Clinical Trial

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

Study acronym: MUCOLIMEX
Recruiting
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Summary
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.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-04-23
notable Primary completion pushed: 2026-01-05 -> 2027-02-02 2026-04-23
minor Completion pushed: 2027-01-26 -> 2027-04-04 2026-04-23
Trial Details
NCT Number NCT07314229
Lead Sponsor University Hospital, Lille
Collaborators: Vaincre la Mucoviscidose
Conditions Cystic Fibrosis (CF), Mucoviscidosis
Enrollment 130 participants
Start Date 2025-12-17
Primary Completion 2027-02-02 (estimated)
Study Completion 2027-04-04 (estimated)
Updated on ClinicalTrials.gov 2026-04-22