Bronchial Inflammation of Small Airways in Patients With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Bronchial Inflammation in sputum of patients with CF
研究概览
简要总结
In the planned study, 60 patients with mild cystic fibrosis (CF) with and without the involvement of small airways (small airway disease - SAD) are to be compared with a historical control group matched in age and gender. During the first study visit subjects are asked to perform a pulmonary function test (spirometry, body plethysmography with helium, determination of "Trapped Air") and exhaled nitric oxide (eNO) and exhaled carbon monoxide (eCO) measurements will be done in exhaled air. In addition, a blood sample is drawn to describe inflammatory status. Sputum is induced as well. During the second study visit, a non-specific bronchial provocation test(methacholine PD20 FEV1) is performed.
The aim of the study is to get a characterization of the bronchial and systemic inflammation (IL-1ß, IL-6, IL-8, IL-17, TNF-α, NFKB, and recognition structures like TLR2 and TLR4) in CF patients with and without the involvement of the small airways, which may point to new treatment strategies.
详细描述
Aim of this study is the characterization of patients with mild cystic fibrosis in terms of lung function, bronchial hyperreactivity and the degree of systemic and bronchial inflammation.
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction(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 order to support the analyzed lung function and sputum/ serum biomarker data the investigators will also rely on pre-existing imaging data like chest x-rays or high-resolution computer tomography (HRCT)of the lungs.
Methods and Work Programme:
This study consists of two study visits (V1 and V2)
V1:
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent
- •confirmed diagnosis of CF (known mutations and/or sweat chloride test > 60mval/l)
- •age between 6 and 60 years
- •vital capacity > 75%
- •Ability to perform lung function tests and inhalation
排除标准
- •< 6 and > 60 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
结局指标
主要结局
Bronchial Inflammation in sputum of patients with CF
时间窗: 24 months
Measuring IL-8 in induced sputum compared to induced sputum of age matched controls
次要结局
- Inflammatory proteins like (Il-1,IL-6, TNF alpha) in induced sputum(24 months)
研究者
Stefan Zielen
Professor Dr. med. Stefan Zielen
Johann Wolfgang Goethe University Hospital