Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects

NCT ID: NCT06339450

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cystic fibrosis patients

cystic fibrosis patient

Group Type: EXPERIMENTAL

walk tours

Intervention Type: 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.

Patient Control

patient without cystic fibrosis

Group Type: EXPERIMENTAL

walk tours

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ralph Epaud

Role: PRINCIPAL_INVESTIGATOR

CHI CRETEIL

Central Contacts

camille Jung

Role: CONTACT

camille.jung@chicreteil.fr

0157022268

Other Identifiers

ExpoCF

Identifier Type: -

Identifier Source: org_study_id