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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
December 6, 2005
December 7, 2005
May 16, 2012
September 2005
December 2008   (Final data collection date for primary outcome measure)
  • Eucapnic voluntary hyperventilation (EVH) [ Time Frame: End of study ]
  • Exhaled Nitric Oxide [ Time Frame: End of study ]
  • Exhaled Nitric Oxide (NO)
  • Eucapnic voluntary hyperventilation (EVH)
Complete list of historical versions of study NCT00262587 on ClinicalTrials.gov Archive Site
  • Respiratory symptoms [ Time Frame: End of study ]
  • Lung function [ Time Frame: End of study ]
  • Respiratory symptoms
  • Lung function
Not Provided
Not Provided
 
Elite Sport and Development of Asthma
Elite Sport and Development of Asthma
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: Seretide
    Combination of inhaled corticosteroids (250 microgr) and inhaled long-acting beta2-agonists (25 microgr)
  • Drug: Placebo
    Inhaled sugar powder in a placebo inhaler
  • Placebo Comparator: Placebo
    Placebo inhaler (sugar powder)
    Intervention: Drug: Placebo
  • Active Comparator: Seretide
    Seretide inhaler
    Intervention: Drug: Seretide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2008
December 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00262587
2005-061
(KF) 01 262958
Not Provided
Not Provided
Not Provided
Thomas Lund, Bispebjerg Hospital
Bispebjerg Hospital
  • Imperial College London
  • Anti Doping Danmark
  • GlaxoSmithKline
  • The Research Foundation of Bispebjerg Hospital
  • Ragnhild Ibsens Legat For Medicinsk Forskning
Principal Investigator: Thomas Lund, MD Respiratory and Allergy Research Unit, Department of Respiratory Medicine
Bispebjerg Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP