Prevalence of EILO Among Children With Asthma

NCT06480084 | Not Yet Recruiting

• 1 other identifier: Prevalence EILO
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Induced Laryngeal Obstruction; Asthma in Children; Exercise-Induced Bronchospasm; Exercise-Induced Bronchoconstriction; Dyspnea; Larynx

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (27)

• Prevalence of EILO with and without current EIB

  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

  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

  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

  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

  During ECT and CLE test which each take approximately one hour. Measured in period until 200 participants are enrolled, expected to be 2 years

Interventions

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.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medisch Spectrum Twente: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

Medisch Spectrum Twente

Enschede, Overijssel, 7512 KZ, Netherlands

Location

MeSH Terms

Conditions

Asthma, Exercise-Induced; Dyspnea; Laryngeal Diseases

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Otorhinolaryngologic Diseases

Study Officials

• Vera Hengeveld, MD

  Medisch Spectrum Twente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vera Hengeveld, MD

CONTACT

+31 53 487 23 10; vera.hengeveld@mst.nl

Mattienne van der Kamp, PhD

CONTACT

+31 53 487 23 10; m.vanderkamp@mst.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cross-sectional study

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: June 28, 2024
• Study Start: August 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 30, 2026
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)