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Elite Sport and Development of Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00262587
First Posted: December 7, 2005
Last Update Posted: May 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Imperial College London
Anti Doping Danmark
GlaxoSmithKline
The Research Foundation of Bispebjerg Hospital
Ragnhild Ibsens Legat For Medicinsk Forskning
Information provided by (Responsible Party):
Thomas Lund, Bispebjerg Hospital
  Purpose
International studies have shown that elite athletes have a high prevalence of respiratory symptoms and asthma as compared to normal subjects. It is unclear whether the increased prevalence of asthma in elite athletes reflects "traditional asthma" or whether it is a special form of "sports asthma". The treatment of elite athletes with asthma seems to vary widely, and only a few studies have focused on the treatment of elite athletes with asthma. Further knowledge of the pathogenesis of sports asthma would lead to a greater understanding and better treatment of the condition. This study will investigate the type of airway inflammation in elite athletes and examine the effect of treatment with inhaled steroids in combination with long-acting beta-agonists versus placebo in the same group.

Condition Intervention Phase
Asthma Drug: Seretide Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Elite Sport and Development of Asthma

Further study details as provided by Thomas Lund, Bispebjerg Hospital:

Primary Outcome Measures:
  • Eucapnic voluntary hyperventilation (EVH) [ Time Frame: End of study ]
  • Exhaled Nitric Oxide [ Time Frame: End of study ]

Secondary Outcome Measures:
  • Respiratory symptoms [ Time Frame: End of study ]
  • Lung function [ Time Frame: End of study ]

Enrollment: 18
Study Start Date: September 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo inhaler (sugar powder)
Drug: Placebo
Inhaled sugar powder in a placebo inhaler
Active Comparator: Seretide
Seretide inhaler
Drug: Seretide
Combination of inhaled corticosteroids (250 microgr) and inhaled long-acting beta2-agonists (25 microgr)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elite athletes
  • Informed consent
  • Doctor diagnosed asthma

Exclusion Criteria:

  • Current smoker or more than 10 pack-years
  • Pregnancy, breast feeding or planning pregnancy during the study.
  • ICS within the last 4 weeks prior to visit 1.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262587


Locations
Denmark
Respiratory and Allergy Research Unit, Department of Respiratory Medicine, Bispebjerg Hospital
Copenhagen, Denmark, DK-2400 NV
Sponsors and Collaborators
Bispebjerg Hospital
Imperial College London
Anti Doping Danmark
GlaxoSmithKline
The Research Foundation of Bispebjerg Hospital
Ragnhild Ibsens Legat For Medicinsk Forskning
Investigators
Principal Investigator: Thomas Lund, MD Respiratory and Allergy Research Unit, Department of Respiratory Medicine
  More Information

Responsible Party: Thomas Lund, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00262587     History of Changes
Other Study ID Numbers: 2005-061
(KF) 01 262958
First Submitted: December 6, 2005
First Posted: December 7, 2005
Last Update Posted: May 16, 2012
Last Verified: May 2012

Keywords provided by Thomas Lund, Bispebjerg Hospital:
Sport
Asthma
Treatment
Airway inflammation

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics