- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00876135
Role of Airway Hyperresponsiveness on Performance in Elite Swimmers.
May 9, 2013 updated by: Louis-Philippe Boulet, Laval University
Role of Airway Hyperresponsiveness on Performance in Elite Swimmers: Efficiency of a Bronchodilator to Prevent an Exercise-induced Bronchoconstriction
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Québec, Quebec, Canada, G1V 4G5
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Inhaled Bronchodilator
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bronchodilator versus placebo effects on performance
Time Frame: march to may 2009/ 8 visits
|
march to may 2009/ 8 visits
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measurement of oxidative stress
Time Frame: april to June 2009/ 3 visits
|
april to June 2009/ 3 visits
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (ACTUAL)
May 1, 2013
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
April 3, 2009
First Submitted That Met QC Criteria
April 3, 2009
First Posted (ESTIMATE)
April 6, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
May 13, 2013
Last Update Submitted That Met QC Criteria
May 9, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Hypersensitivity
- Respiratory Hypersensitivity
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
Other Study ID Numbers
- proto nage 2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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