A Multicenter, Open-Label, Controlled, Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 190
- 主要终点
- Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment
研究概览
简要总结
Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient successfully completed visit 5 of MK0476 Protocol 176 (NCT00943683)
- •Patient is in good, stable health
- •Patient has been fed solid foods for at least 1 month
- •Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit
- •Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines
排除标准
- •Patient was hospitalized at the start of the study or had any major surgery 4 weeks prior
- •Patient had an allergy to apples or applesauce
研究组 & 干预措施
1
Montelukast
干预措施: montelukast sodium (Drug)
结局指标
主要结局
Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment
时间窗: Up to 52 weeks of treatment
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
次要结局
未报告次要终点