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Significant difficulties in recruiting participants, particularly in the 'cystic fibrosis' group.The constraints placed on participants, in particular the requirement to walk for ten days (5 days in an urban area and 5 days in a green area)
ExpoCF
Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 25, 2024
Actual (reported)April 1, 2024
Actual (reported)December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
cystic fibrosis patient
patient without cystic fibrosis
* 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
ralph Epaud
CHI CRETEIL
0 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2024
First Posted
April 1, 2024
Study Start
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Contact the study team to confirm eligibility.
Primary Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 16, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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