Elite Sport and Development of Asthma

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2007 by Bispebjerg Hospital. Recruitment status was Recruiting

First Received on December 6, 2005. Last Updated on November 2, 2007 History of Changes

Sponsor:	Bispebjerg Hospital
Collaborators:	Imperial College London Anti Doping Danmark GlaxoSmithKline The Research Foundation of Bispebjerg Hospital Ragnhild Ibsens Legat for Medicinsk Forskning
Information provided by:	Bispebjerg Hospital
ClinicalTrials.gov Identifier:	NCT00262587

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	Phase IV

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)
Exhaled Nitric Oxide

Secondary Outcome Measures:

Respiratory symptoms
Lung function

Estimated Enrollment:	40
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2008

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

Contacts

Contact: Thomas Lund, MD	(+45) 35316820	tclund21@hotmail.com
Contact: Vibeke Backer, MD	(+45) 35313569

Locations

Denmark
Respiratory and Allergy Research Unit, Department of Respiratory Medicine, Bispebjerg Hospital	Recruiting
Copenhagen, Denmark, DK-2400 NV
Contact: Thomas Lund, MD (+45) 35316820 tclund21@hotmail.com
Principal Investigator: Thomas Lund, MD

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

ClinicalTrials.gov Identifier:	NCT00262587 History of Changes
Other Study ID Numbers:	2005-061, (KF) 01 262958
Study First Received:	December 6, 2005
Last Updated:	November 2, 2007
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 February 09, 2012