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NOT YET RECRUITING
NCT06339450
NA

Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects

Sponsor: Centre Hospitalier Intercommunal Creteil

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2025-12-01

Completion Date

2027-12-01

Last Updated

2025-11-17

Healthy Volunteers

Yes

Interventions

OTHER

walk tours

* During 5 days the patient will walk 4 hours in urban green space (open-space areas reserved for parks and other "green spaces", including plant life, water features -also referred to as blue spaces and other kinds of natural environment). The 3 hours walk tour includes a lunch break of one hour in the green space. * During 5 days the patient will walk 4 hours in urban space (including 3 hours walk around the city and one-hour lunch break.