Role of Airway Hyperresponsiveness on Performance in Elite Swimmers.

NCT00876135 | Completed DMC

• 1 other identifier: proto nage 2
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Bronchodilator versus placebo effects on performance

  march to may 2009/ 8 visits

Secondary Outcomes (1)

• Measurement of oxidative stress

  april to June 2009/ 3 visits

Study Arms (1)

Inhaled Bronchodilator

PLACEBO COMPARATOR

Drug: Ventolin

Interventions

Ventolin DRUG

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).

Also known as: Ventolin (salbutamol)

Inhaled Bronchodilator

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Swimmer (at least 10h/week) aged from at least 14 years.

You may not qualify if:

• Smoker, obese or other disease which may interfere with the study. Some parts of the study may exclude swimmers taking inhaled corticosteroids.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut Universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Louis-Philippe Boulet, MD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 6, 2009
• Study Start: December 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

CA (1)