Prevalence of Exercise-induced Ventilatory Limitation and Associated Factors in Patients With Cystic Fibrosis Receiving Elexacaftor-Tezacaftor-Ivacaftor
Recruiting now · Not applicable
Conditions studied: Cystic Fibrosis (CF), Mucoviscidosis
In brief
Cystic fibrosis is a genetic disorder affecting the entire body and associated with respiratory exacerbations, impaired quality of life and reduced life expectancy. The therapeutic management of cystic fibrosis has been profoundly changed by the recent arrival of a combination of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators, Elexacaftor-Tezacaftor-Ivacaftor (ETI), which improve quality of life, respiratory function and reducing the number of exacerbations. The impact of these treatments on exercise adaptation has not been clearly identified. The main objective is to estimate the prevalence of ventilatory reserve amputation during submaximal exercise testing assessed by the 6-minute walk test (6MWT) in patients with cystic fibrosis treated with ETIs.
Key facts
- Study ID
- NCT07314229
- Run by
- University Hospital, Lille
- People needed
- 130
- Starts
- 2025-12-17
- Expected to finish
- 2027-04-04
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female
- Adult aged 18 or over
- Suffering from cystic fibrosis
- Treated at the CRCM in Lille and Créteil
- Treated by ETI
- Be covered by social security
- Be able to understand the requirements of the study, provide written informed consent, and comply with the study's data collection procedures
You may not qualify if…
- Medical contraindication or inability to perform a stress test according to ERS recommendations
- Absolute contraindications
- Relative contraindications:
- Exacerbation of the condition in the 4 weeks preceding the V1 visit (27).
- Pregnant or breastfeeding women
- Administrative reasons
- Persons deprived of their liberty
- Minors or protected adults
- Persons who have refused or are unable to give informed consent
- Persons in emergency situations
Where it is running
- University Hospital — Lille, France (enrolling)
Full record on ClinicalTrials.gov
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