Lungfunction, Lung Clearance Index, Bronchial Inflammation and Epigenetics of Patients With Bronchiolitis Obliterans
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- miRNA Status
研究概览
简要总结
Bronchiolitis obliterans is a chronic disease in which a persistent inflammatory process leads to obliteration of the small airways. Pulmonary function tests (body plethysmography with DLCO, lung clearance index) are performed and the fraction of exhaled nitric oxide is measured. A blood test is following to determine the inflammatory status und collect miRNA. Induced Sputum will be obtained.
详细描述
The purpose of this study is to compare miRNA pattern, lung function values, bronchial inflammation and the Lung clearance index of Patients with Bronchiolitis obliterans aged between 6 up to 30 years of age with a matched control group.
The sputum samples will be processed and quantitatively analyzed to get a profile of the cytological composition.
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (qRT-PCR) and by cytometric bead assay (CBA). miRNA samples will be collected, processand compared with the miRNA database at http://www.mirbase.org/
Methods and Work Programme:
- Measurement of nitric oxide in expired air (FeNO)
- Lung function testing with spirometry and body plethysmography
- Lung clearance index (LCI)
- Bronchodilation
- Blood test: blood count, CRP, RAST, serum inflammatory mediators, (genetic markers of the non-specific pulmonary defense system), miRNA analysis
- Induced sputum for inflammatory mediators and microbiological investigations
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
- 6 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent
- •age between 6 an 35 years
- •known bronchiolitis obliterans (Group Bronchiolitis)/ no Bronchiolitis Obliterans (Group matched controls)
- •ability to perform lung function tests and inhale correctly
排除标准
- •<6 years of age
- •>35 years of age
- •acute systemic or bronchial inflammation
- •other chronic diseases or infection (e.g. HIV, Tbc, malignoma)
- •pregnancy
- •alcohol, drug or illegal drug abuse
- •disability to register the range and consequences of the study
- •actual participation in another study
结局指标
主要结局
miRNA Status
时间窗: single day observation
Blood sample to determine candidate miRNA for Bronchiolitis obliterans
次要结局
未报告次要终点
研究者
Dr. med. Martin Rosewich
Principal Investigator
Johann Wolfgang Goethe University Hospital