- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00841425
Airway Responsiveness and Inflammation in Adolescent Elite Swimmers: a 3-Year Prospective Follow-up Study
February 23, 2009 updated by: Bispebjerg Hospital
Previously the investigators have found that adolescent elite swimmers, who have been involved in competitive swimming for only a few years, have not developed respiratory symptoms, signs of airway inflammation or airway hyperresponsiveness exept for a slight increase in airway responsiveness to eucapnic voluntary hyperpnea.
In the current study, the investigators will be doing a 3-year follow-up study on the swimmers studied previously.
Study Overview
Status
Unknown
Conditions
Detailed Description
Even though studies suggest that elite sport can cause AHR and airway inflammation, more studies are needed to elucidate how and when AHR and airway inflammation develop; and there is a lack of follow-up studies.
The present study will give us a chance to do a follow-up study to register changes in AHR and airway inflammation in athletes without any significant airway changes at baseline.
Study Type
Observational
Enrollment (Anticipated)
33
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark, 2400
- Recruiting
- Respiratory and Allergy Research Unit, Department of Respiratory Medicine L, Bispebjerg Hospital
-
Contact:
- Lars Pedersen, MD PhD
- Phone Number: (+45) 35 31 30 69
- Email: lars.pedersen@dadlnet.dk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 19 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants were all elite swimmers and part of the Danish National Swimming Association's talent program for young swimmers at the baseline study.
Description
Inclusion Criteria:
- Age 15-19 years
- Part of the Danish National Swimming Association's talent program for young swimmers at the baseline study
- Informed consent
Exclusion Criteria:
- Upper respiratory tract infection in the previous 4 weeks (visits will be postponed)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Swimmers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Airway responsiveness to eucapnic voluntary hyperpnea and methacholine
Time Frame: Three years
|
Three years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Airway inflammation
Time Frame: Three years
|
Three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lars Pedersen, MD PhD, Respiratory and Allergy Research Unit, Bispebjerg Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (ANTICIPATED)
June 1, 2009
Study Completion (ANTICIPATED)
June 1, 2010
Study Registration Dates
First Submitted
February 10, 2009
First Submitted That Met QC Criteria
February 10, 2009
First Posted (ESTIMATE)
February 11, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
February 24, 2009
Last Update Submitted That Met QC Criteria
February 23, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-B-2009-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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