Effect of Ipratropium Bromide on EILO
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: Ipratropium Bromide, Normal Saline (Placebo).
- Who it may be relevant to
- Registry conditions: Exercise-Induced Laryngeal Obstruction, Dyspnea During Activity. Basic parameters: 8 years — 17 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
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Ipratropium Bromide on Exercise-Induced Laryngeal Obstruction (EILO) in Pediatric Patients
Overview
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.
Detailed description
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.
Interventions
- Drug Ipratropium Bromide
Nebulized Ipratropium Bromide (500µg/2.5mL); one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes - Drug Normal Saline (Placebo)
3 mL of nebulized 0.9% normal saline; one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes
Primary outcome measures
- Visual Analogue Scale for Dyspnea (VAS-Dyspnea) [Time frame: Day1 and Day 2]
Secondary outcome measures (1)
- CLE grade scoring [Time frame: Day 1 and Day 2]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cook Children's Pulmonology (Exercise Respiratory Center) — Prosper
Identifiers
NCT: NCT07394036 · 2026-031