Clinical trial NCT06339450: Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects
Official title: Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cystic Fibrosis, Pulmonary
Keywords: cystic fibrosis
Environmental Exposure
exhaled breath condansate
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase
level of hexanal
level of Neutrophil Elastase
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: Inclusion Criteria:

* Normal blood test
* Negative Cotinine test
* Protocole (RiPH2)
* Normal ECG
* Normal alcohol test
* Lung function with FEV1 predicted ≥ 40% at spirometry.

Exclusion Criteria:

* None

Primary outcomes:
measure: Collection of exhaled breath condensate (EBC) for biomarker analysis
timeFrame: day 1
measure: Collection of exhaled breath condensate (EBC) for biomarker analysis
timeFrame: days 3
measure: Collection of exhaled breath condensate (EBC) for biomarker analysis
timeFrame: days 5
measure: Collection of exhaled breath condensate (EBC) for biomarker analysis
timeFrame: days 6
measure: Collection of exhaled breath condensate (EBC) for biomarker analysis
timeFrame: days 8
measure: Collection of exhaled breath condensate (EBC) for biomarker analysis
timeFrame: days 10
Secondary outcomes:
measure: Dysfunction or misused, failure, of EBC and sensor device
timeFrame: days 10
measure: Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients.
timeFrame: days 5
measure: Describe differences in CF subjects vs. healthy controls
timeFrame: days 5
measure: Impact of environment exposome on health status and lung function
timeFrame: days 5
measure: Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients.
timeFrame: days 10
measure: Describe differences in CF subjects vs. healthy controls
timeFrame: days 10
Other outcomes:
Locations:
Study officials:
affiliation: CHI CRETEIL
name: ralph Epaud
role: PRINCIPAL_INVESTIGATOR
References: