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Идёт набор NCT07314229

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

Без фазы С лечением Cystic Fibrosis (CF) Mucoviscidosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Measurement of resistance through forced oscillations and continuous measurement of ventilation and inspiratory capacity during TM6.
Кому может быть актуально
Состояния в реестре: Cystic Fibrosis (CF), Mucoviscidosis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство 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

Первичные конечные точки

  • 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. [Срок оценки: duration of 56 weeks starting in December 2025]
Вторичные конечные точки (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. [Срок оценки: 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 [Срок оценки: duration of 56 weeks starting in December 2025]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Франция · 1 центр
  • University Hospital — Lille

Идентификаторы

NCT: NCT07314229 · 2024_0277 · 2024-A02709-38

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗