Prevalence of Exercise-induced Ventilatory Limitation and Associated Factors in Patients With Cystic Fibrosis Receiving Elexacaftor-Tezacaftor-Ivacaftor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Measurement of resistance through forced oscillations and continuous measurement of ventilation and inspiratory capacity during TM6.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis (CF), Mucoviscidosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
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.
Interventions
- Device Measurement of resistance through forced oscillations and continuous measurement of ventilation and inspiratory capacity during TM6
Measurement of resistance through forced oscillations and continuous measurement of ventilation and inspiratory capacity during TM6
Primary outcome measures
- Estimate the prevalence of ventilatory limitation measured by a portable spirometer during a submaximal exercise test (6-minute walk test) in patients with cystic fibrosis undergoing ETI. [Time frame: duration of 56 weeks starting in December 2025]
Secondary outcome measures (2)
- Estimate the prevalence of ventilatory limitation measured using a portable spirometer during a maximal incremental step test (A-STEP) with progressive steps in patients with cystic fibrosis undergoing ETI. [Time frame: duration of 56 weeks starting in December 2025]
- Assessment of the prevalence of dynamic distension during a submaximal (TM6) or maximal (incremental step test according to the A-Step protocol) exercise test by spirometry [Time frame: duration of 56 weeks starting in December 2025]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 1 center
- University Hospital — Lille
Identifiers
NCT: NCT07314229 · 2024_0277 · 2024-A02709-38