Cystic Fibrosis Clinical Trial
— VOLATIL-CFOfficial title:
Volatilomic Approaches for the Study of CFTR Modulators
NCT number | NCT05726994 |
Other study ID # | APHP221173 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 6, 2023 |
Est. completion date | August 2024 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 2 Years and older |
Eligibility | Inclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Necker - Enfants malades | Paris | Ile-de-France |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | At 0 day, 7 days, and 1 month of treatment | |
Secondary | Weight | Weight measured at visits | At 0 day, 7 days, and 1 month of treatment | |
Secondary | Sweat test | Sweat test result | At 0 day, 7 days, and 1 month of treatment | |
Secondary | Induced sputum - microbiology | Results of microbiological analysis of induced sputum | At 0 day, 7 days, and 1 month of treatment | |
Secondary | Induced sputum - immunology | Results of inflammatory markers analysis of induced sputum (neutrophil elastase, IL-8, IL-1b, IL-6) | At 0 day, 7 days, and 1 month of treatment | |
Secondary | Spirometry | Results of spirometry FVC measurements | At 0 day, 7 days, and 1 month of treatment | |
Secondary | Spirometry | Results of spirometry FEV1 measurements | At 0 day, 7 days, and 1 month of treatment | |
Secondary | Spirometry | Results of spirometry DEM25-75 measurements | At 0 day, 7 days, and 1 month of treatment | |
Secondary | Urine | Biobanking for metabolic study | At 0 day and 1 month of treatment | |
Secondary | Blood | Biobanking for metabolic study | At 0 day and 1 month of treatment |
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