NCT04103632

Brief Summary

The purpose of this study is to validate the screening protocol to study risk factors of exercise-induced bronchoconstriction (EIB) obtained in our previous study in high-school elite athletes (NCT03587675), in recreational young athletes who perform intense physical exercise.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2019

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

October 23, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2023

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

3.2 years

First QC Date

August 27, 2019

Last Update Submit

April 20, 2023

Conditions

Young AthletesBiomarkerExercise Induced BronchoconstrictionAdolescent

Keywords

Athletes

Outcome Measures

Primary Outcomes (1)

  • Detection of exercise-induced bronchoconstriction (EIB)

    Assessed by positive eucapnic voluntary hyperventilation (EVH test): at least 10% drop in FEV1% between 5-20' after EVH

    Baseline

Secondary Outcomes (5)

  • Measurement of lung function by standard spirometry: FEV1 (L) and FVC (L)

    Baseline

  • Use of atopy to predict positive EVH test

    Baseline

  • Use of questionnaire to predict positive EVH test

    Baseline

  • Use of fractional exhaled nitric oxide (FeNO) levels to predict positive EVH test

    Baseline

  • Use of blood biomarker to predict positive EVH test

    Baseline

Study Arms (1)

Young recreational athletes (12-18 years)

EXPERIMENTAL

Young recreational athletes (12-18 years) of different sport disciplines: * Indoor sports * Outdoor sports * Swimming * Winter sports

Diagnostic Test: EVH test

Interventions

EVH testDIAGNOSTIC_TEST

* Spirometry * Skin prick test * Peripheral blood test * FeNO measurement

Young recreational athletes (12-18 years)

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Recreational athletes who perform at least 12 hours of sports a week.

You may not qualify if:

  • Acute infection in four weeks prior the test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (5)

  • 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: 26790574BACKGROUND

  • 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: 19346984BACKGROUND

  • 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: 29908073BACKGROUND

  • Jonckheere AC, Seys S, Dilissen E, Schelpe AS, Van der Eycken S, Corthout S, Verhalle T, Goossens J, Vanbelle V, Aertgeerts S, Troosters T, Peers K, Dupont L, Bullens D. Early-onset airway damage in early-career elite athletes: A risk factor for exercise-induced bronchoconstriction. J Allergy Clin Immunol. 2019 Nov;144(5):1423-1425.e9. doi: 10.1016/j.jaci.2019.07.014. Epub 2019 Jul 26. No abstract available.

    PMID: 31356920BACKGROUND

  • 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: 25358760BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Recreational young athletes from different sport disciplines will be tested for lung function, atopy, FeNO, exercise-induced bronchoconstriction (EIB) measured by EVH and biomarkers for EIB will be studied in blood.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2019

First Posted

September 25, 2019

Study Start

October 23, 2019

Primary Completion

January 4, 2023

Study Completion

January 4, 2023

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations

BE(1)