Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 16
- 主要终点
- Collection of exhaled breath condensate (EBC) for biomarker analysis
研究概览
简要总结
Cystic fibrosis (CF) is the most common autosomal recessive disease that leads to early mortality in Caucasians and affects around 7500 patients in France. Progression of the disease depends on pulmonary exacerbations defined as acute deterioration of respiratory symptoms which ultimately impair lung function and quality of life. Most frequently caused by lung bacterial infections, exacerbations' effects include increased cough, increased sputum production, increased use of antibiotics, dyspnea and decreased lung function. The phenotypic variability of CF suggests the implication of other contributors especially to the CF airway disease. Beside genetic and epigenetic alterations, environmental factors - e.g tobacco smoke, air pollution, temperature changes, food intake - appear as relevant candidates. A previous review has discussed current knowledge on the effects of air pollution on the course of CF disease. Although scarce, the existing epidemiological andexperimental literature suggests a link between exposure to air pollutants and adverse health effects.Although scarce, the existing epidemiological and experimental literature suggests a link between exposure to air pollutants and adverse health effects. The EU sponsored REMEDIA project (Impact of exposome on the course of lung diseases, Grant agreement ID 874753) contributes to the understanding of the influence of the exposome on chronic obstructive pulmonary disease (COPD) and CF. Objective of work package 3 within the REMEDIA project is the development of a mobile environmental sensor toolbox that is capable to assess the external exposome. The biomarkertoolbox was developed and tested in a proof-of-concept study carried out in healthy volunteers. The next step is to validate the collectionof exhaled breath condensate (EBC) in a real-life study. In this aim, the objective of the present study will be to assess the feasibility of EBC collection in CF patients and healthy individuals
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal blood test
- •Negative Cotinine test
- •Protocole (RiPH2)
- •Normal ECG
- •Normal alcohol test
- •Lung function with FEV1 predicted ≥ 40% at spirometry.
排除标准
- 未提供
研究组 & 干预措施
Cystic fibrosis patients
cystic fibrosis patient
干预措施: walk tours (Other)
Patient Control
patient without cystic fibrosis
干预措施: walk tours (Other)
结局指标
主要结局
Collection of exhaled breath condensate (EBC) for biomarker analysis
时间窗: days 10
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
次要结局
- Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients.(days 10)
- Describe differences in CF subjects vs. healthy controls(days 10)
- Impact of environment exposome on health status and lung function(days 5)
- Dysfunction or misused, failure, of EBC and sensor device(days 10)