Exercise Induced Laryngeal ObstructionNCT06480084
Prevalence of EILO Among Children With Asthma
A study testing Continuous Laryngoscopy during Exercise Test (CLE test) in people with Exercise Induced Laryngeal Obstruction and Asthma in Children, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Exercise Induced Laryngeal Obstruction, Asthma in Children, Exercise-Induced Bronchospasm
- What is being tested?
- Continuous Laryngoscopy during Exercise Test (CLE test)
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of Exercise-Induced Laryngeal Obstruction (EILO) Amongst Children With Asthma' - a Prospective Cross-sectional Study
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.
Read the 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.
- Conditions
- Exercise Induced Laryngeal Obstruction, Asthma in Children, Exercise-Induced Bronchospasm, Exercise-Induced Bronchoconstriction, Dyspnea, Larynx
- Being tested
- Continuous Laryngoscopy during Exercise Test (CLE test)
- Medical subject headings
- Asthma, Exercise-Induced, Dyspnea, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Laryngoscopy during Exercise Test (CLE test)Diagnostic test
A flexible fiberoptic laryngoscope (Olympus, Tokyo, Japan) is introduced directly through the nose or via a slightly modified Hans Rudolph facemask, and into the pharyngeal space. A modified Bruce protocol with a 60-second incremental intensity step is used (Appendix A) and heart rate is monitored. During the CLE test participants perform incremental exercise on a treadmill until symptom-limiting distress or exhaustion. Forced expiratory flow-volume loops are measured before, during and after the CLE test.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of EILO
Prevalence of EILO (defined as Maat score grade 2 or higher) in study population, with 95% confidence interval
Measured: During CLE test. Measured in period until 200 participants are enrolled, expected to be 2 years
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: After the CLE test, which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion30 Apr 2026 (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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cross-sectional study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Vera Hengeveld, MD, Principal investigator, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480084
- Sponsor's protocol ID
- Prevalence EILO
- Status last verified
- Jun 2024
- First submitted
- 12 Feb 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Exercise-Induced Laryngeal Obstruction (EILO) Amongst Children With Asthma' - a Prospective Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06480084
- Acronym / sponsor ID
- Prevalence EILO
- Conditions
- Exercise Induced Laryngeal Obstruction, Asthma in Children, Exercise-Induced Bronchospasm, Exercise-Induced Bronchoconstriction, Dyspnea, Larynx
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 28 Jun 2024 (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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- cross-sectional study
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Continuous Laryngoscopy during Exercise Test (CLE test)A flexible fiberoptic laryngoscope (Olympus, Tokyo, Japan) is introduced directly through the nose or via a slightly modified Hans Rudolph facemask, and into the pharyngeal space. A modified Bruce protocol with a 60-second incremental intensity step is used (Appendix A) and heart rate is monitored. During the CLE test participants perform incremental exercise on a treadmill until symptom-limiting distress or exhaustion. Forced expiratory flow-volume loops are measured before, during and after the CLE test. | Diagnostic test | – |
Primary outcome
Prevalence of EILO
Time frame: During CLE test. Measured in period until 200 participants are enrolled, expected to be 2 years
Prevalence of EILO (defined as Maat score grade 2 or higher) in study population, with 95% confidence interval
27 secondary outcomes
Prevalence of EILO with and without current EIB
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After the CLE test, which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Vera Hengeveld, MD principal investigator
Medisch Spectrum Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Laryngoscopy during Exercise Test (CLE test) in people with Exercise Induced Laryngeal Obstruction and Asthma in Children, run by Medisch Spectrum Twente at 1 site in Netherlands.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Jun 2024. 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 Netherlands. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vera Hengeveld, MD (+31 53 487 23 10, vera.hengeveld@mst.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of EILO (time frame: During CLE test. Measured in period until 200 participants are enrolled, expected to be 2 years). 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 28 Jun 2024.