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

NCT03587675 | Unknown

• 1 other identifier: S59778
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Induced Bronchospasm; Athletes; Adolescent

Outcome Measures

Primary Outcomes (1)

• incidence of athletes with exercise-induced bronchospasm

  measured by positive EVH test: at least 10% drop in FEV1% between 5-20' after EVH

  2 years

Secondary Outcomes (3)

• use of questionnaire to predict positive EVH test

  2 years

• use of blood biomarker to predict positive EVH test

  3 years

• use of sputum biomarker to predict negative EVH test

  3 years

Study Arms (1)

EVH in high-school elite athletes

OTHER

EVH-test, skin prick test, sputum induction in all subjects Interventional but no drug or device tested

Diagnostic Test: EVH test

Interventions

EVH test DIAGNOSTIC_TEST

Also known as: sputum induction, skin prick test, peripheral blood test, nasal lavage

EVH in high-school elite athletes

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- acute infection in four weeks prior to test

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospital of Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (27)

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  PMID: 24130669 BACKGROUND

• Rundell KW, Slee JB. Exercise and other indirect challenges to demonstrate asthma or exercise-induced bronchoconstriction in athletes. J Allergy Clin Immunol. 2008 Aug;122(2):238-46; quiz 247-8. doi: 10.1016/j.jaci.2008.06.014.

  PMID: 18678339 BACKGROUND

• Chateaubriand do Nascimento Silva Filho MJ, Goncalves AV, Tavares Viana M, Peixoto DM, Cavalcanti Sarinho ES, Rizzo JA. Exercise-induced bronchoconstriction diagnosis in asthmatic children: comparison of treadmill running and eucapnic voluntary hyperventilation challenges. Ann Allergy Asthma Immunol. 2015 Oct;115(4):277-81. doi: 10.1016/j.anai.2015.07.009. Epub 2015 Aug 1.

  PMID: 26238422 BACKGROUND

• Anderson SD, Argyros GJ, Magnussen H, Holzer K. Provocation by eucapnic voluntary hyperpnoea to identify exercise induced bronchoconstriction. Br J Sports Med. 2001 Oct;35(5):344-7. doi: 10.1136/bjsm.35.5.344.

  PMID: 11579071 BACKGROUND

• Castricum A, Holzer K, Brukner P, Irving L. The role of the bronchial provocation challenge tests in the diagnosis of exercise-induced bronchoconstriction in elite swimmers. Br J Sports Med. 2010 Aug;44(10):736-40. doi: 10.1136/bjsm.2008.051169. Epub 2008 Oct 23.

  PMID: 18948353 BACKGROUND

• Hull JH, Ansley L, Price OJ, Dickinson JW, Bonini M. Eucapnic Voluntary Hyperpnea: Gold Standard for Diagnosing Exercise-Induced Bronchoconstriction in Athletes? Sports Med. 2016 Aug;46(8):1083-93. doi: 10.1007/s40279-016-0491-3.

  PMID: 27007599 BACKGROUND

• Bonini M, Braido F, Baiardini I, Del Giacco S, Gramiccioni C, Manara M, Tagliapietra G, Scardigno A, Sargentini V, Brozzi M, Rasi G, Bonini S. AQUA: Allergy Questionnaire for Athletes. Development and validation. Med Sci Sports Exerc. 2009 May;41(5):1034-41. doi: 10.1249/MSS.0b013e318193c663.

  PMID: 19346984 BACKGROUND

• Truyen E, Coteur L, Dilissen E, Overbergh L, Dupont LJ, Ceuppens JL, Bullens DM. Evaluation of airway inflammation by quantitative Th1/Th2 cytokine mRNA measurement in sputum of asthma patients. Thorax. 2006 Mar;61(3):202-8. doi: 10.1136/thx.2005.052399. Epub 2006 Jan 31.

  PMID: 16449261 BACKGROUND

• Bullens DM, Truyen E, Coteur L, Dilissen E, Hellings PW, Dupont LJ, Ceuppens JL. IL-17 mRNA in sputum of asthmatic patients: linking T cell driven inflammation and granulocytic influx? Respir Res. 2006 Nov 3;7(1):135. doi: 10.1186/1465-9921-7-135.

  PMID: 17083726 BACKGROUND

• Bullens DM, Decraene A, Dilissen E, Meyts I, De Boeck K, Dupont LJ, Ceuppens JL. Type III IFN-lambda mRNA expression in sputum of adult and school-aged asthmatics. Clin Exp Allergy. 2008 Sep;38(9):1459-67. doi: 10.1111/j.1365-2222.2008.03045.x. Epub 2008 Jun 28.

  PMID: 18564328 BACKGROUND

• Grabowski M, Kasran A, Seys S, Pauwels A, Medrala W, Dupont L, Panaszek B, Bullens D. Pepsin and bile acids in induced sputum of chronic cough patients. Respir Med. 2011 Aug;105(8):1257-61. doi: 10.1016/j.rmed.2011.04.015. Epub 2011 May 17.

  PMID: 21592756 BACKGROUND

• Bobic S, Seys S, De Vooght V, Callebaut I, Hox V, Dooms C, Vinckier S, Jonckx B, Saint-Remy JM, Stassen JM, Bullens DM, Ceuppens JL, Carmeliet P, Hellings PW. Placental growth factor contributes to bronchial neutrophilic inflammation and edema in allergic asthma. Am J Respir Cell Mol Biol. 2012 Jun;46(6):781-9. doi: 10.1165/rcmb.2011-0152OC. Epub 2012 Jan 20.

  PMID: 22268141 BACKGROUND

• Grabowski M, Seys S, Decraene A, Kasran A, Dilissen E, Barg W, Medrala W, Dupont LJ, Panaszek B, Bullens DM. Airway inflammation in patients with chronic non-asthmatic cough. Thorax. 2013 Feb;68(2):125-30. doi: 10.1136/thoraxjnl-2012-201895. Epub 2012 Oct 23.

  PMID: 23093651 BACKGROUND

• Seys SF, Grabowski M, Adriaensen W, Decraene A, Dilissen E, Vanoirbeek JA, Dupont LJ, Ceuppens JL, Bullens DM. Sputum cytokine mapping reveals an 'IL-5, IL-17A, IL-25-high' pattern associated with poorly controlled asthma. Clin Exp Allergy. 2013 Sep;43(9):1009-17. doi: 10.1111/cea.12125.

  PMID: 23957336 BACKGROUND

• Marijsse GS, Seys SF, Schelpe AS, Dilissen E, Goeminne P, Dupont LJ, Ceuppens JL, Bullens DM. Obese individuals with asthma preferentially have a high IL-5/IL-17A/IL-25 sputum inflammatory pattern. Am J Respir Crit Care Med. 2014 May 15;189(10):1284-5. doi: 10.1164/rccm.201311-2011LE. No abstract available.

  PMID: 24832749 BACKGROUND

• Steelant B, Hox V, Van Gerven L, Dilissen E, Dekimpe E, Kasran A, Aertgeerts S, Van Belle V, Peers K, Dupont LJ, Hellings PW, Bullens DM, Seys SF. Nasal symptoms, epithelial injury and neurogenic inflammation in elite swimmers. Rhinology. 2018 Sep 1;56(3):279-287. doi: 10.4193/Rhin17.167.

  PMID: 29561921 BACKGROUND

• Seys SF, Hox V, Van Gerven L, Dilissen E, Marijsse G, Peeters E, Dekimpe E, Kasran A, Aertgeerts S, Troosters T, Vanbelle V, Peers K, Ceuppens JL, Hellings PW, Dupont LJ, Bullens DM. Damage-associated molecular pattern and innate cytokine release in the airways of competitive swimmers. Allergy. 2015 Feb;70(2):187-94. doi: 10.1111/all.12540.

  PMID: 25358760 RESULT

• Van der Eycken S, Schelpe A, Marijsse G, Dilissen E, Troosters T, Vanbelle V, Aertgeerts S, Dupont LJ, Peers K, Bullens DM, Seys SF. Feasibility to apply eucapnic voluntary hyperventilation in young elite athletes. Respir Med. 2016 Feb;111:91-3. doi: 10.1016/j.rmed.2015.12.012. Epub 2016 Jan 4.

  PMID: 26790574 RESULT

• Jonckheere AC, Seys SF, Dilissen E, Marijsse G, Schelpe AS, Van der Eycken S, Verhalle T, Vanbelle V, Aertgeerts S, Troosters T, Peers K, Dupont LJ, Bullens DMA. AQUA(c) Questionnaire as prediction tool for atopy in young elite athletes. Pediatr Allergy Immunol. 2018 Sep;29(6):648-650. doi: 10.1111/pai.12949. Epub 2018 Jul 9. No abstract available.

  PMID: 29908073 RESULT

• Goossens J, Jonckheere AC, Seys SF, Dilissen E, Decaesteker T, Goossens C, Peers K, Vanbelle V, Stappers J, Aertgeerts S, De Wilde B, Leus J, Verelst S, Raes M, Dupont L, Bullens DM. Activation of epithelial and inflammatory pathways in adolescent elite athletes exposed to intense exercise and air pollution. Thorax. 2023 Aug;78(8):775-783. doi: 10.1136/thorax-2022-219651. Epub 2023 Mar 16.

  PMID: 36927754 DERIVED

MeSH Terms

Conditions

Asthma, Exercise-Induced

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Dominique MA Bullens, MD, PhD

  Lab pediatric Immunology, Dep Microbiology and Immunology

  PRINCIPAL INVESTIGATOR

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: 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

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 16, 2018
• Study Start: January 1, 2017
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2022
• Last Updated: November 5, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)