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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014