Effect of Ipratropium Bromide on EILO

Part of paid clinical trials in Prosper, Texas.

Sponsor
Cook Children's Health Care System
Study ID
NCT07394036
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Dyspnea During Activity
  • Exercise-Induced Laryngeal Obstruction

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Ipratropium Bromide, then Placebo
    Participants will receive Ipratropium Bromide in their first trial and Placebo in the second trial.
  • Experimental: Placebo, then Ipratropium Bromide
    Participants will receive Placebo in their first trial and Ipratropium Bromide in the second trial.

Primary Outcome Measure

Visual Analogue Scale for Dyspnea (VAS-Dyspnea) [ Time Frame: Day1 and Day 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cook Children's Pulmonology (Exercise Respiratory Center)ProsperTexas75078
John M Robertson, MD
[email protected]
682-303-4200
Andreas Kreutzer, PhD
[email protected]
John M Robertson, MD (PRINCIPAL_INVESTIGATOR)
Andreas Kreutzer, PhD (SUB_INVESTIGATOR)

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Cook Children's Pulmonology (Exercise Respiratory Center)· Prosper, TX