An observational study in Cystic Fibrosis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 50 is below the median of 85 across 482 observational studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children with cystic fibrosis aged 6 to 12 who will start Kaftrio® treatment.
Inclusion Criteria:
20 children with cystic fibrosis aged 6 to 12 who initiate Kaftrio®
Biological: exhaled breath collection · Other: Data collection
Fasting children will be asked to breathe normally through a mouthpiece for the collection and analysis of exhaled breath.
Clinical data will be collected in order to seek correlations with the exhaled breath profile.
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
Time frame: At 0 day, 7 days, and 1 month of treatment
Weight
Weight measured at visits
Time frame: At 0 day, 7 days, and 1 month of treatment
Sweat test
Sweat test result
Time frame: At 0 day, 7 days, and 1 month of treatment
Induced sputum - microbiology
Results of microbiological analysis of induced sputum
Time frame: 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)
Time frame: At 0 day, 7 days, and 1 month of treatment
Spirometry
Results of spirometry FVC measurements
Time frame: At 0 day, 7 days, and 1 month of treatment
Spirometry
Results of spirometry FEV1 measurements
Time frame: At 0 day, 7 days, and 1 month of treatment
Spirometry
Results of spirometry DEM25-75 measurements
Time frame: At 0 day, 7 days, and 1 month of treatment
Urine
Biobanking for metabolic study
Time frame: At 0 day and 1 month of treatment
Blood
Biobanking for metabolic study
Time frame: At 0 day and 1 month of treatment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris