Elite Sport and Development of Asthma

NCT00262587 | Completed Phase 4

• 2 other identifiers: 2005-061(KF) 01 262958
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Sport; Asthma; Treatment; Airway inflammation

Outcome Measures

Primary Outcomes (2)

• Eucapnic voluntary hyperventilation (EVH)

  End of study

• Exhaled Nitric Oxide

  End of study

Secondary Outcomes (2)

• Respiratory symptoms

  End of study

• Lung function

  End of study

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo inhaler (sugar powder)

Drug: Placebo

Seretide

ACTIVE COMPARATOR

Seretide inhaler

Drug: Seretide

Interventions

Seretide DRUG

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

Seretide

Placebo DRUG

Inhaled sugar powder in a placebo inhaler

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Elite athletes
• Informed consent
• Doctor diagnosed asthma

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Copenhagen, DK-2400 NV, Denmark

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Thomas Lund, MD

  Respiratory and Allergy Research Unit, Department of Respiratory Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 7, 2005
• Study Start: September 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

DK (1)