Prevalence of EILO Among Children With Asthma (NCT06480084) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prevalence of EILO Among Children With Asthma
Netherlands200 participantsStarted 2024-08-01
Plain-language summary
The goal of this cross-sectional study is to investigate the prevalence of Exercise Induced Laryngeal Obstruction (EILO) in children with asthma.
The hypothesis is that the prevalence will be around 15%, which is higher than the prevalence of 5-8% among the general adolescent population. This is based on the increased prevalence of EILO among adult asthmatics.
Participants who are referred for an Exercise Challenge Test will perform an additional Continuous Laryngoscopy during Exercise Test with expiratory FEV1 curves, and fill in the Borg scale for dyspnea, Asthma Control Test, EILODI questionnaire and DISCO-RC questionnaire.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 12 to 18 years
* Paediatrician diagnosed asthma confirmed with at least one of the following during the last two years: Positive ECT (post-exercise fall in FEV1 \> 10%) / Positive methacholine test (PC20 value of ≤8 mg/mL) / Bronchodilator reversibility (increase in FEV1 ≥12% and/or ≥200 mL following inhalation of 200-400 μg short-acting β2-agonists)
Exclusion Criteria:
* Other severe cardiopulmonary disease
* Inability to perform ECT or CLE test
* Inability to perform technically acceptable spirometry
* Asthma exacerbation or respiratory tract infection in the last 2 weeks
* Short-acting β2-agonists or long-acting β2-agonists use less than respectively 8 and 24 hours before the ECT or CLE test
* Oral corticosteroid use in the 4 weeks before the ECT or CLE test
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of EILO
Timeframe: During CLE test. Measured in period until 200 participants are enrolled, expected to be 2 years