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Набор скоро начнётся NCT06134401

Nebulised Hypertonic Saline to Decrease Respiratory Exacerbations in Neuromuscular Disease or Neurodisability

Без фазы С лечением Neuromuscular Diseases Neurodevelopmental Disorders Cerebral Palsy

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: saline.
Кому может быть актуально
Состояния в реестре: Neuromuscular Diseases, Neurodevelopmental Disorders, Cerebral Palsy. Базовые параметры: от 5 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
Великобритания
Следующий шаг
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Официальное название

Effectiveness of Nebulised Hypertonic Saline to Decrease Respiratory Exacerbations in People With Neuromuscular Disease or Neurodisability: a Phase 2 Open Label Pilot Study

Обзор

Research Aim: This study investigates whether a 12-month treatment with hypertonic saline (salty water) can reduce antibiotic use in individuals with neuromuscular disease or cerebral palsy who frequently experience chest infections due to difficulty clearing mucus from their airways. Methodology: Participants will be randomly assigned to receive nebulised hypertonic saline (7% salt in water) or normal saline (0.9% salt in water). The study is open-label as both participants and researchers are aware of the treatment, necessary due to the differing tastes of the solutions. Two centers, Royal Brompton Hospital in London and Queens Medical Centre in Nottingham, will conduct the research. Before starting the treatment, participants will undergo various assessments, including questionnaires to measure quality of life and treatment satisfaction, sputum/throat swab collection, lung clearance index, forced oscillation technique, electrical impedance tomography, and lung ultrasound. Once these assessments are completed, participants will take the assigned treatment at home, administered twice daily for 12 months, with monthly follow-ups regarding difficulties and chest infections. After 12 months, the treatment will cease, and participants will repeat the assessments. Significance: This research will provide valuable insights into the efficacy of nebulised hypertonic saline for individuals with neuromuscular disease or cerebral palsy, potentially aiding both patients and doctors in making informed treatment decisions. Dissemination: The study's findings will be shared through publication in scientific journals and presentation at conferences.

Вмешательства

  • Устройство saline
    nebulised

Первичные конечные точки

  • Course of antibiotics for respiratory infections [Срок оценки: from baseline to week 52]
Вторичные конечные точки (12)
  • Lung clearance index [Срок оценки: at baseline before and within 2 hours after drug response assessment, and at week 52.]
  • Forced oscillation technique [Срок оценки: at baseline before and within 2 hours after drug response assessment, and at week 52.]
  • Forced oscillation technique [Срок оценки: at baseline before and within 2 hours after drug response assessment, and at week 52.]
  • Lung ultrasound [Срок оценки: at baseline before and within 2 hours after drug response assessment, and at week 52.]
  • Electrical Impedance Tomography [Срок оценки: at baseline before and within 2 hours after drug response assessment, and at week 52.]
  • Airway inflammation [Срок оценки: baseline and at week 52]
  • Airway inflammation [Срок оценки: baseline and at week 52]
  • Airway inflammation [Срок оценки: baseline and at week 52]
  • Airway inflammation [Срок оценки: baseline and at week 52]
  • Bacterial diversity [Срок оценки: baseline and at week 52]
  • Bacterial diversity [Срок оценки: baseline and at week 52]
  • Bacterial diversity [Срок оценки: baseline and at week 52]

Критерии участия

Критерии включения

  • Diagnosis of NMD or neurodisablity by a physician independent of the study, on standard criteria.
  • Age 5 years and above, including adults.
  • Must be able to tolerate nebulised 6% hypertonic saline.
  • Must have a history of at least one respiratory exacerbation requiring antibiotic treatment with or without the need for hospitalisation in the 12 months prior to recruitment.

Критерии исключения

  • Patients with additional diagnosis, for example, CF, but those with aspiration and/or bronchiectasis secondary to respiratory complications of NMD will be included.
  • Patients who are already prescribed daily HS in any concentration (i.e, 3%, 5%, 6%, 7%) will be excluded, but those who are on daily NS or have HS prescribed as part of their escalation plan (i.e., PRN) will be included.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Великобритания · 2 центра
  • Royal Brompton Hospital — London
  • Nottingham University Hospitals — Nottingham

Идентификаторы

NCT: NCT06134401 · 23IC8597

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗