Exercise-related breathing limits in adults with cystic fibrosis taking Elexacaftor‑Tezacaftor‑Ivacaftor
Prevalence of Exercise-induced Ventilatory Limitation and Associated Factors in Patients With Cystic Fibrosis Receiving Elexacaftor-Tezacaftor-Ivacaftor
NA · University Hospital, Lille · NCT07314229
We will test how often adults with cystic fibrosis who are taking Elexacaftor‑Tezacaftor‑Ivacaftor reach ventilatory limits during a six‑minute walk.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille (other) |
| Locations | 1 site (Lille) |
| Trial ID | NCT07314229 on ClinicalTrials.gov |
What this trial studies
This interventional protocol enrolls adults with cystic fibrosis on ETI at CF centers in Lille and Créteil to measure breathing responses during a standard six‑minute walk test. Participants will have continuous ventilation and inspiratory capacity measured during the test and airway resistance measured by forced oscillation. The main goal is to estimate the prevalence of ventilatory reserve loss (ventilatory limitation) during submaximal exercise in this treated population. Standard contraindications to exercise testing and recent exacerbations are used to exclude participants.
Who should consider this trial
Good fit: Adults (18+) with cystic fibrosis who are treated with ETI and followed at the CRCM centers in Lille or Créteil, able to perform a six‑minute walk and give informed consent are ideal candidates.
Not a fit: Children, people not on ETI, those unable to perform exercise testing (including recent exacerbation or contraindications), pregnant or breastfeeding women, and those not treated at the participating centers are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help clinicians identify patients who need targeted breathing or exercise rehabilitation to improve daily activity and quality of life.
How similar studies have performed: Prior studies show ETI improves lung function and symptoms, but few have specifically measured ventilatory limitation during submaximal exercise, so this question remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille
- University Hospital — Lille, France (RECRUITING)
Study contacts
- Study coordinator: Camille AUDOUSSET, Doctor
- Email: DRC@chu-lille.fr
- Phone: +33 3.20.44.41.45
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cystic Fibrosis, Mucoviscidosis, Cystic fibrosis, physical activity, CFTR modulator treatment, exercise limitation, respiratory physiology, ventilatory limitation