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Checks breathing limits during exercise in people with cystic fibrosis taking a modulator drug

Measures breathing during a walking test in adults with cystic fibrosis taking elexacaftor-tezacaftor-ivacaftor.

Plain-language title generated from the registry record
Registry title: Prevalence of Exercise-induced Ventilatory Limitation and Associated Factors in Patients With Cystic Fibrosis Receiving Elexacaftor-Tezacaftor-Ivacaftor

Key facts

Where
Lille, FranceSee the site

Where in France

  • University Hospital,Lille, FranceTaking people

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Trial details

Who runs it
University Hospital, Lille
Trial code
NCT07314229
Record updated
22 April 2026
Original description
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.Read full original descriptionShow less

Prevalence of Exercise-induced Ventilatory Limitation and Associated Factors in Patients With Cystic Fibrosis Receiving Elexacaftor-Tezacaftor-Ivacaftor

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.

Inclusion: 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.

Exclusion: Exacerbation of the condition in the 4 weeks preceding the V1 visit (27); Medical contraindication or inability to perform a stress test according to ERS recommendations; Absolute contraindications; Relative contraindications:; 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.

ClinicalTrials.gov NCT07314229