NCT02097537已完成3 期
Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL
研究概览
简要总结
The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation challenge in children with bronchial asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bronchial asthma
- •FEV1/FVC must be 70% or more
- •<10% decrease in FEV1 in response to inhalation of normal saline
排除标准
- •Moderate or severe airflow limitation（FEV1<60% predicted）
- •Heart attack or stroke in last 3 months
- •Uncontrolled hypertension, systolic BP>200, or diastolic BP>100
- •known aortic aneurysm
研究组 & 干预措施
Methacholine Chloride
Experimental
children with bronchial asthma
干预措施: Methacholine Chloride (SK-1211) (Drug)
结局指标
主要结局
The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL
时间窗: Visit 1 (Day 1)
The methacholine challenge test is for assessment of bronchial sensitivity, it is assessed by FEV1 (Forced Expiratory Volume in one second) with spirometer. For measurement of FEV1, a patient is inhaled saline as baseline and each dose of methacholine which be gradually diluted, inhalations are discontinued with a drop in FEV1 of 20% or more. The concentration of methacholine causing 20% fall in FEV1 is PC20.
次要结局
- The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation(Visit 1 (Day 1))
- The Summary Statistics of PC20(Visit 1 (Day 1))
研究者
研究点 (1)
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