Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects (ExpoCF)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Environmental Exposure; Cystic Fibrosis, Pulmonary; Exhaled Breath Condansate
• Intervention / Treatment: Other: walk tours

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camille JUNG; Phone Number: 0157022268; Email: camille.jung@chicreteil.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cystic fibrosis patients; cystic fibrosis patient	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.
Experimental: Patient Control; patient without cystic fibrosis	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysfunction or misused, failure, of EBC and sensor device	rate of 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.	Correlation of environmental exposome signal biomark	days 5
Describe differences in CF subjects vs. healthy controls	Comparison of environmental exposome signal biomarker and environmental sensor measures in healthy individuals and CF patients	days 5
Impact of environment exposome on health status and lung function	Lung function testing and health questionnaire score before and after working trial in urban and green zone	days 5
Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients.	Correlation of environmental exposome signal biomark	days 10
Describe differences in CF subjects vs. healthy controls	Comparison of environmental exposome signal biomarker and environmental sensor measures in healthy individuals and CF patients	days 10

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Investigators: Principal Investigator: ralph Epaud, CHI Créteil

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cystic fibrosis; Environmental Exposure; exhaled breath condansate; Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase; level of hexanal; level of Neutrophil Elastase
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: ExpoCF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No