Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2024-08-01
2026-04-30
Brief Summary
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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
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
18 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Medisch Spectrum Twente
OTHER
Responsible Party
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Principal Investigators
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Vera Hengeveld, MD
Role: PRINCIPAL_INVESTIGATOR
Medisch Spectrum Twente
Locations
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Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
Countries
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Central Contacts
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Other Identifiers
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Prevalence EILO
Identifier Type: -
Identifier Source: org_study_id