Bronchial Provocation Tests With House Dust Mite in Allergic Asthma in Guangzhou
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- percentages of the participants that tested positive to house dust mites bronchial provocation
研究概览
简要总结
The purpose of this study is to establish the methodology of bronchial provocation tests with house dust mites in China, and to evaluate its safety and effects on upper and lower airways inflammation.
详细描述
After screening,each participant undergo baseline lung function test,airway inflammation evaluation (blood and sputum eosinophils count,interleukin-13 (IL-13),FeNO)and airway responsiveness tests(methacholine bronchial provocation,nasal histamine provocation).
On the second day,the participant undergo bronchial house dust mites challenge tests.
On the third day,the participant undergo the lung function test,airway inflammation evaluation (blood and sputum eosinophils count,IL-13,FeNO)and airway responsiveness tests(methacholine bronchial provocation,nasal histamine provocation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of asthma;
- •Sensitive to house dust mite;
- •Stable for more than 4 weeks with FEV1≥70%pred
排除标准
- •exacerbation within 3 months;
- •upper airway infections within 6 weeks;
- •concomitant of hypertension or heart diseases;
- •pregnancy
研究组 & 干预措施
allergic asthma
asthma patients that sensitive to house dust mites.
干预措施: house dust mites (Other)
normal controls
normal controls with or without sensitive to house dust mites.
干预措施: house dust mites (Other)
结局指标
主要结局
percentages of the participants that tested positive to house dust mites bronchial provocation
时间窗: 30 minutes after house dust mites bronchial provocation
次要结局
- percentages of the participants that tested positive to house dust mites bronchial provocation measured by impulse oscillometry(10 minutes after house dust mites bronchial provocation)
- Changes of provocative concentration induced a 60% increase in nasal airway resistance to histamine before and after house dust mites bronchial provocation(24 hours after house dust mites bronchial challenge)
- Changes of the percentages of eosinophils in sputum, nasal lavage and fractional exhaled nitric oxide (FeNO) from baseline(30mins, 7 and 24 hours after bronchial challenge)
- Changes of provocative concentration induced a 20% decrease in forced expiratory volume at one second (FEV1) to methacholine before and after house dust mites bronchial provocation(24 hours after house dust mites bronchial challenge)
研究者
Jinping Zheng
Deputy director,GRID
Guangzhou Institute of Respiratory Disease