Comparison of 2-min Tidal Breathing Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- percentage of the participants that tested positive to methacholine bronchial provocation with Wright or Devilbiss646 nebulizer
研究概览
简要总结
The purpose of this study is to compare the diagnostic validity (sensitivity and specificity) and evaluate the safety of 2-min Tidal Breathing methacholine bronchial provocation tests with the Wright and Devilbiss646 nebulizers in asthmatic in Guangzhou.
详细描述
After screening,each asthmatic patient will visit the investigators' center 4 times.
During the first week, the patient will be randomised to undergo methacholine bronchial challenge with Wright or Devilbiss 646 nebulizer on two separate days, which are at least 24 hours but not more than 7 days apart.The above procedure will be repeated for each patient in one month. But the nebulizer will be selected in a reverse order.Provocative concentration induced a 20% decrease in forced expiratory volume in one second (PC20) will be calculated for each test. Record all the adverse events during the tests.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinical diagnosis of asthma;
- •stable for more than 4 weeks with FEV1≥65%pred
排除标准
- •exacerbation within 3 months;
- •upper airway infections within 4 weeks;
- •concomitant of hypertension or heart diseases;
- •pregnancy;
- •under immunotherapy
研究组 & 干预措施
asthma
methacholine(0.031-16mg/ml) bronchial provocation tests. this is a crossover,normal-control study. nebulized with Wright nebulizer for 2 minutes with an output of 0.13ml/min.
干预措施: Wright Nebulizer (Device)
asthma
methacholine(0.031-16mg/ml) bronchial provocation tests. this is a crossover,normal-control study. nebulized with Wright nebulizer for 2 minutes with an output of 0.13ml/min.
干预措施: Devilbiss646 Nebulizer (Device)
normal controls
methacholine(0.031-16mg/ml) bronchial provocation tests. this is a crossover,normal-control study. nebulized with Devilbiss646 nebulizer for 2 minutes with an output of 0.13ml/min
干预措施: Wright Nebulizer (Device)
normal controls
methacholine(0.031-16mg/ml) bronchial provocation tests. this is a crossover,normal-control study. nebulized with Devilbiss646 nebulizer for 2 minutes with an output of 0.13ml/min
干预措施: Devilbiss646 Nebulizer (Device)
normal controls
methacholine(0.031-16mg/ml) bronchial provocation tests. this is a crossover,normal-control study. nebulized with Devilbiss646 nebulizer for 2 minutes with an output of 0.13ml/min
干预措施: methacholine (Other)
asthma
methacholine(0.031-16mg/ml) bronchial provocation tests. this is a crossover,normal-control study. nebulized with Wright nebulizer for 2 minutes with an output of 0.13ml/min.
干预措施: methacholine (Other)
结局指标
主要结局
percentage of the participants that tested positive to methacholine bronchial provocation with Wright or Devilbiss646 nebulizer
时间窗: 5 minutes after each challenge
次要结局
- Incidence and severity of Adverse Events during the methacholine bronchial provocation tests with Wright nebulizer and Devilbiss646 nebulizer(during and until 5 minutes after each challenge)
研究者
Jinping Zheng
deputy director
Guangzhou Institute of Respiratory Disease