Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- post-treatment fractional exhaled nitric oxide
研究概览
简要总结
Leukotriene receptor antagonists (LTRAs) reduce fractional exhaled nitric oxide (FENO) concentrations in children with asthma, but the effect of LTRA withdrawal on FENO and lung function is unknown. We will aim to study the effect of treatment and withdrawal of montelukast, a LTRA, on airway inflammation as reflected by FENO and lung function in children with asthma.
A double-blind, randomized, placebo controlled, parallel group study will be undertaken in 18 atopic children with mild persistent asthma who will be treated with oral montelukast (5 mg/day for 4 weeks) and 18 atopic children with mild persistent asthma who will receive matching placebo.
A follow-up visit will be performed 2 weeks after montelukast or placebo withdrawal.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 6 to 14 yrs old, step 1 and step 2 GINA (Global INitiative for Asthma) guidelines
- •exhaled nitric oxide (NO) >20 PPB at visit 2
- •symptoms more often than twice a day, FEV1 equal or higher than 80% of predicted value and reversibility equal or higher than 12% to salbutamol, or a positive provocation test with methacholine, or exercise
- •no regular medication, inhaled short-acting beta-2 agonists for symptom relief
排除标准
- •Patient is hospitalized
- •Patient has FEV1 < 80% predicted on visit 1
- •Patient has 2 or more nighttime awakenings for asthma per week or pef variability 30% or more
- •upper respiratory infection in the previous 3 weeks
- •treatment with glucocorticoids or LTRAs in the previous 4 weeks
- •treatment with inhaled glucocorticoids for more than 4 weeks in the previous year
研究组 & 干预措施
1
干预措施: montelukast sodium (Drug)
2
干预措施: placebo (Drug)
结局指标
主要结局
post-treatment fractional exhaled nitric oxide
次要结局
- fractional exhaled nitric oxide 2 weeks after montelukast withdrawal
- post-treatment FEV1
- post-treatment FVC
- post-treatment FEV1/FVC
- post-treatment FEF25%-75%
- FEV1 2 weeks after montelukast withdrawal
- FVC 2 weeks after montelukast withdrawal
- FEV1/FVC 2 weeks after montelukast withdrawal
- FEF25%-75% 2 weeks after montelukast withdrawal
- asthma exacerbation rate