Treatment With Elexacaftor/Tezacaftor/Ivacaftor, in Patients With Cystic Fibrosis and Caloric Intake

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: nutritional intake questionnaire

• Registration Number: NCT06072365
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

The aim of the study is to describe the evolution of caloric intake in patients with cystic fibrosis with an indication to start treatment with Elexacaftor/Tezacaftor/Ivacaftor according to the Marketing Authorization, between the start of treatment and at 12 months.

Detailed Description

Cystic fibrosis is a genetic pathology linked to a dysfunction of the CFTR protein.

Undernutrition is common in the natural course of cystic fibrosis, it is linked to exocrine pancreatic insufficiency but also to the increase in energy expenditure due to respiratory damage.

At a time when these CFTR modulators are greatly modifying the prognosis and management of cystic fibrosis, it is important to describe how caloric and nutritional intake evolve under treatment with Elexacaftor/Tezacaftor/Ivacaftor in order to be able, in the long term, to adapt nutritional recommendations under treatment with CFTR modulators.

The aim of the study is to describe the evolution of caloric intake in patients with cystic fibrosis with an indication to start treatment with Elexacaftor/Tezacaftor/Ivacaftor according to the Marketing Authorization, between the start of treatment and at 12 months.

Study Timeline

• Study Start: 2021-10-21
• Primary Completion: 2022-09-23
• Study Completion: 2023-01-15
• Status Verified: 2023-10
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Last Update Submitted: 2023-10-02
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patient with cystic fibrosis
• Patient with an indication to start treatment with Elexacaftor/Tezacaftor/Ivacaftor according to the Marketing Authorization.
• Patient who has not received treatment with CFTR modulators in the 6 months preceding inclusion.
• No opposition expressed by the patient (if ≥ 18 years) or by at least one of the holders of parental authority and the child (if < 18 years).
• Be affiliated to a social security scheme or be a beneficiary of such a scheme.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cystic fibrosis	nutritional intake questionnaire	patient with cystic fibrosis treated with With Elexacaftor/Tezacaftor/Ivacaftor,

Primary Outcome Measures

Name	Time	Method
caloric intake 12 months after the beginning of treatment	12 months	Describe the evolution of caloric intake in patients with cystic fibrosis with an indication to start treatment with Elexacaftor/Tezacaftor/Ivacaftor according to the Marketing Authorization, between the start of treatment and at 12 months.

Secondary Outcome Measures

Name	Time	Method
caloric intake 3 months after the beginning of treatment	3 months	Describe the evolution of caloric intake in patients with cystic fibrosis with an indication to start treatment with Elexacaftor/Tezacaftor/Ivacaftor according to the Marketing Authorization, between the start of treatment and at 3 months.

Trial Locations

Locations (3)

UHBordeaux; 🇫🇷 Bordeaux, France

UHLimoges; 🇫🇷 Limoges, France

UHToulouse; 🇫🇷 Toulouse, France