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Elite Sport and Development of Asthma

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00262587
First received: December 6, 2005
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  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 Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Elite Sport and Development of Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Eucapnic voluntary hyperventilation (EVH) [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Exhaled Nitric Oxide [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Respiratory symptoms [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Lung function [ Time Frame: End of study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Thomas Lund, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00262587     History of Changes
Other Study ID Numbers: 2005-061, (KF) 01 262958
Study First Received: December 6, 2005
Last Updated: May 15, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by 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, salmeterol drug combination
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013