Effect of Ipratropium Bromide on EILO
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-17
SponsorCook Children's Health Care System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Ipratropium Bromide
DrugNebulized Ipratropium Bromide (500µg/2.5mL); one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes
Normal Saline (Placebo)
Drug3 mL of nebulized 0.9% normal saline; one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Ipratropium Bromide, then PlaceboExperimental treatment 2 interventions
Group B: Placebo, then Ipratropium BromideExperimental treatment 2 interventions
Trial outcomes
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
Time frame
Day1 and Day 2Secondary outcomes
1
CLE grade scoring
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).
Time frame
Day 1 and Day 2Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: