Elite Sport and Development of Asthma | NCT00262587

Studies
Elite Sport and Development of Asthma

NCT00262587

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

May 16, 2012Estimated

Enrollment

18Actual

Phase

Phase 4

Conditions

Asthma

Interventions

Seretide
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
(KF) 01 262958

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Dec 6, 2005

First Submission Date that Met QC Criteria

Dec 6, 2005

First Posted Date

Dec 7, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2012

Last Update Posted Date

May 16, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas Lund, MD, Bispebjerg HospitalPrincipal Investigator

Lead Sponsor

Bispebjerg HospitalOTHER

Collaborators

Name	Class
Imperial College London	OTHER
Anti Doping Danmark	OTHER
GlaxoSmithKline	INDUSTRY
The Research Foundation of Bispebjerg Hospital

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo inhaler (sugar powder)	Drug: Placebo
Seretide	Active Comparator	Seretide inhaler	Drug: Seretide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Seretide	Drug	Combination of inhaled corticosteroids (250 microgr) and inhaled long-acting beta2-agonists (25 microgr)	Seretide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Eucapnic voluntary hyperventilation (EVH)		End of study
Exhaled Nitric Oxide		End of study

Secondary Outcomes

Measure	Description	Time Frame
Respiratory symptoms		End of study
Lung function		End of study

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Lund, MD	Respiratory and Allergy Research Unit, Department of Respiratory Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Respiratory and Allergy Research Unit, Department of Respiratory Medicine, Bispebjerg Hospital		Copenhagen		DK-2400 NV	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068297	Fluticasone-Salmeterol Drug Combination

Ancestor Terms

ID	Term
D000068299	Salmeterol Xinafoate
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided