Clinical trial NCT02432183: Longitudinal Follow-up of High School Athletes
Official title: Longitudinal Follow-up of Exercise-induced Bronchoconstriction and Airway Inflammation in High School Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elite Athlete
Healthy
Keywords: individual
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 134
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A group of elite athletes at the start of their career (both from the elite sport school in Wilrijk (n=15) and Leuven (n=35) in cooperation with 'Sportmedisch Advies Centrum' (SMAC) UZ Leuven) are recruited. Three sport disciplines are included: basketball players, football players and swimmers.

A group of healthy subjects (n=20) is recruited to serve as a control.

Brief summary: In this study the investigators will study the lung function and airway inflammation in elite athletes starting at the elite sport school (age: 12-13 year) and the change in lung function parameters and airway inflammation after 1 and 2 years at the elite sport school in comparison to age-matched controls (exercising at a recreational level, \<4 hours/week).

Detailed description: A group of elite athletes (from the elite sport school in Leuven (n=35) in cooperation with 'Sportmedisch Advies Centrum' (SMAC) UZ Leuven) and the future team of the Flemish Swimming Federation (n=15) will be recruited at the start of their career (first level) as an elite athlete. A group of healthy subjects (n=20) will be recruited to serve as a control.

The investigators will compare lung function parameters and airway inflammation at the first visit in the autumn of 2011 and the second and third visit (one and two years later, respectively).

Lung function will be assessed by spirometry. Sputum will be induced with an aerosol of inhaled hypertonic saline in concentrations of 3%, 4% and 5% for 7 minutes generated by a De Vilbiss nebuliser (Ultra-Neb 2000 model 200HI) after pretreatment with 400 mg inhaled salbutamol. Sputum will be processed as previously described and the obtained cell suspensions will be used for differential cell counts and cytokine mRNA analysis. The supernatant will be used to measure cytokine and chemokine levels.

EIA diagnosis (visit 1,2 and 3) will be assessed by a diagnostic test for asthma (positive reversibility test with salbutamol) and a positive EIB-test. Eucapnic voluntary hyperventilation test will be used as a test for EIB (gold standard of IOC-MC). Dynamic lung function parameters will be assessed before and immediately after, 5' after, 10' after and 15' after eucapnic hyperventilation. Patients were asked to breath at 85% of the maximal ventilation (predefined as maximal voluntary volume) for 6 minutes through a mouthpiece connected to a reservoir. The reservoir is be filled with a gas mixture of 21% 02, 5% CO2 and 74% N2. The test is considered positive when a drop in FEV1 of \>10% occurred at one of the time points after eucapnic hyperventilation.

Eligibility criteria: Inclusion Criteria:

* Elite athletes from the elite sport school in Wilrijk and Leuven
* First grade of high school

Exclusion Criteria:

* Performing \>4hours/week sports

Primary outcomes:
measure: Maximal Fall in Forced Expiratory Volume in One-second (FEV1) After Eucapnic Voluntary Hyperventilation (EVH) Test
timeFrame: change from baseline compared to 15 minutes after EVH test
Secondary outcomes:
measure: Number of Participants With Allergies Determined by Positive Skin Prick Test
timeFrame: baseline
Other outcomes:
measure: Number of Sputum Uric Acid-high Subjects (Determined by ELISA on Sputum Supernatants)
timeFrame: baseline
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.