Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects

NCT06339450 | Not Yet Recruiting

• 1 other identifier: ExpoCF
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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

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

Outcome Measures

Primary Outcomes (6)

• Collection of exhaled breath condensate (EBC) for biomarker analysis

  Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC

  day 1

• Collection of exhaled breath condensate (EBC) for biomarker analysis

  Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC

  days 3

• Collection of exhaled breath condensate (EBC) for biomarker analysis

  Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC

  days 5

• Collection of exhaled breath condensate (EBC) for biomarker analysis

  Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC

  days 6

• Collection of exhaled breath condensate (EBC) for biomarker analysis

  Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC

  days 8

• Collection of exhaled breath condensate (EBC) for biomarker analysis

  Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC

  days 10

Secondary Outcomes (6)

• Dysfunction or misused, failure, of EBC and sensor device

  days 10

• Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients.

  days 5

• Describe differences in CF subjects vs. healthy controls

  days 5

• Impact of environment exposome on health status and lung function

  days 5

• Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients.

  days 10

Study Arms (2)

Cystic fibrosis patients

EXPERIMENTAL

cystic fibrosis patient

Other: walk tours

Patient Control

EXPERIMENTAL

patient without cystic fibrosis

Other: walk tours

Interventions

walk tours OTHER

* 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.

Cystic fibrosis patients; Patient Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• ralph Epaud

  CHI CRETEIL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

camille Jung

CONTACT

0157022268; camille.jung@chicreteil.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-10