Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date March 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Charlotte ROY, Doctor
Phone +33 1 44 49 44 92
Email charlotte.roy@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Hôpital Necker - Enfants malades Paris Ile-de-France

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT04696198 - Thoracic Mobility in Cystic Fibrosis Care N/A
Completed NCT00803205 - Study of Ataluren (PTC124™) in Cystic Fibrosis Phase 3
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03601637 - Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del Phase 3
Terminated NCT02769637 - Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
Recruiting NCT06012084 - The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis N/A
Recruiting NCT06030206 - Lung Transplant READY CF 2: A Multi-site RCT N/A
Recruiting NCT06032273 - Lung Transplant READY CF 2: CARING CF Ancillary RCT N/A
Recruiting NCT06088485 - The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
Recruiting NCT05392855 - Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF) N/A
Recruiting NCT04039087 - Sildenafil Exercise: Role of PDE5 Inhibition Phase 2/Phase 3
Recruiting NCT04056702 - Impact of Triple Combination CFTR Therapy on Sinus Disease.
Completed NCT04038710 - Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
Completed NCT04058548 - Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation N/A
Completed NCT03637504 - Feasibility of a Mobile Medication Plan Application in CF Patient Care N/A
Recruiting NCT03506061 - Trikafta in Cystic Fibrosis Patients Phase 2
Completed NCT03566550 - Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
Recruiting NCT04828382 - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Completed NCT04568980 - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Recruiting NCT04010253 - Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis N/A