Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06339450 (ExpoCF) for Cystic Fibrosis, Pulmonary is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects (ExpoCF) 16 Biomarker-Driven Real-World Evidence
Clinical Trial NCT06339450 (ExpoCF) is an interventional study for Cystic Fibrosis, Pulmonary and is currently not yet recruiting. Enrollment is planned to begin on 1 December 2025 and continue until the study accrues 16 participants. Led by Centre Hospitalier Intercommunal Creteil, this study is expected to complete by 1 December 2027. The latest data from ClinicalTrials.gov was last updated on 17 November 2025.
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 incr...Show More
Official Title
Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects
Conditions
Cystic Fibrosis, PulmonaryOther Study IDs
- ExpoCF
NCT ID Number
Start Date (Actual)
2025-12-01
Last Update Posted
2025-11-17
Completion Date (Estimated)
2027-12-01
Enrollment (Estimated)
16
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
cystic fibrosis
Environmental Exposure
exhaled breath condansate
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase
level of hexanal
level of Neutrophil Elastase
Environmental Exposure
exhaled breath condansate
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase
level of hexanal
level of Neutrophil Elastase
Primary Purpose
Other
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCystic fibrosis patients cystic fibrosis patient | 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 a...Show More |
ExperimentalPatient Control patient without cystic fibrosis | 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 a...Show More |
Primary Outcome Measures
Secondary 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 |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Normal blood test
- Negative Cotinine test
- Protocole (RiPH2)
- Normal ECG
- Normal alcohol test
- Lung function with FEV1 predicted ≥ 40% at spirometry.
- None
Centre Hospitalier Intercommunal CreteilStudy Central Contact
Contact: camille Jung, 0157022268, [email protected]
No location data.