Dyspnea During Activity, Exercise-Induced Laryngeal Obstruction
Conditions
Keywords
Exercise-Induced Laryngeal Obstruction, Shortness of Breath during Exercise, Ipratropium Bromide
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.
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.
Interventions
DRUGIpratropium Bromide
Nebulized Ipratropium Bromide (500µg/2.5mL); one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes
DRUGNormal Saline (Placebo)
3 mL of nebulized 0.9% normal saline; one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes
Sponsors
Cook Children's Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale for Dyspnea (VAS-Dyspnea) | Day1 and Day 2 | Shortness of breath assessed by a 0-100 Visual Analogue Scale for Dyspnea, where higher scores reflect greater breathlessness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CLE grade scoring | 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). |
Countries
United States
Contacts
CONTACTJohn M Robertson, MD
CONTACTAndreas Kreutzer, PhD
Outcome results
None listed