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Diagnosis of EIB in Young Elite Athletes (13-18 y)

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ClinicalTrials.gov Identifier: NCT03587675
Recruitment Status : Active, not recruiting
First Posted : July 16, 2018
Last Update Posted : November 5, 2021
Information provided by (Responsible Party):
Universitaire Ziekenhuizen KU Leuven

Brief Summary:
The investigators recently observed airway inflammation and increased damage-associated molecular pattern (DAMP) level in sputum of children (age 11-12y) and adolescents (18-23y) from elite sport programs in Belgium with increased risk of bronchoconstriction upon extreme exercise. They here want to validate these findings in a cohort 13-18y.

Condition or disease Intervention/treatment Phase
Exercise Induced Bronchospasm Athletes Adolescent Diagnostic Test: EVH test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: adolescents from different athletic disciplines and recreational adolescents will be tested for atopy, exercise-induced bronchospasm measured by EVH and biomarkers for EIB will be studied in blood and induced sputum
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation Screening Protocol for the Diagnosis of Exercise-induced Bronchoconstriction in Young Elite Athletes (13-18 y)
Actual Study Start Date : January 2017
Actual Primary Completion Date : November 2021
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
EVH in high-school elite athletes
EVH-test, skin prick test, sputum induction in all subjects Interventional but no drug or device tested
Diagnostic Test: EVH test
Other Names:
  • sputum induction
  • skin prick test
  • peripheral blood test
  • nasal lavage

Primary Outcome Measures :
  1. incidence of athletes with exercise-induced bronchospasm [ Time Frame: 2 years ]
    measured by positive EVH test: at least 10% drop in FEV1% between 5-20' after EVH

Secondary Outcome Measures :
  1. use of questionnaire to predict positive EVH test [ Time Frame: 2 years ]
    AQUA questionnaire+additive questions (n=5)

  2. use of blood biomarker to predict positive EVH test [ Time Frame: 3 years ]
    blood CC16 levels measured by ELISA

  3. use of sputum biomarker to predict negative EVH test [ Time Frame: 3 years ]
    sputum IL-1 beta mRNA levels measured by q-PCR

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • high-school elite athletes from 'topsportschool' or 'future team'
  • from following disciplines: swimming, basket, volley or foot ball
  • performing at least 12 h sport a week


  • healthy recreational control subjects
  • performing less than 6 hours sport/week

Exclusion Criteria:

- acute infection in four weeks prior to test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587675

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University Hospital of Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen KU Leuven
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Principal Investigator: Dominique MA Bullens, MD, PhD Lab pediatric Immunology, Dep Microbiology and Immunology
Publications of Results:
Other Publications:

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Responsible Party: Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier: NCT03587675    
Other Study ID Numbers: S59778
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Plan from KU Leuven will be followed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchial Spasm
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases