影响因子：
--
通讯作者：
Edwards, TB
中科院分区：
文献类型：
--
作者：
Reiss, TF;Chervinsky, P;Edwards, TB
Objectives: To determine the clinical effect of oral montelukast sodium, a leukotriene receptor antagonist, in asthmatic patients aged 15 years or more.Design: Randomized, multicenter, double-blind, placebo-controlled, parallel-group study. A 2-week, single-blind, placebo run-in period was followed by a 12-week, double-blind treatment period (montelukast sodium, 10 mg, or matching placebo, once daily at bedtime) and a 3-week, double-blind, washout period.Setting/Patients: Fifty clinical centers randomly allocated 681 patients with chronic, stable asthma to receive placebo or montelukast after demonstrating a forced expiratory volume in 1 second 50% to 85% of the predicted value, at least a 15% improvement in forced expiratory volume in 1 second (absolute value) after inhaled beta-agonist administration, a minimal predefined level of daytime asthma symptoms, and inhaled beta-agonist use. Twenty-three percent of the patients used concomitant inhaled corticosteroids.Primary End Points: Forced expiratory volume in 1 second and daytime asthma symptoms.Results: Montelukast improved airway obstruction (forced expiratory volume in 1 second, morning and evening peak expiratory flow rate) and patient-reported end points (daytime asthma symptoms, "as-needed" beta-agonist use, nocturnal awakenings) (P
