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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-01-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis (CF) Mucoviscidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

No control group. Patients treated with ETI (Kaftrio-Kalydeco©) are treated as part of the management of their condition in accordance with the indications for marketing authorisation (MA), temporary authorisation for use (ATU) or French compassionate access.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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patients treated with ETI (Kaftrio-Kalydeco©)

Group Type EXPERIMENTAL

Measurement of resistance through forced oscillations and continuous measurement of ventilation and inspiratory capacity during TM6

Intervention Type DEVICE

Measurement of resistance through forced oscillations and continuous measurement of ventilation and inspiratory capacity during TM6

Interventions

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Measurement of resistance through forced oscillations and continuous measurement of ventilation and inspiratory capacity during TM6

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No