Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects
- Conditions
- Cystic Fibrosis, Pulmonary
- Interventions
- Other: walk tours
- Registration Number
- NCT06339450
- Lead Sponsor
- Centre Hospitalier Intercommunal Creteil
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 16
- Normal blood test
- Negative Cotinine test
- Protocole (RiPH2)
- Normal ECG
- Normal alcohol test
- Lung function with FEV1 predicted ≥ 40% at spirometry.
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cystic fibrosis patients walk tours cystic fibrosis patient Patient Control walk tours patient without cystic fibrosis
- Primary Outcome Measures
Name Time Method Collection of exhaled breath condensate (EBC) for biomarker analysis days 10 Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
- Secondary Outcome Measures
Name Time Method Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients. days 10 Correlation of environmental exposome signal biomark
Describe differences in CF subjects vs. healthy controls days 10 Comparison of environmental exposome signal biomarker and environmental sensor measures in healthy individuals and CF patients
Impact of environment exposome on health status and lung function days 5 Lung function testing and health questionnaire score before and after working trial in urban and green zone
Dysfunction or misused, failure, of EBC and sensor device days 10 rate of Dysfunction or misused, failure, of EBC and sensor device