Ipratropium Bromide for Exercise-Induced Laryngeal Obstruction

JM
AK
Overseen ByAndreas Kreutzer, PhD
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Cook Children's Health Care System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether ipratropium bromide can aid kids and teens with Exercise-Induced Laryngeal Obstruction (EILO) who experience breathing difficulties during exercise. Researchers aim to determine if this treatment reduces breathlessness and improves exercise capability compared to a placebo. The trial will test the treatment in two sequences: some participants will receive ipratropium bromide first, followed by a placebo, while others will receive the placebo first, followed by ipratropium bromide. Kids and teens diagnosed with EILO who frequently experience shortness of breath during exercise may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

If you are taking anticholinergic medications, you will need to pause them for 24 hours before participating in the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that ipratropium bromide is generally safe for use. The FDA has already approved it for other conditions, such as chronic obstructive pulmonary disease (COPD), indicating a strong safety record. In studies on exercise-induced laryngeal obstruction (EILO), participants experienced few serious side effects. Some mild effects, like dry mouth or a slight cough, were noted, which are common with inhaled medications and usually resolve quickly.

Overall, evidence suggests that ipratropium bromide is safe for conditions similar to EILO. However, as with any medication, individuals should monitor how it affects them personally.12345

Why do researchers think this study treatment might be promising for exercise-induced laryngeal obstruction?

Ipratropium Bromide is unique because it targets the underlying muscle contractions in the throat that cause exercise-induced laryngeal obstruction (EILO). Most current treatments for EILO focus on managing symptoms, such as using breathing techniques or medications that reduce inflammation. However, Ipratropium Bromide works by directly relaxing the airway muscles, potentially offering quicker and more direct relief. Researchers are excited about this treatment because it could provide a more efficient and targeted approach to easing the breathing difficulties associated with EILO, improving the quality of life for those affected by this condition.

What evidence suggests that ipratropium bromide might be an effective treatment for exercise-induced laryngeal obstruction?

Research suggests that ipratropium bromide, a medication that blocks certain signals in the throat, might help with symptoms of exercise-induced laryngeal obstruction (EILO). However, some studies have shown it did not improve breathing problems or exercise performance in people with EILO. Conversely, a report on a few cases showed symptom improvement when ipratropium bromide was used before exercise. This trial will compare the effects of ipratropium bromide with a placebo to determine its effectiveness for EILO. This mixed evidence indicates that while it might help some people, its overall effectiveness for EILO remains unclear. More research is needed to determine how well it works for this condition.24567

Are You a Good Fit for This Trial?

This trial is for children and adolescents who experience breathlessness and airway obstruction when they exercise, known as Exercise-Induced Laryngeal Obstruction (EILO). Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.

Inclusion Criteria

I, and if under age my parents too, agree to follow the study's procedures.
Patients must be able to complete exercise testing
My breathing issue during exercise was confirmed with a special throat camera test.
See 1 more

Exclusion Criteria

Patients who did not undergo diagnostic CPET with CLE
Patients with hypersensitivity to atropine or its derivatives due to structural similarity with ipratropium bromide
I have a history of atrial flutter or fibrillation.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ipratropium Bromide or Placebo during intense exercise sessions

2 days
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ipratropium Bromide

Trial Overview

The study is testing whether Ipratropium Bromide can reduce symptoms of EILO compared to a placebo. Participants will perform intense exercise after inhaling either the medication or saline solution to see if there's a difference in their breathlessness and airway obstruction.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Placebo, then Ipratropium BromideExperimental Treatment2 Interventions
Group II: Ipratropium Bromide, then PlaceboExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cook Children's Health Care System

Lead Sponsor

Trials
11
Recruited
5,001,000+

Citations

Use of inhaled ipratropium bromide to improve exercise ... - PMC

Inhaled IB did not improve CLE score, dyspnoea or exercise capacity in subjects with EILO. The study does not support the use of inhaled IB to treat EILO.

NCT07394036 | Effect of Ipratropium Bromide on EILO

It is hypothesized that breathlessness and airway obstruction will be lower following inhalation of ipratropium bromide compared with placebo.

Exercise induced laryngeal obstruction (EILO) in children ...

Ipratropium bromide, a muscarinic-receptor antagonist has been reported to improve EILO symptoms (glottic EILO) when used before exercise in a case series of ...

Effect of Ipratropium Bromide on EILO - ClinicalTrials.Veeva

It is hypothesized that breathlessness and airway obstruction will be lower following breathing in ipratropium bromide compared with placebo.

Use of inhaled ipratropium bromide to improve exercise ...

Inhaled IB did not improve CLE score, dyspnoea or exercise capacity in subjects with EILO. The study does not support the use of inhaled IB to treat EILO.

Atrovent in Exercise Induced Laryngeal Obstruction (EILO)

This study aims to address potential effects from Atrovent in patients with E-ILO verified during a continuous laryngoscopy exercise (CLE) test. The study will ...

Atrovent in Exercise Induced Laryngeal Obstruction (EILO)

Use of inhaled ipratropium bromide to improve exercise-induced laryngeal obstruction cannot be recommended · Exercise Induced Laryngeal Obstruction (EILO) while ...