Prevalence of EILO Among Children With Asthma
NCT Number: NCT06480084
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Exercise Induced Laryngeal Obstruction|Asthma in Children|Exercise-Induced Bronchospasm|Exercise-Induced Bronchoconstriction|Dyspnea|Larynx
Interventions: DIAGNOSTIC_TEST: Continuous Laryngoscopy during Exercise Test (CLE test)
Sponsor: Medisch Spectrum Twente
Collaborators: Haukeland University Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-01
Completion Date: 2026-04-30
Locations: Medisch Spectrum Twente, Enschede, Overijssel, 7512 KZ, Netherlands

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.

Primary Outcome Measures: Prevalence of EILO, Prevalence of EILO (defined as Maat score grade 2 or higher) in study population, with 95% confidence interval, During CLE test. Measured in period until 200 participants are enrolled, expected to be 2 years
Secondary Outcome Measures: Prevalence of EILO with and without current EIB, The prevalence of EILO among adolescents with and without current EIB will be calculated using a 2x2 table, including 95% confidence intervals. These prevalences will be compared with a Chi-Square test or Fisher's exact test., During CLE test which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of gender with presence of EILO, Baseline characteristics of adolescents with and without EILO will be compared. Association of gender with presence of EILO will be compared using a Chi-square or Fisher's exact test for categorical variables., During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of age with presence of EILO, Baseline characteristics of adolescents with and without EILO will be compared. Association of age with presence of EILO will be compared using a T-test (or non-parametric Mann Whitney U test) for continuous variables, During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of length with presence of EILO, Baseline characteristics of adolescents with and without EILO will be compared. Association of length with presence of EILO will be compared using a T-test (or non-parametric Mann Whitney U test) for continuous variables, During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of weight with presence of EILO, Baseline characteristics of adolescents with and without EILO will be compared. Association of weight with presence of EILO will be compared using a T-test (or non-parametric Mann Whitney U test) for continuous variables, During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of BMI Z score with presence of EILO, Baseline characteristics of adolescents with and without EILO will be compared. Association of BMI Z score with presence of EILO will be compared using a T-test (or non-parametric Mann Whitney U test) for continuous variables, During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of hours of moderate-to-vigorous weekly activity with presence of EILO, Baseline characteristics of adolescents with and without EILO will be compared. Association of hours of moderate-to-vigorous weekly activity with presence of EILO will be compared using a T-test (or non-parametric Mann Whitney U test) for continuous variables, During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of athletic performance (none/local/regional/national/international) with presence of EILO, Baseline characteristics of adolescents with and without EILO will be compared. Association of athletic performance (none/local/regional/national/international) with presence of EILO will be compared using a Chi-square or Fisher's exact test for categorical variables., During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of type of sports with presence of EILO, Baseline characteristics of adolescents with and without EILO will be compared. Association of type of sports with presence of EILO will be compared using a Chi-square or Fisher's exact test for categorical variables., During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of medication use with presence of EILO, Baseline characteristics of adolescents with and without EILO will be compared. Association of medication use with presence of EILO will be compared using a Chi-square or Fisher's exact test for categorical variables., During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of comorbidities with presence of EILO, Baseline characteristics of adolescents with and without EILO will be compared. Association of comorbidities with presence of EILO will be compared using a Chi-square or Fisher's exact test for categorical variables., During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of recognizable symptoms with presence of EILO, Test characteristics of adolescents with and without EILO will be compared. Association of of recognizable symptoms with presence of EILO will be compared using a Chi-square or Fisher's exact test for categorical variables., During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of type of reported symptoms with presence of EILO, Test characteristics of adolescents with and without EILO will be compared. Association of of type of reported symptoms with presence of EILO will be compared using a Chi-square or Fisher's exact test for categorical variables., During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of heart rate during exercise with presence of EILO, Test characteristics of adolescents with and without EILO will be compared. Association of of heart rate during the exercise test with presence of EILO will be compared using a T-test (or non-parametric Mann Whitney U test), During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of baseline FEV1 (% predicted) with presence of EILO, Test characteristics of adolescents with and without EILO will be compared. Association of of baseline FEV1 (% predicted) with presence of EILO will be compared using a T-test (or non-parametric Mann Whitney U test), During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of maximal % post-exercise fall in FEV1 with presence of EILO, Test characteristics of adolescents with and without EILO will be compared. Association of of maximal % post-exercise fall in FEV1 with presence of EILO will be compared using a T-test (or non-parametric Mann Whitney U test), During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of maximal exercise intensity (wattage/kg or maximum running pace and slope) with presence of EILO, Test characteristics of adolescents with and without EILO will be compared. Exercise intensity will be measured by wattage/kg or maximum running pace and slope and categorized into poor / average / good. Association of of exercise intensity with presence of EILO will be compared using a Chi-square or Fisher's exact test for categorical variables, During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of Asthma Control Test (ACT) with EILO, The ACT score and sub scores will be compared between adolescents with and without EILO using a T-test (or non-parametric Mann-Whitney U test). A receiver operating characteristic curve and 2x2 tables will be used to evaluate the sensitivity and specificity of different cut-off points of these questionnaires., During CLE test which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of Exercise-Induced Laryngeal Obstruction Dyspnea Index (EILODI) with EILO, EILODI score and sub scores will be compared between adolescents with and without EILO using a T-test (or non-parametric Mann-Whitney U test). A receiver operating characteristic curve and 2x2 tables will be used to evaluate the sensitivity and specificity of different cut-off points of these questionnaires., During CLE test which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Association of Visual Analogue Scale (VAS) with EILO, VAS scores will be compared between adolescents with and without EILO using a T-test (or non-parametric Mann-Whitney U test). A receiver operating characteristic curve and 2x2 tables will be used to evaluate the sensitivity and specificity of different cut-off points of these questionnaires., During CLE test which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|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, Questionnaire scores (ACT, EILODI, and/or VAS) and sub scores will be compared between adolescents with and without EILO using a T-test (or non-parametric Mann-Whitney U test). A receiver operating characteristic curve and 2x2 tables will be used to evaluate the sensitivity and specificity of different cut-off points of these questionnaires., During CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Assesment of EIB with CLE compared to ECT test, Lung function measurements during the CLE test will be compared to lung function measurements during the ECT using a Bland-Altman plot. A 2x2 table will be made of EIB presence during the ECT and CLE test and outcomes will be compared using a Chi-Square test., During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Comparison of age between participants with similar and non-similar EIB results during CLE and ECT test, Age will be compared between participants with similar and non-similar results during the ECT and CLE test using a T-test, or a non-parametric Mann-Whitney U test, During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Comparison of test duration between participants with similar and non-similar EIB results during CLE and ECT test, Test duration will be compared between participants with similar and non-similar results during the ECT and CLE test using a T-test, or a non-parametric Mann-Whitney U test, During ECT and CLE test, which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Comparison of heart rate between participants with similar and non-similar EIB results during CLE and ECT test, Heart rate will be compared between participants with similar and non-similar results during the ECT and CLE test using a T-test, or a non-parametric Mann-Whitney U test, During ECT and CLE test, which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Inter-rater agreement of EILO diagnosis between two participating hospitals, Inter-rater agreement of the presence of EILO and the Maat score of laryngoscopical images of the larynx, between both hospitals will be described using Cohen's weighted x., During CLE test, which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years|Self-reported discomfort of CLE test, The self-reported discomfort during the CLE test will be calculated based on the DISCO-RC questionnaire scores., After the CLE test, which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years