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CompletedNCT01942096Updated Jul 16, 2018

Study of Airway Inflammation in Relation to Exercise in Elite Athletes

An observational study in Exercise Induced Asthma, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 14 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-16.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
14 Years to 25 Years
Sex
All
01

Study summary

High school elite training programs are today more and more under development in several 'elite sport schools' in Belgium, in order to select and train future elite athletes already at young age. Little is known about the effects of sustained training on the potential development of asthma in adolescents during lung growth. It would be of great importance to be able to select the individuals at risk to develop exercise-induced asthma, already at the start of their enrollment in the 'elite sport school. 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 exercise-induced asthma.

Read the detailed description

Competitive swimmers, competitive indoor athletes and control individuals performing sports at a recreational level will be recruited for the study.

They will perform a sport-specific training (swimmers and controls: swimming for 90 minutes, indoor athletes: basketball or volleyball for 90 minutes)

Baseline measurements:

  • Airway inflammation upper and lower airways will be assessed by collection of nasal fluid (nasal sponge will be inserted in nostril for 5 minutes), Fraction of exhaled Nitric Oxide measurement and sputum induction.
  • Upper and lower airway symptoms will be assessed by questionnaires (SinoNasal Outcome Measure-22, Visual Analogue Score, Asthma Symptom Score and Juniper Score)
  • Allergy will be assessed by skin prick test (on skin) and immunocap test (in blood, 1 tube of 10 ml).
  • Lung function and nasal patency will be measured by spirometry and Peak Nasal Inspiratory Flow measurement.
  • Exercise induced bronchoconstriction will be assessed by eucapnic voluntary hyperventilation test.

Measurements immediately after training:

  • Collection of nasal fluid
  • Assessment of upper airway symptoms (Visual Analogue Score)
  • Spirometry and Fraction of Exhaled Nitric Oxide measurement
  • Peak Nasal Inspiratory Flow measurement

Measurements 24 hours after training:

  • Collection of nasal fluid
  • Assessment of upper airway symptoms (Visual Analogue Score)
  • Spirometry and Fraction of Exhaled Nitric Oxide measurement
  • Peak Nasal Inspiratory Flow measurement
  • Sputum induction
  • Venous puncture (1 tube of 10 ml)
02

Conditions studied

  • Exercise Induced Asthma
03

In context

Asthma, Exercise-Induced

52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.

Browse Asthma, Exercise-Induced studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Competitive swimmers, competitive indoor athletes and healthy individuals

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Performing sports at national or international level (swimmers and indoor athletes)

Exclusion criteria

Exclusion Criteria:

  • Performing sport at recreational level (not more than 4 hours/week for healthy individuals)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Competitive swimmers

    Swimmers performing at national or international level

  • Competitive indoor athletes

    Indoor athletes performing at national or international level

  • Healthy control individuals

    Individuals performing sports at a recreational level

06

What researchers measure

Primary outcomes

  1. Measurement of airway inflammation

    Airway inflammation upper and lower airways will be assessed by collection of nasal fluid (nasal sponge will be inserted in nostril for 5 minutes), Fraction of exhaled Nitric Oxide measurement and sputum induction.

    Time frame: Baseline, immediately after and 24 hours after sport-specific training

Secondary outcomes

  1. Measurement of exercise induced bronchoconstriction

    Exercise induced bronchoconstriction will be assessed by eucapnic voluntary hyperventilation test.

    Time frame: baseline

Other outcomes

  1. Detection of allergy

    -Allergy will be assessed by skin prick test (on skin) and immunocap test (in blood, 1 tube of 10 ml).

    Time frame: baseline

  2. Assessment of upper and lower airway symptoms

    -Upper and lower airway symptoms will be assessed by questionnaires (SinoNasal Outcome Measure-22, Visual Analogue Score, Asthma Symptom Score and Juniper Score)

    Time frame: Baseline, immediately after and 24 hours after sport-specific training

  3. Measurement of lung function and nasal patency

    -Lung function and nasal patency will be measured by spirometry and Peak Nasal Inspiratory Flow measurement.

    Time frame: at baseline, immediately after and 24 hours sport-specific training

07

Study locations

1 site
  • UZ Leuven
    Leuven, Vlaams-Brabant 3000, Belgium
08

References and documents

Publications

  • 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. PubMed 29561921 ↗
  • 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. PubMed 25358760 ↗

Individual participant data

Plan to share: Yes — Overall results are presented in a closed session for participants and parents. Confidential individual data are afterwards discussed with the respective parents and participants.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01942096
Responsible party
Dominque Bullens (prof dr, Universitaire Ziekenhuizen KU Leuven) — Principal investigator
First posted
Sep 13, 2013
Start date
Dec 2011
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Jul 16, 2018

Study contacts

Sven F Seys, MSc
study director · lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven
Valerie Hox, MD
study director · lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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