Screening and Diagnosing Exercise-induced Bronchoconstriction in Recreational Young Athletes (12-18 y)

April 20, 2023 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Physical exercise, though absolutely beneficial for human well-being, is a well-known trigger to induce bronchoconstriction. Exercise can provoke bronchoconstriction in subjects with pre-existing asthma but can also induce bronchoconstriction in otherwise healthy subjects. The latter phenomenon is called exercise-induced bronchoconstriction (EIB). EIB is frequent in the general population and might affect between 5 and 10% of them, although population based reports are scarce. EIB is most prevalent in individuals performing endurance sport disciplines, such as long distance running, duathlon and triathlon, cycling and cross-country skiing. Due to frequent intense physical training, its incidence is higher in elite athletes compared to non-elite athletes. Its prevalence in elite athletes within these endurance sport disciplines is estimated to be up to 13%. The percentage in aquatic endurance sports was surprisingly even higher and reached 20% in the Olympic games of 2008. Besides intense physical training, environmental factors such as chlorine or cold air exposure are therefore also linked to the appearance of EIB.

It remains very difficult to screen all athletes yearly for EIB. Therefore, the goal of this study is to define risk factors and/or biomarkers that might predict EIB, already at the start of their sport career. This would allow physicians to follow their lung function parameters very closely and regularly; and, if necessary, start treatment early after the first signs of EIB.

The investigators already found that atopic individuals in a young cohort of elite athletes (12-13y) had increased risk to test positive for EIB (Fisher exact test p=0.04). However, due to the high number of subjects with a positive EIB test but negative Atopy/AQUA questionnaire, the AQUA questionnaire by itself can't be used to predict EIB (p=0.4). However, one out of five questions added by our group to this questionnaire ("Do the participant suffer from wheeze during exercise?") by itself predicted EIB with 93% specificity and 24% sensitivity. Adding a second question to this ("Has a doctor ever diagnosed the participant with an allergic condition?") increased the specificity to predict a positive EIB test to 99% but lowered sensitivity to 15% only (Jonckheere AC, J Allergy Clin Immunol, 2019). Based on the preliminary data of the slightly older cohort of also elite athletes (13-18 y), fractional exhaled nitric oxide (FeNO) levels (cut off 16 ppb) may be a useful indicator of atopic phenotypes among young elite athletes. Whether atopy is a risk factor for EIB in recreational young athletes who perform intense physical exercise has to be further studied.

Hypothesis: The investigators hypothesize that the findings in the cohort of elite athletes will be similar in the cohort of recreational athletes, performing at least 12 hours of sport a week. This means that:

  • They hypothesize that questionnaires (including AQUA questionnaire) can be used to screen for EIB
  • They hypothesize that atopy will be a risk factor for EIB
  • They hypothesize that increased FeNO levels will be a risk factor for EIB
  • They hypothesize that adding blood based biomarkers increase the predictive value of the screening protocol

Aim of the study: Therefore the aim of the study is to validate the screening protocol and diagnostic EIB test in a powered (n=500) group of recreational adolescent athletes who perform their sports at least 12h/week.

Material and method: 500 recreational athletes who perform at least 12 hours of sports a week will be recruited amongst different youth sport branches including indoor sports, outdoor sports, swimming and even winter sports. Subjects will be contacted in collaboration with their local sport doctors. Subjects from East-and West Flanders will be studied at AZ Maria Middelares in Ghent by dr J Leus, subjects from Limburg will be studied at the Jessa Hospital in Hasselt and subjects from Antwerp and Flemish-Brabant will be studied in Leuven, UZ Gasthuisberg in close collaboration with prof L Dupont, copromotor of the study.

Measurements at the visit:

  • Lung function will be assessed by spirometry.
  • Questionnaires, including the AQUA questionnaire
  • Atopy will be assessed by skin prick test for common environmental allergens
  • Fractional exhaled Nitric Oxide (FeNO) measurement
  • Venous puncture (1 tube)
  • Eucapnic voluntary hyperventilation (EVH) test will be used as a test for EIB (adapted for this young age).

Statistical analysis: Power analysis to study the sample size has been performed based on the previous study in first grade elite athletes. Atopy was present in 35% of the subjects and EVH test was positive in 27% of these atopic subjects and 12.5% in non-atopic subjects. Probably atopy rate was accidently higher than expected in the general population (25%) Therefore a sample size of 405 subjects would allow to predict the presence of atopy and EIB with a type I error rate of 0.05 as well as a type II error rate of 0.05 at a power of 95%. The investigators expect drop-out of 15-20% of the subjects (which is more than the investigators observed in elite athletes, but consider their willingness to adhere at a screening protocol in elite athletes to be higher than that in non-elite athletes), aiming to recruit 500 subjects.

Feasibility: FWO-TBM study budget granted

Study Type

Interventional

Enrollment (Actual)

346

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • University Hospital of Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute infection in four weeks prior the test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Young recreational athletes (12-18 years)

Young recreational athletes (12-18 years) of different sport disciplines:

  • Indoor sports
  • Outdoor sports
  • Swimming
  • Winter sports
Diagnostic test: EVH test
  • Spirometry
  • Skin prick test
  • Peripheral blood test
  • FeNO measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of exercise-induced bronchoconstriction (EIB)
Time Frame: Baseline
Assessed by positive eucapnic voluntary hyperventilation (EVH test): at least 10% drop in FEV1% between 5-20' after EVH
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of lung function by standard spirometry: FEV1 (L) and FVC (L)
Time Frame: Baseline
Determination of lung obstruction based on Tiffeneau-index: FEV1(L)/FVC(L). FVC is the volume of air that can forcibly be blown out after full inspiration. FEV1 is the volume of air that can forcibly be blown out in the first second, after full inspiration. In obstructive diseases (like asthma), the tiffeneau index is reduced (<80%).
Baseline
Use of atopy to predict positive EVH test
Time Frame: Baseline
Atopy will be assessed by a positive skin prick test
Baseline
Use of questionnaire to predict positive EVH test
Time Frame: Baseline
AQUA questionnaire + additive questions An AQUA© score ≥ 6 is proposed to predict atopy in young elite athletes. In the presence of 1 or 2 additional questions (e.g. Do you suffer from wheeze during exercise?) , the specificity to point to the risk for EIB could improve.
Baseline
Use of fractional exhaled nitric oxide (FeNO) levels to predict positive EVH test
Time Frame: Baseline
FeNO levels in parts per billion (PPB)
Baseline
Use of blood biomarker to predict positive EVH test
Time Frame: Baseline
Blood CC16 levels measured by ELISA
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Jessa Hospital
Algemeen Ziekenhuis Maria Middelares

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2019

Primary Completion (Actual)

January 4, 2023

Study Completion (Actual)

January 4, 2023

Study Registration Dates

First Submitted

August 27, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S61602

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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