Elite Sport and Development of Asthma

• Sponsor: Bispebjerg Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00262587
• Collaborator: Imperial College London (Other), Anti Doping Danmark (Other), GlaxoSmithKline (Industry), The Research Foundation of Bispebjerg Hospital (Other), Ragnhild Ibsens Legat For Medicinsk Forskning (Other)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Asthma	Drug: Seretide; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Elite Sport and Development of Asthma
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. Eucapnic voluntary hyperventilation (EVH) [End of study]

2. Exhaled Nitric Oxide [End of study]

Secondary Outcome Measures

1. Respiratory symptoms [End of study]

2. Lung function [End of study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Lund, MD, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT00262587
• Other Study ID Numbers: 2005-061; (KF) 01 262958
• First Posted: Dec 7, 2005
• Last Update Posted: May 16, 2012
• Last Verified: May 1, 2012

• Keywords provided by Thomas Lund, MD, Bispebjerg Hospital: Sport; Asthma; Treatment; Airway inflammation
• Additional relevant MeSH terms: Asthma; Fluticasone-Salmeterol Drug Combination

Study Results

No Results Posted as of May 16, 2012