A Phase 2 interventional study of Ipratropium Bromide and Normal Saline (Placebo) in Exercise-Induced Laryngeal Obstruction and Dyspnea During Activity, sponsored by Cook Children's Health Care System. Not yet recruiting at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Cook Children's Health Care System · Phase 2, Interventional, and Treatment
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.
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.
Cook Children's Health Care System is the lead sponsor of 11 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive Ipratropium Bromide in their first trial and Placebo in the second trial.
Drug: Ipratropium Bromide · Drug: Normal Saline (Placebo)
Participants will receive Placebo in their first trial and Ipratropium Bromide in the second trial.
Drug: Ipratropium Bromide · Drug: Normal Saline (Placebo)
Nebulized Ipratropium Bromide (500µg/2.5mL); one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes
3 mL of nebulized 0.9% normal saline; one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes
Visual Analogue Scale for Dyspnea (VAS-Dyspnea)
Shortness of breath assessed by a 0-100 Visual Analogue Scale for Dyspnea, where higher scores reflect greater breathlessness
Time frame: Day1 and Day 2
CLE grade scoring
Patient videos will be assessed for laryngeal obstruction by two expert reviewers. Blinded reviewers will grade the severity of glottic and supraglottic obstruction on a scale from 0 (no obstruction) to 3 (severe obstruction).
Time frame: Day 1 and Day 2
Plan to share: No — The investigators anticipate the institution's IRB/legal team will not approve sharing IPD.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Cook Children's Health Care System