Role of Airway Hyperresponsiveness on Performance in Elite Swimmers.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louis-Philippe Boulet, Laval University
ClinicalTrials.gov Identifier:
NCT00876135
First received: April 3, 2009
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Asthma
Drug: Ventolin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Role of Airway Hyperresponsiveness on Performance in Elite Swimmers: Efficiency of a Bronchodilator to Prevent an Exercise-induced Bronchoconstriction

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Bronchodilator versus placebo effects on performance [ Time Frame: march to may 2009/ 8 visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of oxidative stress [ Time Frame: april to June 2009/ 3 visits ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: December 2008
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Inhaled Bronchodilator 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).
Other Name: Ventolin (salbutamol)

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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00876135

Locations
Canada, Quebec
Institut Universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Louis-Philippe Boulet, MD Laval University
  More Information

No publications provided

Responsible Party: Louis-Philippe Boulet, MD, Laval University
ClinicalTrials.gov Identifier: NCT00876135     History of Changes
Other Study ID Numbers: proto nage 2
Study First Received: April 3, 2009
Last Updated: May 9, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 20, 2014