Status:
UNKNOWN
Evolution of the 6-minute Walk Test in Patients Treated With ELEXACAFTOR / TEZACAFTOR / IVACAFTOR
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Brief Summary
The aim of the study is to identify a link between the new CFTR modulators and physical activity in cystic fibrosis patients. The triple combination of CFTR modulators (ELEXACAFTOR / TEZACAFTOR/ IVAC...
Eligibility Criteria
Inclusion
- Patients aged ≥ 12 years with cystic fibrosis, heterozygous for the F508del mutation of the CFTR gene, treated with ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR.
- Patients followed in the respiratory diseases department of the Renee Sabran Hospital
- 6-minute walked test performed in the year preceding initiation of ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR
- 6-minute walked test performed after treatment initiation (between the 3rd month and the 14th month)
- No opposition to participation
Exclusion
- \- Age \< 12 years
- Pregnancy
- Discontinuation or reduction in dosage of ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR
- Patients objecting to the use of their data for research purposes
Key Trial Info
Start Date :
August 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT06184763
Start Date
August 1 2023
End Date
November 1 2024
Last Update
December 28 2023
Active Locations (1)
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1
Respiratory diseases department, Renee Sabran Hospital (Hospices civils de Lyon)
Giens, France, 83406