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Completed

NCT Number: NCT00262587

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.

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Key information

Conditions

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

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Respiratory and Allergy Research Unit, Department of Respiratory Medicine, Bispebjerg Hospital

Copenhagen, DK-2400 NV, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Seretide

Drug

Combination of inhaled corticosteroids (250 microgr) and inhaled long-acting beta2-agonists (25 microgr)

Placebo

Drug

Inhaled sugar powder in a placebo inhaler

Primary outcomes

  1. Eucapnic voluntary hyperventilation (EVH)

    Time frame: End of study

  2. Exhaled Nitric Oxide

    Time frame: End of study

Secondary outcomes

  1. Respiratory symptoms

    Time frame: End of study

  2. Lung function

    Time frame: End of study

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Anti Doping Danmark
  • GlaxoSmithKline
  • Imperial College London
  • Ragnhild Ibsens Legat For Medicinsk Forskning
  • The Research Foundation of Bispebjerg Hospital

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 7, 2005
Registry last updated
May 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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