Study of Airway Inflammation in Relation to Exercise in Elite Athletes

Exercise Induced Asthma Clinical Trial

Official title:

Study of Airway Inflammation in Relation to Exercise in Elite Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942096
• Other study ID #: ML7650
• Status: Completed
• Start date: December 2011
• Est. completion date: August 2013

Study information

• Verified date: July 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma, Exercise-Induced
• Exercise Induced Asthma
• Inflammation

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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 a — View 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 Mar 21. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Detection of allergy	-Allergy will be assessed by skin prick test (on skin) and immunocap test (in blood, 1 tube of 10 ml).	baseline
Other	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)	Baseline, immediately after and 24 hours after sport-specific training
Other	Measurement of lung function and nasal patency	-Lung function and nasal patency will be measured by spirometry and Peak Nasal Inspiratory Flow measurement.	at baseline, immediately after and 24 hours sport-specific training
Primary	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	Measurement of exercise induced bronchoconstriction	Exercise induced bronchoconstriction will be assessed by eucapnic voluntary hyperventilation test.	baseline