Korean Study of "Real-World" Montelukast Use in Mild Asthmatic Children With Concomitant Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 191
- 主要终点
- Change From Baseline for Daytime Asthma Symptom Score
研究概览
简要总结
The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.
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
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 2 and 14 years old
- •Diagnosed with asthma, classified as mild persistent asthma according to Global Initiative Asthma Guidelines (GINA)
- •Diagnosed with comorbid allergic rhinitis
排除标准
- •Patients with suspected sinus infection
- •Prior treatment with high dose inhaled corticosteroid requiring a dose higher than beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in severe cases
研究组 & 干预措施
Montelukast
Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
干预措施: montelukast sodium (Drug)
Inhaled Corticosteroids (ICS)
Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
干预措施: inhaled corticosteroid (Drug)
结局指标
主要结局
Change From Baseline for Daytime Asthma Symptom Score
时间窗: Baseline and Week 12
The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.
次要结局
- Change From Baseline for Daily Allergic Rhinitis Symptom Score(Baseline and Week 12)