Papadopoulos Nikolaos G, Philip George, Giezek Hilde, Watkins Molly, Smugar Steven S, Polos Peter G
Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece.
J Asthma. 2009 May;46(4):413-20. doi: 10.1080/02770900902847727.
To determine the effect of montelukast on asthma during the allergy season in children with persistent asthma and seasonal aeroallergen sensitivity.
This 3-week double-blind, placebo-controlled, parallel-group multicenter study compared daily montelukast 5 mg chewable tablets and placebo in patients 6-14 years of age with forced expiratory volume in 1 second (FEV(1)) > or = 60 and < or = 85% predicted, persistent asthma that is also active during allergy season, and documented sensitivity to seasonal allergens. Concomitant inhaled corticosteroid use was permitted in up to 40% of enrolled patients. The primary endpoint was the percentage change from baseline in FEV(1) over 3 weeks of treatment. Additional endpoints included the percentage change from baseline in beta-agonist use, average changes in daytime and nighttime symptom score, AM and PM peak expiratory flow rate (PEFR), investigator's global asthma evaluation, and parent/guardian global asthma evaluation at the end of the treatment period. Adverse experiences (AEs) were collected to assess safety and tolerability.
A total of 421 patients were randomized to montelukast (N = 203) or placebo (N = 218). For the primary endpoint, the percentage change from baseline FEV(1), montelukast was not significantly different from placebo (least squares mean 9.53% vs. 9.15%, respectively; p = 0.810). Compared with placebo, montelukast was associated with significantly lower (better) investigator's global asthma evaluation (LS mean 2.71 vs. 2.98; p < 0.05) and parent/guardian global asthma evaluation (LS mean: 2.63 vs. 2.90; p < 0.05) scores. There were no significant differences between treatment groups for the other efficacy evaluations. Both treatments were well tolerated, with no significant differences observed in AE rates.
Montelukast did not significantly improve FEV(1) compared with placebo over three weeks of treatment during the allergy season in pediatric patients with seasonal allergen sensitivity. (ClinicalTrials.gov identifier: NCT00289874).
确定孟鲁司特对患有持续性哮喘且对季节性空气变应原敏感的儿童在过敏季节哮喘的影响。
这项为期3周的双盲、安慰剂对照、平行组多中心研究，比较了6至14岁、第1秒用力呼气量（FEV₁）≥预计值的60%且≤85%、患有在过敏季节也活跃的持续性哮喘且有记录表明对季节性变应原敏感的患者，每日服用5毫克孟鲁司特咀嚼片与安慰剂的效果。入组患者中高达40%允许同时使用吸入性糖皮质激素。主要终点是治疗3周内FEV₁相对于基线的百分比变化。其他终点包括β受体激动剂使用量相对于基线的百分比变化、白天和夜间症状评分的平均变化、上午和下午的呼气峰值流速（PEFR）、研究者对哮喘的整体评估以及治疗期末家长/监护人对哮喘的整体评估。收集不良事件（AE）以评估安全性和耐受性。
共有421例患者被随机分为孟鲁司特组（N = 203）或安慰剂组（N = 218）。对于主要终点，即FEV₁相对于基线的百分比变化，孟鲁司特与安慰剂无显著差异（最小二乘均值分别为9.53%和9.15%；p = 0.810）。与安慰剂相比，孟鲁司特与研究者对哮喘的整体评估得分显著更低（更好）（最小二乘均值2.71对2.98；p < 0.05）以及家长/监护人对哮喘的整体评估得分显著更低（更好）（最小二乘均值：2.63对2.90；p < 0.05）。在其他疗效评估方面，治疗组之间无显著差异。两种治疗耐受性均良好，不良事件发生率无显著差异。
在过敏季节，对于对季节性变应原敏感的儿科患者，治疗3周期间，与安慰剂相比，孟鲁司特未显著改善FEV₁。（ClinicalTrials.gov标识符：NCT00289874）
