Role of Airway Hyperresponsiveness on Performance in Elite Swimmers.

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876135
• Other study ID #: proto nage 2
• Status: Completed
• Phase: N/A
• First received: April 3, 2009
• Last updated: May 9, 2013
• Start date: December 2008
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma
• Respiratory Hypersensitivity

Intervention

Drug:
• Ventolin
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).

Locations

Country	Name	City	State
Canada	Institut Universitaire de cardiologie et de pneumologie de Québec	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchodilator versus placebo effects on performance		march to may 2009/ 8 visits	No
Secondary	Measurement of oxidative stress		april to June 2009/ 3 visits	No