Effect of Ipratropium Bromide on EILO

NCT07394036 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 2026-031
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise-Induced Laryngeal Obstruction; Dyspnea During Activity

Keywords

Exercise-Induced Laryngeal Obstruction; Shortness of Breath during Exercise; Ipratropium Bromide

Outcome Measures

Primary Outcomes (1)

• 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

  Day1 and Day 2

Secondary Outcomes (1)

• CLE grade scoring

  Day 1 and Day 2

Study Arms (2)

Ipratropium Bromide, then Placebo

EXPERIMENTAL

Participants will receive Ipratropium Bromide in their first trial and Placebo in the second trial.

Drug: Ipratropium Bromide; Drug: Normal Saline (Placebo)

Placebo, then Ipratropium Bromide

EXPERIMENTAL

Participants will receive Placebo in their first trial and Ipratropium Bromide in the second trial.

Drug: Ipratropium Bromide; Drug: Normal Saline (Placebo)

Interventions

Ipratropium Bromide DRUG

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

Ipratropium Bromide, then Placebo; Placebo, then Ipratropium Bromide

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

Ipratropium Bromide, then Placebo; Placebo, then Ipratropium Bromide

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cook Children's Health Care System: lead

Study Sites (1)

Cook Children's Pulmonology (Exercise Respiratory Center)

Prosper, Texas, 75078, United States

Location

MeSH Terms

Interventions

Ipratropium; Saline Solution

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

John M Robertson, MD

CONTACT

682-303-4200; john.robertson@cookchildrens.org

Andreas Kreutzer, PhD

CONTACT

682-303-7576; andy.kreutzer@cookchildrens.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 6, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)