NCT07314229 Prevalence of Exercise-induced Ventilatory Limitation and Associated Factors in Patients With Cystic Fibrosis Receiving Elexacaftor-Tezacaftor-Ivacaftor
| NCT ID | NCT07314229 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Cystic Fibrosis (CF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2027-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2025-12-17 with a primary completion date of 2027-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07314229 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cystic Fibrosis (CF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07314229 currently recruiting?
Yes, NCT07314229 is actively recruiting participants. Contact the research team at DRC@chu-lille.fr for enrollment information.
Where is the NCT07314229 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT07314229 clinical trial?
NCT07314229 is sponsored by University Hospital, Lille. The trial plans to enroll 130 participants.