Exhaled Breath Analysis by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS) in Adults With Cystic Fibrosis: An Exploratory Matched Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Molecular composition of exhaled breath analysed by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS)
研究概览
简要总结
Exploratory comparative evaluation of exhaled breath composition in cystic fibrosis patients with age and gender-matched healthy adults in order to identify a disease-specific exhaled breath pattern as well as to gain insight into pathophysiological and microbial contributions to exhaled breath composition.
详细描述
Although there is some evidence that breath composition reflects aspects of CF pathology, so far a disease-specific molecular breath profile has not been identified. Real-time, whole breath analysis incorporating all of the thousands of potentially relevant volatile compounds is needed in order to identify reliable CF-specific breath patterns. These may be used in future clinical applications to greatly enhance cost-effectiveness and simplicity of diagnostic testing for CF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of cystic fibrosis (for CF-patients)
- •Age ≥ 18 years
排除标准
- •Previous lung transplantation (for CF-patients)
- •Pulmonary exacerbation within the preceding 6 weeks (for CF-patients)
- •Moribund or severe disease prohibiting protocol adherence (for CF-patients)
- •Respiratory illness requiring physician consultation within the preceding 6 weeks (for controls)
- •Chronic respiratory illness (for controls)
- •Physical or intellectual impairment precluding informed consent or protocol adherence
- •Pregnancy
结局指标
主要结局
Molecular composition of exhaled breath analysed by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS)
时间窗: up to 2 years
Breathprints (exhalome) molecular composition expressed in intensity patterns (so-called mass-to-charge or m/z pairs)
次要结局
- Composite of clinical records(up to 2 years)