NCT02450461已完成不适用
Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Patients With Asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome will be the asthma specific mass spectrometric profile of VOCs of exhaled breath analysis (markers of asthma in exhaled breath)
研究概览
简要总结
The purpose of this study is to answer the question whether a disease-specific profile of breath in patients with asthma can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed asthma. Diagnosis of asthma is made with episodic chest symptoms and a documented reversibility of at least 12% and/or 200 ml in FEV1 after 200 ug of inhaled salbutamol or airway hyperresponsiveness in the case of normal lung function testing (PC20 methacholine < 4mg/ml) at the time of diagnosis.
- •Age between 18 and 80 years at study entry.
- •Healthy controls: never-smokers, normal spirometry (baseline FEV1 > 85% predicted and FEV1/FVC greater than 0.7).
排除标准
- •Asthma exacerbation within the last 6 weeks, defined as worsening of asthma symptoms requiring a change in therapy by a physician or a change in regular asthma therapy (including short course of oral corticosteroids)
- •Any lung disease other than asthma.
- •Acute inflammatory disease (e.g. common cold) within the last 4 weeks.
- •Regular intake of oral steroids.
- •Active smoking habits / positive history of smoking.
- •Acute or chronic hepatic disease.
- •Renal failure or renal replacement therapy.
结局指标
主要结局
The primary outcome will be the asthma specific mass spectrometric profile of VOCs of exhaled breath analysis (markers of asthma in exhaled breath)
时间窗: 1 day, single measurement, no follow up
次要结局
未报告次要终点
研究者
研究点 (1)
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