Clinical trial NCT06480084: Prevalence of EILO Among Children With Asthma
Official title: The Prevalence of Exercise-Induced Laryngeal Obstruction (EILO) Amongst Children With Asthma' - a Prospective Cross-sectional Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Exercise Induced Laryngeal Obstruction
Asthma in Children
Exercise-Induced Bronchospasm
Exercise-Induced Bronchoconstriction
Dyspnea
Larynx
Lead sponsor: Medisch Spectrum Twente
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2024-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cross-sectional study
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Background:Exertional dyspnoea is a common and limiting symptom within the paediatric population. Regular physical activity is paramount for the development of children since it not only promotes cardiorespiratory fitness and muscle strength, but also offers opportunities for self-expression, building confidence and social interaction and integration. It is therefore important to identify the correct cause(s) of exertional dyspnea and reverse them to enable children to be active without symptoms.

Exercise induced bronchoconstriction (EIB) is a well-known cause of exertional dyspnoea and is highly specific of childhood asthma. Another less recognized cause of exertional dyspnoea is exercise induced laryngeal obstruction (EILO). EILO is an inappropriate closure of the larynx during strenuous physical activity with no obvious laryngeal pathology at rest, limiting airflow and causing inspiratory stridor. It can co-exist with and mimic symptoms of EIB.

Previous studies showed a prevalence of 6% in adolescent populations). However, recent studies revealed a much higher prevalence ofEILO in adults with asthma, up to 25-47%. The prevalence of EILO amongst children with asthma has not yet been investigated. In this study, the aim is to investigate the prevalence of EILO in children with asthma.

If EILO is a significant comorbidity of childhood asthma this would implicate that EILO screening should be considered when exercise is a persistent trigger of symptoms in asthmatic children. Correct EILO diagnosis and treatment can lead to adequate treatment of EILO, and to prevention of overtreatment of asthma.

Methods: 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.

Power analysis: The sample size is calculated based on an estimated prevalence and confidence interval, with a power of 80% and alpha of 0.05. When estimating a prevalence of 15% (CI 10-20%), which is 2 times higher than in the general population (30), this results in a sample size of 196 participants. This was rounded to 200 participants. Dropouts will be replaced until a total number of 200 participants completed both the ECT and CLE test.

Statistical analysis for primary outcome: The prevalence of EILO in the study population of adolescents with asthma will be calculated as a percentage with a 95% confidence interval. Baseline characteristics will be compared between participants and non-participants of the CLE test. If there are no significant differences between these groups, it can be assumed that participants represent the studied population. If there are significant differences in baseline characteristics, we will examine the correlation of these characteristics with EILO. An estimated prevalence of EILO will be calculated among the non-participants based on these correlations, and an estimated weighted average will be calculated of the prevalence of EILO among the studied population.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of EILO
timeFrame: During CLE test. Measured in period until 200 participants are enrolled, expected to be 2 years
Secondary outcomes:
measure: Prevalence of EILO with and without current EIB
timeFrame: During CLE test which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of gender with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of age with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of length with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of weight with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of BMI Z score with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of hours of moderate-to-vigorous weekly activity with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of athletic performance (none/local/regional/national/international) with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of type of sports with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of medication use with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of comorbidities with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of recognizable symptoms with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of type of reported symptoms with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of heart rate during exercise with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of baseline FEV1 (% predicted) with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of maximal % post-exercise fall in FEV1 with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of maximal exercise intensity (wattage/kg or maximum running pace and slope) with presence of EILO
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of Asthma Control Test (ACT) with EILO
timeFrame: During CLE test which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of Exercise-Induced Laryngeal Obstruction Dyspnea Index (EILODI) with EILO
timeFrame: During CLE test which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of Visual Analogue Scale (VAS) with EILO
timeFrame: During CLE test which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Association of combination of questionnaire scores (Asthma Control Test (ACT), Exercise-Induced Laryngeal Obstruction Dyspnea Index (EILODI) and/or Visual Analogue Scale (VAS)) with EILO
timeFrame: During CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Assesment of EIB with CLE compared to ECT test
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Comparison of age between participants with similar and non-similar EIB results during CLE and ECT test
timeFrame: During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Comparison of test duration between participants with similar and non-similar EIB results during CLE and ECT test
timeFrame: During ECT and CLE test, which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Comparison of heart rate between participants with similar and non-similar EIB results during CLE and ECT test
timeFrame: During ECT and CLE test, which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Inter-rater agreement of EILO diagnosis between two participating hospitals
timeFrame: During CLE test, which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
measure: Self-reported discomfort of CLE test
timeFrame: After the CLE test, which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
Study officials:
affiliation: Medisch Spectrum Twente
name: Vera Hengeveld, MD
role: PRINCIPAL_INVESTIGATOR
References: