van Adelsberg Janet, Moy James, Wei Lynn X, Tozzi Carol A, Knorr Barbara, Reiss Theodore F
Merck Research Laboratories, Rahway, NJ 07065, USA.
Curr Med Res Opin. 2005 Jun;21(6):971-9. doi: 10.1185/030079905X48456.
The purpose of this study was to determine the safety and tolerability profile of montelukast 4-mg oral granules compared with placebo in children aged 6-24 months with asthma.
This was a randomized, double-blind, placebo-controlled, parallel-group study. Children 6-24 months of age at first visit with a history of at least three episodes of physician-diagnosed asthma or 'asthma-like' symptoms and in need of controller therapy were randomized to either montelukast 4-mg oral granules or placebo once daily in the evening for 6 weeks. The primary variables were the frequency of clinical and laboratory adverse experiences. The exploratory efficacy endpoints included days without beta-agonist use, beta-agonist use per day, unscheduled physician or hospital visits for asthma, oral corticosteroid rescues for asthma, asthma attacks, discontinuation due to worsening of asthma, and total blood peripheral eosinophil counts.
The most common clinical adverse experiences were upper respiratory tract infection, asthma, fever, diarrhea, and vomiting occurring with similar frequencies between treatment groups. There were no clinically meaningful differences between the two treatment groups in clinical or laboratory adverse experiences and no significant differences in frequency of patients with elevated serum transaminases. Differences between the montelukast and placebo treatment groups in the exploratory efficacy endpoints of days without beta-agonist use, oral corticosteroid rescues, emergency care, asthma attacks, and discontinuations due to worsening asthma were not significant.
Montelukast, 4-mg oral granules, was well tolerated over 6 weeks of treatment in children aged 6-24 months with asthma.
本研究旨在确定与安慰剂相比，4毫克孟鲁司特口服颗粒剂在6至24个月哮喘儿童中的安全性和耐受性。
这是一项随机、双盲、安慰剂对照、平行组研究。首次就诊时年龄在6至24个月、有至少三次医生诊断为哮喘或“哮喘样”症状病史且需要控制治疗的儿童，被随机分为每晚一次服用4毫克孟鲁司特口服颗粒剂或安慰剂，为期6周。主要变量为临床和实验室不良事件的发生频率。探索性疗效终点包括无β受体激动剂使用天数、每日β受体激动剂使用量、因哮喘进行的非计划医生就诊或住院次数、哮喘的口服糖皮质激素挽救治疗、哮喘发作、因哮喘恶化而停药以及外周血嗜酸性粒细胞总数。
最常见的临床不良事件是上呼吸道感染、哮喘、发热、腹泻和呕吐，治疗组之间的发生频率相似。两组在临床或实验室不良事件方面无临床意义上的差异，血清转氨酶升高患者的频率也无显著差异。孟鲁司特和安慰剂治疗组在无β受体激动剂使用天数、口服糖皮质激素挽救治疗、急诊、哮喘发作以及因哮喘恶化而停药等探索性疗效终点方面的差异不显著。
在6至24个月哮喘儿童中，4毫克孟鲁司特口服颗粒剂在6周治疗期间耐受性良好。
