Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Lung function test (flow and resistance)
研究概览
简要总结
In this study children with recurrent wheezing (>/= 2 episodes in the last 6 months)and aged less than 2 years will be enrolled as outpatients. They will undergo lung function evaluation by Rint and by assessment of the flow curves at baseline and after 4 weeks of treatment with Montelukast 4 mg/day. Symptom dairies will be filled by parents during the study period.
详细描述
Patients aged less than 2 years with recurrent wheezing. At visit 1 patients with symptoms will be enrolled and the study explained. They will return home with bronchodilator therapy.
Within 1 week they will return for visit 2 to start a run-in period with bronchodilators prn and they will fill dairies with symptoms and drug use. Skin prick test will be evaluated at that time.
At visit 3 after 1 week of the run-in period they will start therapy with Montelukast 4 mg for 4 weeks, using bronchodilators prn and filling diaries.
The final visit will be after four weeks with re-evaluation of the lung function
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 6-24 months
- •Patients with recurrent wheezing (at least 2 episodes in the last 6 months)
- •Patients with symptoms at enrollment
排除标准
- •Chronic respiratory diseases (cystic fibrosis, chronic lung disease) symptoms at visit 1 that require hospital admission
研究组 & 干预措施
Montelukast
the single arm will receive montelukast
干预措施: Montelukast (Drug)
结局指标
主要结局
Lung function test (flow and resistance)
时间窗: 4 weeks
次要结局
- Bronchodilator use Dairy symptoms(4 weeks)
研究者
Boner Attilio
Prof
Universita di Verona