Health TrialsbyHealthPanel

Prevalence of EILO Among Children With Asthma

ConditionsExercise Induced Laryngeal ObstructionAsthma in ChildrenExercise-Induced BronchospasmExercise-Induced BronchoconstrictionDyspneaLarynx
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorMedisch Spectrum Twente

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Prevalence of EILO

Prevalence of EILO (defined as Maat score grade 2 or higher) in study population, with 95% confidence interval

Time frame
During CLE test. Measured in period until 200 participants are enrolled, expected to be 2 years

Secondary outcomes

1

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.

Time frame
During CLE test which takes approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years
2

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.

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
3

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

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
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medisch Spectrum Twente

Lead sponsor

Haukeland University Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: