Role of Airway Hyperresponsiveness on Performance in Elite Swimmers.

Study Overview
=================
Brief Summary
-----------------
The prevalence of airway hyperresponsiveness (AHR) is very high in elite swimmers, reaching 80% in certain studies. Repeated Chlorine-derivatives exposure may be a major causative factor for its development. Asthma diagnosis is generally made on the basis of clinical characteristics. The demonstration of a variable bronchial obstruction through positive expiratory flow reversibility to a bronchodilator, spontaneous variations of airway obstruction or a positive provocation test (methacholine, eucapnic voluntary hyperpnoea…) is necessary to avoid false diagnosis. Currently asthma treatment in swimmers is the same as in the general population. A short-acting bronchodilator is often prescribed to avoid occasional symptoms, combined with an inhaled corticosteroid or an antagonist of Leukotriene if asthma symptoms are persistent. Previous studies have shown a reduced efficiency for asthma medication in elite athletes compared with non-athletes. The specific response to different medications remains to be studied in athletes. The effects of a short-acting bronchodilator in swimmers with AHR, especially when asymptomatic, on pulmonary function and performance have not yet been studied. Moreover, the significance of a positive bronchial provocation test remains to be studied in asymptomatic swimmers with AHR.

Detailed Description
-----------------
Our hypothesis is that swimmers with a positive bronchial provocation challenge have not necessarily an exercise-induced bronchoconstriction during swimming and the use of a bronchodilator will be unnecessary. Chlorine-derivatives exposure may be responsible for a weakness of the epithelium layer but warm and humid atmosphere of the swimming-pools may be protective for the development of a bronchoconstriction. Thus we also hypothesis that during a field test outside the swimming pool, swimmers will develop an exercise-induced asthma, and will need to take a bronchodilator in prevention.

Official Title
-----------------
Role of Airway Hyperresponsiveness on Performance in Elite Swimmers: Efficiency of a Bronchodilator to Prevent an Exercise-induced Bronchoconstriction

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Ventolin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Swimmer (at least 10h/week) aged from at least 14 years. Exclusion Criteria: Smoker, obese or other disease which may interfere with the study. Some parts of the study may exclude swimmers taking inhaled corticosteroids.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Inhaled Bronchodilator<br> | Drug: Ventolin<br>* Ventolin or Placebo will be given before the 4 field tests (2 with ventolin in prevention and 2 with placebo in prevention) and 2 eucapnic voluntary hyperpnoea tests (one preceded by Ventolin and one preceded by Placebo).<br>* Other names: Ventolin (salbutamol);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchodilator versus placebo effects on performance |  | march to may 2009/ 8 visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of oxidative stress |  | april to June 2009/ 3 visits |