NCT07394036

Effect of Ipratropium Bromide on EILO

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Cook Children's Health Care System · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Exercise-Induced Laryngeal Obstruction
• Dyspnea During Activity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-16
• Primary completion: 2029-03-30
• Completion: 2029-03-30
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study