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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-06

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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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

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Cystic Fibrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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cystic fibrosis and Kaftrio®

20 children with cystic fibrosis aged 6 to 12 who initiate Kaftrio®

exhaled breath collection

Intervention Type BIOLOGICAL

Fasting children will be asked to breathe normally through a mouthpiece for the collection and analysis of exhaled breath.

Data collection

Intervention Type OTHER

Clinical data will be collected in order to seek correlations with the exhaled breath profile.

Interventions

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exhaled breath collection

Fasting children will be asked to breathe normally through a mouthpiece for the collection and analysis of exhaled breath.

Intervention Type BIOLOGICAL

Data collection

Clinical data will be collected in order to seek correlations with the exhaled breath profile.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with cystic fibrosis initiating Kaftrio® treatment.
* Patients and holders of parental authority not opposing participation in this research.