Exercise-Induced Laryngeal ObstructionPhase 2NCT07394036
Effect of Ipratropium Bromide on EILO
A Phase 2 study testing Ipratropium Bromide in people with Exercise-Induced Laryngeal Obstruction and Dyspnea During Activity, run by Cook Children's Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Exercise-Induced Laryngeal Obstruction, Dyspnea During Activity
- What is being tested?
- Ipratropium Bromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cook Children's Pulmonology (Exercise Respiratory Center)
Prosper, Texas, 75078
John M Robertson, MD, 682-303-4200, john.robertson@cookchildrens.org
Andreas Kreutzer, PhD, andy.kreutzer@cookchildrens.org
About this study
Official title: The Effect of Ipratropium Bromide on Exercise-Induced Laryngeal Obstruction (EILO) in Pediatric Patients
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.
Read the 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.
- Being tested
- Ipratropium Bromide, Normal Saline (Placebo)
- Keywords
- Exercise-Induced Laryngeal Obstruction, Shortness of Breath during Exercise, Ipratropium Bromide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipratropium BromideDrug
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 group | Role | What they receive |
|---|---|---|
| Ipratropium Bromide, then Placebo | Experimental | Participants will receive Ipratropium Bromide in their first trial and Placebo in the second trial. Receives: 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. Receives: Drug: Ipratropium Bromide; Drug: Normal Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day1 and Day 2
Secondary 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).
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-Induced Laryngeal ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook Children's Health Care System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394036
- Sponsor's protocol ID
- 2026-031
- Status last verified
- May 2026
- First submitted
- 12 Jan 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators anticipate the institution's IRB/legal team will not approve sharing IPD.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ipratropium Bromide on Exercise-Induced Laryngeal Obstruction (EILO) in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07394036
- Acronym / sponsor ID
- 2026-031
- Keywords
- Exercise-Induced Laryngeal Obstruction, Shortness of Breath during Exercise, Ipratropium Bromide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cook Children's Health Care SystemUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipratropium Bromide, then Placebo | Experimental | Drug: Ipratropium Bromide, Drug: Normal Saline (Placebo)Participants will receive Ipratropium Bromide in their first trial and Placebo in the second trial. |
| Placebo, then Ipratropium Bromide | Experimental | Drug: Ipratropium Bromide, Drug: Normal Saline (Placebo)Participants will receive Placebo in their first trial and Ipratropium Bromide in the second trial. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipratropium BromideNebulized Ipratropium Bromide (500µg/2.5mL); one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes | Drug | Ipratropium Bromide, then Placebo, Placebo, then Ipratropium Bromide |
| Normal Saline (Placebo)3 mL of nebulized 0.9% normal saline; one-time dose approximately 75 minutes before exercise, inhaled for 5-8 minutes | Drug | Ipratropium Bromide, then Placebo, Placebo, then Ipratropium Bromide |
Primary outcome
Visual Analogue Scale for Dyspnea (VAS-Dyspnea)
Time frame: Day1 and Day 2
Shortness of breath assessed by a 0-100 Visual Analogue Scale for Dyspnea, where higher scores reflect greater breathlessness
1 secondary outcome
CLE grade scoring
Time frame: Day 1 and Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No. The investigators anticipate the institution's IRB/legal team will not approve sharing IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipratropium Bromide in people with Exercise-Induced Laryngeal Obstruction and Dyspnea During Activity, run by Cook Children's Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John M Robertson, MD (682-303-4200, john.robertson@cookchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for Dyspnea (VAS-Dyspnea) (time frame: Day1 and Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.