Exercise Induced Asthma and Airway Reactivity in Athletes | NCT00798564

Studies
Exercise Induced Asthma and Airway Reactivity in Athletes

NCT00798564

Sponsor

Skane University Hospital

Status

Completed

Last Update Posted

Mar 18, 2021Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Respiratory Function Tests

Interventions

Not provided

Countries

Not provided

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

Status Module

Record Verification Date

Mar 2021

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

Mar 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Nov 25, 2008

First Submission Date that Met QC Criteria

Nov 25, 2008

First Posted Date

Nov 26, 2008Estimated

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

Mar 15, 2021

Last Update Posted Date

Mar 18, 2021Actual

Name	Class
Swedish Heart Lung Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The overall aim is to explore pathophysiological factors related to airway hyperresponsiveness to direct and indirect provocation stimuli in athletes with different sport activities, with special focus on epithelial reaction linked to CC16 and to eicosanoid related inflammatory response. The investigators also wish to compare indirect testing done as hyper osmotic challenge with Mannitol compared to a defined sport specific exercise challenge.

Detailed Description

By non-invasive tools the investigators wish to characterize type of airway reaction to various provocative stimuli in athletes doing two different sort activities, Tennis or swimming. As controls are being used sedentary age-matched controls from the same region, exposed to the same school environment. Thus we wish to:

explore the prevalence of positive mannitol reactivity among swimmers and tennis player and how this relates to symptoms, disease history and to a sport specific exercise provocation test.
compare the results from sport specific testing with a standardized eucapnic hyperventilation test (EHV)
compare the overall reactivity to mannitol or EHV among swimmers and tennis players compared to aged matched controls.
explore the role by CC16 in airway reactivity to different provocative stimuli and to see whether there is a difference between different sport activities, different test protocols and between athletes and controls.
explore evidence of eicosanoid related inflammatory reaction in athletes and controls in relation to different provocative stimuli

The study population consists of 100 elite swimmers, 100 elite tennis players and 100 non-elite, eged matched controls. In the latter group, 30 are aged matched non-atopic non-asthmatic controls.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects aged 16-19 from Skåne.
All should approve attendance in the study by signing an informed consent. Igf they are aged under 18, parents should also sign.
Three groups are included
Elite aspiring swimmers with an average training intensity of at least hours per week the last year.

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

100 elite swimmers 100 elite tennis players 100 aged matched non-atletic subjects, 30 aged-matcked healthy non-atopic controls

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leif H Bjermer, MD, PhD	Lund University	Principal Investigator

Locations

Not provided