Clinical trial NCT01942096: Study of Airway Inflammation in Relation to Exercise in Elite Athletes
Official title: Study of Airway Inflammation in Relation to Exercise in Elite Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise Induced Asthma
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 66
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Competitive swimmers, competitive indoor athletes and healthy individuals

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.

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)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Measurement of airway inflammation
timeFrame: Baseline, immediately after and 24 hours after sport-specific training
Secondary outcomes:
measure: Measurement of exercise induced bronchoconstriction
timeFrame: baseline
Other outcomes:
measure: Detection of allergy
timeFrame: baseline
measure: Assessment of upper and lower airway symptoms
timeFrame: Baseline, immediately after and 24 hours after sport-specific training
measure: Measurement of lung function and nasal patency
timeFrame: at baseline, immediately after and 24 hours sport-specific training
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven
name: Sven F Seys, MSc
role: STUDY_DIRECTOR
affiliation: lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven
name: Valerie Hox, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.