NCT05726994

Volatilomic Approaches for the Study of CFTR Modulators (VOLATIL-CF)

Volatilomic Approaches for the Study of CFTR Modulators

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: —

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 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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
BIOLOGICAL	exhaled breath collection	Fasting children will be asked to breathe normally through a mouthpiece for the collection and analysis of exhaled breath.
OTHER	Data collection	Clinical data will be collected in order to seek correlations with the exhaled breath profile.

Timeline

• Start date: 2023-02-06
• Primary completion: 2024-02-01
• Completion: 2024-08-01
• First posted: 2023-02-14
• Last updated: 2023-03-22

Locations

1 site across 1 country: France