Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects

Environmental Exposure Clinical Trial

— ExpoCF  

Official title:

Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06339450
• Other study ID #: ExpoCF
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: camille Jung
• Phone: 0157022268
• Email: camille.jung[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 31, 2027
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis, Pulmonary
• Environmental Exposure
• Fibrosis
• Pulmonary Fibrosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of exhaled breath condensate (EBC) for biomarker analysis	Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC	day 1
Primary	Collection of exhaled breath condensate (EBC) for biomarker analysis	Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC	days 3
Primary	Collection of exhaled breath condensate (EBC) for biomarker analysis	Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC	days 5
Primary	Collection of exhaled breath condensate (EBC) for biomarker analysis	Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC	days 6
Primary	Collection of exhaled breath condensate (EBC) for biomarker analysis	Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC	days 8
Primary	Collection of exhaled breath condensate (EBC) for biomarker analysis	Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC	days 10
Secondary	Dysfunction or misused, failure, of EBC and sensor device	rate of Dysfunction or misused, failure, of EBC and sensor device	days 10
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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