Elite Sport and Development of Asthma

Asthma Clinical Trial

Official title:

Elite Sport and Development of Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262587
• Other study ID #: 2005-061
• Secondary ID: (KF) 01 262958
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2005
• Last updated: May 15, 2012
• Start date: September 2005
• Est. completion date: December 2008

Study information

• Verified date: May 2012
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Seretide
Combination of inhaled corticosteroids (250 microgr) and inhaled long-acting beta2-agonists (25 microgr)
• Placebo
Inhaled sugar powder in a placebo inhaler

Locations

Country	Name	City	State
Denmark	Respiratory and Allergy Research Unit, Department of Respiratory Medicine, Bispebjerg Hospital	Copenhagen

Sponsors (6)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Anti Doping Danmark, GlaxoSmithKline, Imperial College London, Ragnhild Ibsens Legat For Medicinsk Forskning, The Research Foundation of Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eucapnic voluntary hyperventilation (EVH)		End of study	No
Primary	Exhaled Nitric Oxide		End of study	No
Secondary	Respiratory symptoms		End of study	No
Secondary	Lung function		End of study	No