NCT02100267已完成3 期
A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult 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
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL)
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult asthma
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FEV1/forced vital capacity(FVC) must be 70% or more
- •<10% decrease in FEV1 in response to inhalation of normal saline
排除标准
- •Moderate airflow limitation (FEV1 < 60% predicted or < 1.5 L)
- •Heart attack or stroke in last 3 months
- •Uncontrolled hypertension, systolic BP>200, or diastolic BP>100
研究组 & 干预措施
Asthma patients
Experimental
干预措施: Methacholine Chloride (SK-1211) (Drug)
Healthy volunteers
Experimental
干预措施: Methacholine Chloride (SK-1211) (Drug)
结局指标
主要结局
Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL)
时间窗: Visit 2 (Day 1)
Provocative concentration causing a 20% fall(PC20) will be captured once at visit 2.
次要结局
未报告次要终点
研究者
研究点 (1)
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