Airway Responsiveness and Inflammation in Adolescent Elite Swimmers: a 3-Year Prospective Follow-up Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Bispebjerg Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00841425
First received: February 10, 2009
Last updated: February 23, 2009
Last verified: February 2009
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Airway Responsiveness and Inflammation in Adolescent Elite Swimmers: a 3-Year Prospective Follow-up Study

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Airway responsiveness to eucapnic voluntary hyperpnea and methacholine [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Airway inflammation [ Time Frame: Three years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood (serum, whole blood) Exhaled breath condensate Induced sputum


Estimated Enrollment: 33
Study Start Date: February 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

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.

  Eligibility

Ages Eligible for Study:   15 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841425

Contacts
Contact: Lars Pedersen, MD PhD (+45) 35 31 30 69 lars.pedersen@dadlnet.dk

Locations
Denmark
Respiratory and Allergy Research Unit, Department of Respiratory Medicine L, Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Lars Pedersen, MD PhD    (+45) 35 31 30 69    lars.pedersen@dadlnet.dk   
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Lars Pedersen, MD PhD Respiratory and Allergy Research Unit, Bispebjerg Hospital
  More Information

Publications:
Responsible Party: Lars Pedersen (MD PhD), Respiratory and Allergy Research Unit, Bispebjerg Hospital, Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT00841425     History of Changes
Other Study ID Numbers: H-B-2009-012
Study First Received: February 10, 2009
Last Updated: February 23, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014