Cystic Fibrosis, PulmonaryExpoCFNCT06339450
Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects
A study testing walk tours in people with Cystic Fibrosis, Pulmonary, run by Centre Hospitalier Intercommunal Creteil.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Pulmonary
- What is being tested?
- walk tours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal blood test
- Negative Cotinine test
- Protocole (RiPH2)
- Normal ECG
- Normal alcohol test
- Lung function with FEV1 predicted ≥ 40% at spirometry.
Who cannot join
- None
About this study
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
- Being tested
- walk tours
- Keywords
- cystic fibrosis, Environmental Exposure, exhaled breath condansate, Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase, level of hexanal, level of Neutrophil Elastase
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walk toursOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis patients | Experimental | cystic fibrosis patient Receives: Other: walk tours |
| Patient Control | Experimental | patient without cystic fibrosis Receives: Other: walk tours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of exhaled breath condensate (EBC) for biomarker analysis
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
Measured: day 1
Collection of exhaled breath condensate (EBC) for biomarker analysis
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
Measured: days 3
Collection of exhaled breath condensate (EBC) for biomarker analysis
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
Measured: days 5
Collection of exhaled breath condensate (EBC) for biomarker analysis
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
Measured: days 6
Collection of exhaled breath condensate (EBC) for biomarker analysis
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
Measured: days 8
Collection of exhaled breath condensate (EBC) for biomarker analysis
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
Measured: days 10
Secondary outcomes (6)
Dysfunction or misused, failure, of EBC and sensor device
rate of Dysfunction or misused, failure, of EBC and sensor device
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: days 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Why it stopped: 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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ralph Epaud, Principal investigator, CHI CRETEIL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339450
- Sponsor's protocol ID
- ExpoCF
- Acronym
- ExpoCF
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects
- ClinicalTrials.gov ID
- NCT06339450
- Acronym / sponsor ID
- ExpoCF / ExpoCF
- Conditions
- Cystic Fibrosis, Pulmonary
- Keywords
- cystic fibrosis, Environmental Exposure, exhaled breath condansate, Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase, level of hexanal, level of Neutrophil Elastase
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 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)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis patients | Experimental | Other: walk tourscystic fibrosis patient |
| Patient Control | Experimental | Other: walk tourspatient without cystic fibrosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Normal blood test
- Negative Cotinine test
- Protocole (RiPH2)
- Normal ECG
- Normal alcohol test
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Cystic fibrosis patients, Patient Control |
Primary outcome
Collection of exhaled breath condensate (EBC) for biomarker analysis
Time frame: day 1
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
Collection of exhaled breath condensate (EBC) for biomarker analysis
Time frame: days 3
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
Collection of exhaled breath condensate (EBC) for biomarker analysis
Time frame: days 5
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
Collection of exhaled breath condensate (EBC) for biomarker analysis
Time frame: days 6
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
Collection of exhaled breath condensate (EBC) for biomarker analysis
Time frame: days 8
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
Collection of exhaled breath condensate (EBC) for biomarker analysis
Time frame: days 10
Levels of 3-Nitrotyrosin, Hexanal, Neutrophil Elastase in EBC
6 secondary outcomes
Dysfunction or misused, failure, of EBC and sensor device
Time frame: days 10
Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients.
Time frame: days 5
Describe differences in CF subjects vs. healthy controls
Time frame: days 5
Impact of environment exposome on health status and lung function
Time frame: days 5
Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients.
Time frame: days 10
Describe differences in CF subjects vs. healthy controls
Time frame: days 10
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
Related trials for Cystic Fibrosis, Pulmonary
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Active, not recruiting
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
Cystic Fibrosis (CF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ralph Epaud principal investigator
CHI CRETEIL
Questions about this trial
What is this clinical trial studying?
A study testing walk tours in people with Cystic Fibrosis, Pulmonary, run by Centre Hospitalier Intercommunal Creteil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of exhaled breath condensate (EBC) for biomarker analysis (time frame: day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.