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Elite Sport and Development of Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Seretide

Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Sport, Asthma, Treatment, Airway inflammation

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Seretide

Arm Description

Placebo inhaler (sugar powder)

Seretide inhaler

Outcomes

Primary Outcome Measures

Eucapnic voluntary hyperventilation (EVH)

Exhaled Nitric Oxide

Secondary Outcome Measures

Respiratory symptoms

Lung function

Full Information

NCT ID

NCT00262587

First Posted

December 6, 2005

Last Updated

May 15, 2012

Sponsor

Bispebjerg Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00262587

Brief Title

Elite Sport and Development of Asthma

Official Title

Elite Sport and Development of Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bispebjerg Hospital

Collaborators

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

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Sport, Asthma, Treatment, Airway inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo inhaler (sugar powder)

Arm Title

Seretide

Arm Type

Active Comparator

Arm Description

Seretide inhaler

Intervention Type

Drug

Intervention Name(s)

Seretide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Inhaled sugar powder in a placebo inhaler

Primary Outcome Measure Information:

Title

Eucapnic voluntary hyperventilation (EVH)

Time Frame

End of study

Title

Exhaled Nitric Oxide

Time Frame

End of study

Secondary Outcome Measure Information:

Title

Respiratory symptoms

Time Frame

End of study

Title

Lung function

Time Frame

End of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Lund, MD

Organizational Affiliation

Respiratory and Allergy Research Unit, Department of Respiratory Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Copenhagen

ZIP/Postal Code

DK-2400 NV

Country

Denmark

12. IPD Sharing Statement

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Elite Sport and Development of Asthma

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