Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The aim of this case-control study is the characterization of the bronchial and systemic inflammation of children and young adults with bronchiolitis obliterans.
On the first visit subjects are asked to perform a lung function test (spirometry, body plethysmography with helium). Further levels of eNO and eCO are determined. A blood sample is drawn to describe the inflammatory status. Bronchial inflammation will be measured in induced sputum. At the second visit, a non-specific bronchial provocation testing (PD20 FEV1 methacholine) is performed.
详细描述
Objectives:
The aim of this study is the characterization of patients with bronchiolitis obliterans in terms of lung function, bronchial hyperreactivity and the degree of the systemic and bronchial inflammation.
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) and by cytometric bead assay (CBA). Components of the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant proteins) are genetically determined from sputum or blood respectively. In the conduct of this study the investigators will retrospectively and systematically evaluate the available high-resolution computed tomography (HRCT) studies of affected patients
Methods and Work Programme:
This study consists of two study visits (V1 and V2)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent
- •between 6 and 25 years of age
- •Known bronchiolitis obliterans / no bronchiolitis obliterans(depending on the study group)
- •Ability to perform lung function tests and inhalation
排除标准
- •<6 and > 25 years of age on the day of written informed consent
- •Acute illness with systemic or bronchial inflammation
- •every chronic condition or infection (eg HIV, tuberculosis, malignancy)
- •pregnancy
- •known alcohol and/ or drug abuse
- •Inability to understand the extent and scope of the study
- •Participation in another study
研究者
Dr. med. Martin Rosewich
Martin Rosewich, MD
Johann Wolfgang Goethe University Hospital