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Набор скоро начнётся NCT07394036

Effect of Ipratropium Bromide on EILO

Фаза II С лечением Exercise-Induced Laryngeal Obstruction Dyspnea During Activity

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: Ipratropium Bromide, Normal Saline (Placebo).
Кому может быть актуально
Состояния в реестре: Exercise-Induced Laryngeal Obstruction, Dyspnea During Activity. Базовые параметры: 8 лет — 17 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
США
Следующий шаг
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Официальное название

The Effect of Ipratropium Bromide on Exercise-Induced Laryngeal Obstruction (EILO) in Pediatric Patients

Обзор

The investigators propose a study that compares breathlessness and airway obstruction during intense exercise in 34 children and adolescents with Exercise-Induced Laryngeal Obstruction after breathing in ipratropium bromide or placebo. It is hypothesized that breathlessness and airway obstruction will be lower following breathing in ipratropium bromide compared with placebo.

Подробное описание

Many children and adolescents struggle with breathing problems during exercise. These symptoms can lead them to underperform, quit sports, and in some cases, stop being active altogether. One under-recognized cause is Exercise-Induced Laryngeal Obstruction (EILO), a narrowing of the airway at the level of the voice box. Approximately 5-8% of adolescents and 20-40% of adolescent athletes have EILO, an estimated 4-6 million nationwide. The most common treatment for EILO is Speech Therapy, with or without Physical Therapy. Where available, this requires significant time and financial commitment from patients and their families to attend therapy sessions and complete at-home exercises.

Case reports as early as 1985 have suggested aerosolized ipratropium bromide as an effective EILO treatment. One larger study could not confirm this observation. However, this study used an outcome measure with low reliability and validity, did not use a placebo control, and administered a low dose of ipratropium bromide too close to exercise.

The investigators propose a study that compares breathlessness and airway obstruction during intense exercise in 34 children and adolescents with EILO following inhalation of a higher dose of nebulized ipratropium bromide with placebo. It is hypothesized that breathlessness and airway obstruction will be lower following inhalation of ipratropium bromide compared with placebo.

Вмешательства

  • Препарат Ipratropium Bromide
    Nebulized Ipratropium Bromide (500µg/2.5mL); one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes
  • Препарат Normal Saline (Placebo)
    3 mL of nebulized 0.9% normal saline; one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes

Первичные конечные точки

  • Visual Analogue Scale for Dyspnea (VAS-Dyspnea) [Срок оценки: Day1 and Day 2]
Вторичные конечные точки (1)
  • CLE grade scoring [Срок оценки: Day 1 and Day 2]

Критерии участия

Критерии включения

  • Patients must be diagnosed with EILO confirmed by Continuous Laryngoscopy During Exercise
  • Patients must be able to complete exercise testing
  • Patients must report dyspnea
  • Patients must have given assent with parental consent, understand all study procedures, and comply with them for the entire length of the study.

Критерии исключения

  • Patients that do not have EILO.
  • Patients who did not undergo diagnostic CPET with CLE.
  • Patients with hypersensitivity to atropine or its derivatives due to structural similarity with ipratropium bromide.
  • Patients with a history of atrial flutter and/or fibrillation
  • Patients taking anticholinergic medications that cannot be paused for 24 hours.
  • Unable to perform exercise tests
  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of patient or parent/legally authorized representative to give written informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Cook Children's Pulmonology (Exercise Respiratory Center) — Prosper

Идентификаторы

NCT: NCT07394036 · 2026-031

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗