Cystic FibrosisVOLATIL-CFNCT05726994
Volatilomic Approaches for the Study of CFTR Modulators (VOLATIL-CF)
An observational study of Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study relies on the hypotheses that (1) exhaled breath is intimately correlated to the patient's lung condition and that (2)the composition of exhaled breath , i.e. the VOCs profile, will be significantly modified from the first days of treatment by CFTR modulators in a or pauci/symptomatic patients such as young… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- exhaled breath collection and Data collection
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2023to 4 Jul 2024
- Phase
- Observational
- 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 2 years and older
- All sexes
- Child, Adult, Older adult
Study population: Children with cystic fibrosis aged 6 to 12 who will start Kaftrio® treatment.
Who may be able to join
- Patients with cystic fibrosis initiating Kaftrio® treatment.
- Patients and holders of parental authority not opposing participation in this research.
- Patients affiliated to a Health Insurance system or beneficiaries. Exclusion Criteria
- Patients deprived of liberty or under guardianship.
- Pregnant or breastfeeding patients.
- Lung transplanted patients.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Necker - Enfants malades
Paris, Île-de-France Region, 75015
About this study
Official title: Volatilomic Approaches for the Study of CFTR Modulators
This study relies on the hypotheses that (1) exhaled breath is intimately correlated to the patient's lung condition and that (2)the composition of exhaled breath , i.e. the VOCs profile, will be significantly modified from the first days of treatment by CFTR modulators in a or pauci/symptomatic patients such as young children under 12 years old. The non-invasive and longitudinal collection and analysis of exhaled breath may reveal modifications in signaling pathways impacted by these treatments on the very short term. This study is a single-center pilot study.
Read the detailed description
This is a single-center prospective cohort study that plans to include 20 children with cystic fibrosis aged 6 to 12 years old who will initiate Kaftrio® in early 2023.
The children will be monitored for one month; three visits are planned as part of routine care (before initiation of treatment, in the course of the first week and after one month of treatment) during which exhaled breath collection and analysis will also be performed. Access to clinical data collected throughout routine follow-up of these children (analysis of induced sputum, urine and blood, sweat test, respiratory function tests) will be granted upon patient/parent authorization.
- Conditions
- Cystic Fibrosis
- Being tested
- exhaled breath collection, Data collection
- Keywords
- Cystic Fibrosis, volatile organic compounds (VOC), exhaled breath, CFTR modulators
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exhaled breath collectionBiological
Fasting children will be asked to breathe normally through a mouthpiece for the collection and analysis of exhaled breath.
Data collectionOther
Clinical data will be collected in order to seek correlations with the exhaled breath profile.
| Study group | Role | What they receive |
|---|---|---|
| cystic fibrosis and Kaftrio® | 20 children with cystic fibrosis aged 6 to 12 who initiate Kaftrio® Receives: Biological: exhaled breath collection; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
volatile organic compounds (VOC) profile
identification of VOCs in exhaled breath with a significant variation between 0 day, 7 days, and/or 1 month of treatment
Measured: At 0 day, 7 days, and 1 month of treatment
Secondary outcomes (9)
Weight
Weight measured at visits
Measured: At 0 day, 7 days, and 1 month of treatment
Sweat test
Sweat test result
Measured: At 0 day, 7 days, and 1 month of treatment
Induced sputum - microbiology
Results of microbiological analysis of induced sputum
Measured: At 0 day, 7 days, and 1 month of treatment
Induced sputum - immunology
Results of inflammatory markers analysis of induced sputum (neutrophil elastase, IL-8, IL-1b, IL-6)
Measured: At 0 day, 7 days, and 1 month of treatment
Spirometry
Results of spirometry FVC measurements
Measured: At 0 day, 7 days, and 1 month of treatment
Spirometry
Results of spirometry FEV1 measurements
Measured: At 0 day, 7 days, and 1 month of treatment
Spirometry
Results of spirometry DEM25-75 measurements
Measured: At 0 day, 7 days, and 1 month of treatment
Urine
Biobanking for metabolic study
Measured: At 0 day and 1 month of treatment
Blood
Biobanking for metabolic study
Measured: At 0 day and 1 month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start6 Feb 2023
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Isabelle SERMET-GAUDELUS, Professor, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726994
- Sponsor's protocol ID
- APHP221173
- Acronym
- VOLATIL-CF
- Status last verified
- Jun 2026
- First submitted
- 12 Jan 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volatilomic Approaches for the Study of CFTR Modulators
- ClinicalTrials.gov ID
- NCT05726994
- Acronym / sponsor ID
- VOLATIL-CF / APHP221173
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, volatile organic compounds (VOC), exhaled breath, CFTR modulators
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 14 Feb 2023 (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.
This study relies on the hypotheses that (1) exhaled breath is intimately correlated to the patient's lung condition and that (2)the composition of exhaled breath , i.e. the VOCs profile, will be significantly modified from the first days of treatment by CFTR modulators in a or pauci/symptomatic patients such as young children under 12 years old. The non-invasive and longitudinal collection and analysis of exhaled breath may reveal modifications in signaling pathways impacted by these treatments on the very short term. This study is a single-center pilot study.
Detailed description
This is a single-center prospective cohort study that plans to include 20 children with cystic fibrosis aged 6 to 12 years old who will initiate Kaftrio® in early 2023.
The children will be monitored for one month; three visits are planned as part of routine care (before initiation of treatment, in the course of the first week and after one month of treatment) during which exhaled breath collection and analysis will also be performed. Access to clinical data collected throughout routine follow-up of these children (analysis of induced sputum, urine and blood, sweat test, respiratory function tests) will be granted upon patient/parent authorization.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cystic fibrosis and Kaftrio® | – | Biological: exhaled breath collection, Other: Data collection20 children with cystic fibrosis aged 6 to 12 who initiate Kaftrio® |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Children with cystic fibrosis aged 6 to 12 who will start Kaftrio® treatment.
Key inclusion criteria (6 listed)
- Patients with cystic fibrosis initiating Kaftrio® treatment.
- Patients and holders of parental authority not opposing participation in this research.
- Patients affiliated to a Health Insurance system or beneficiaries. Exclusion Criteria
- Patients deprived of liberty or under guardianship.
- Pregnant or breastfeeding patients.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| exhaled breath collectionFasting children will be asked to breathe normally through a mouthpiece for the collection and analysis of exhaled breath. | Biological | cystic fibrosis and Kaftrio® |
| Data collectionClinical data will be collected in order to seek correlations with the exhaled breath profile. | Other | cystic fibrosis and Kaftrio® |
Primary outcome
volatile organic compounds (VOC) profile
Time frame: At 0 day, 7 days, and 1 month of treatment
identification of VOCs in exhaled breath with a significant variation between 0 day, 7 days, and/or 1 month of treatment
9 secondary outcomes
Weight
Time frame: At 0 day, 7 days, and 1 month of treatment
Sweat test
Time frame: At 0 day, 7 days, and 1 month of treatment
Induced sputum - microbiology
Time frame: At 0 day, 7 days, and 1 month of treatment
Induced sputum - immunology
Time frame: At 0 day, 7 days, and 1 month of treatment
Spirometry
Time frame: At 0 day, 7 days, and 1 month of treatment
Spirometry
Time frame: At 0 day, 7 days, and 1 month of treatment
Spirometry
Time frame: At 0 day, 7 days, and 1 month of treatment
Urine
Time frame: At 0 day and 1 month of treatment
Blood
Time frame: At 0 day and 1 month of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Isabelle SERMET-GAUDELUS, Professor study director
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 0 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: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
volatile organic compounds (VOC) profile (time frame: At 0 day, 7 days, and 1 month of treatment). 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 1 Jul 2026.