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NCT Number: NCT07394036

Effect of Ipratropium Bromide on EILO

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.

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cook Children's Pulmonology (Exercise Respiratory Center)

Prosper, Texas, 75078, United States

Location contact

Andreas Kreutzer, PhD

CONTACT

[email protected]

Andreas Kreutzer, PhD

SUB_INVESTIGATOR

John M Robertson, MD

CONTACT

[email protected]

682-303-4200

John M Robertson, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ipratropium bromide

Drug

Nebulized Ipratropium Bromide (500µg/2.5mL); one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes

Normal saline (placebo)

Drug

3 mL of nebulized 0.9% normal saline; one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes

Primary outcomes

  1. Visual Analogue Scale for Dyspnea (VAS-Dyspnea)

    Time frame: Day1 and Day 2

    Shortness of breath assessed by a 0-100 Visual Analogue Scale for Dyspnea, where higher scores reflect greater breathlessness

Secondary outcomes

  1. CLE grade scoring

    Time frame: Day 1 and Day 2

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Kreutzer, PhD

CONTACT

[email protected]

682-303-7576

John M Robertson, MD

CONTACT

[email protected]

682-303-4200

Sponsors and collaborators

Lead sponsor

Cook Children's Health Care System

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 6, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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