NCT01942096

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2011

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

Study Start

First participant enrolled

December 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

August 26, 2013

Last Update Submit

July 12, 2018

Conditions

Outcome Measures

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.

    Baseline, immediately after and 24 hours after sport-specific training

Secondary Outcomes (1)

  • Measurement of exercise induced bronchoconstriction

    baseline

Other Outcomes (3)

  • Detection of allergy

    baseline

  • Assessment of upper and lower airway symptoms

    Baseline, immediately after and 24 hours after sport-specific training

  • Measurement of lung function and nasal patency

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

Study Arms (3)

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

Eligibility Criteria

Age14 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Competitive swimmers, competitive indoor athletes and healthy individuals

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (2)

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

induced sputum sample nasal fluid venous blood (serum)

MeSH Terms

Conditions

Asthma, Exercise-Induced

Condition Hierarchy (Ancestors)

AsthmaBronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityExercise-Induced AllergiesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Sven F Seys, MSc

    lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven

    STUDY DIRECTOR
  • Valerie Hox, MD

    lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof dr

Study Record Dates

First Submitted

August 26, 2013

First Posted

September 13, 2013

Study Start

December 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

July 16, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

Overall results are presented in a closed session for participants and parents. Confidential individual data are afterwards discussed with the respective parents and participants.

Locations