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Role of Airway Hyperresponsiveness on Performance in Elite Swimmers.

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ventolin
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Universitaire de cardiologie et de pneumologie de Québec

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

Inhaled Bronchodilator

Arm Description

Outcomes

Primary Outcome Measures

Bronchodilator versus placebo effects on performance

Secondary Outcome Measures

Measurement of oxidative stress

Full Information

First Posted
April 3, 2009
Last Updated
May 9, 2013
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT00876135
Brief Title
Role of Airway Hyperresponsiveness on Performance in Elite Swimmers.
Official Title
Role of Airway Hyperresponsiveness on Performance in Elite Swimmers: Efficiency of a Bronchodilator to Prevent an Exercise-induced Bronchoconstriction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Bronchodilator
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ventolin
Other Intervention Name(s)
Ventolin (salbutamol)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Bronchodilator versus placebo effects on performance
Time Frame
march to may 2009/ 8 visits
Secondary Outcome Measure Information:
Title
Measurement of oxidative stress
Time Frame
april to June 2009/ 3 visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis-Philippe Boulet, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Universitaire de cardiologie et de pneumologie de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

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Role of Airway Hyperresponsiveness on Performance in Elite Swimmers.

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