Oral Montelukast, Inhaled Beclomethasone, and Placebo for Chronic Asthma

作者：Kerstin Malmström, Guillermo Rodriguez-Gomez, Jeremias Guerra, Cesar Villaran, Andres Piñeiro, Lynn X. Wei, Beth C. Seidenberg, Theodore F. Reiss, for the Montelukast/Beclomethasone Study Group* · 发表于：Annals of Internal Medicine · 年份：1999 · DOI：10.7326/0003-4819-130-6-199903160-00005 · 被引用次数：621 · 研究领域：Asthma and respiratory diseases、Inhalation and Respiratory Drug Delivery、Respiratory and Cough-Related Research

BACKGROUND: Oral leukotriene receptor antagonists have been shown to have efficacy in chronic asthma. OBJECTIVE: To compare the clinical benefit of montelukast, a once-daily oral leukotriene receptor antagonist; placebo; and inhaled beclomethasone. DESIGN: Randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study. SETTING: 36 sites worldwide. PATIENTS: 895 patients 15 to 85 years of age with chronic asthma and an FEV1 50% to 85% of predicted. INTERVENTIONS: Montelukast, 10 mg once daily at bedtime; inhaled beclomethasone, 200 microg twice daily, administered with a spacer device; or placebo. MEASUREMENTS: Primary end points were daytime asthma symptom score and FEV1. Secondary end points were peak expiratory flow rates in the morning and evening, as-needed beta-agonist use, nocturnal awakenings, asthma-specific quality of life, and worsening asthma episodes. RESULTS: Over the 12-week treatment period, the average percentage change from baseline in FEV1 was 13.1% with beclomethasone, 7.4% with montelukast, and 0.7% with placebo (P < 0.001 for each active treatment compared with placebo; P < 0.01 for beclomethasone compared with montelukast). The average change from baseline in daytime symptom score was -0.62 for beclomethasone, -0.41 for montelukast, and -0.17 for placebo (P < 0.001 for each active treatment compared with placebo; P < 0.01 for beclomethasone compared with montelukast). Each agent improved peak expiratory flow rates and quality o...