NCT00841425

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 24, 2009

Status Verified

February 1, 2009

Enrollment Period

4 months

First QC Date

February 10, 2009

Last Update Submit

February 23, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • Airway responsiveness to eucapnic voluntary hyperpnea and methacholine

    Three years

Secondary Outcomes (1)

  • Airway inflammation

    Three years

Study Arms (1)

Swimmers

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Age 15-19 years
  • Part of the Danish National Swimming Association's talent program for young swimmers at the baseline study
  • Informed consent

You may not qualify if:

  • Upper respiratory tract infection in the previous 4 weeks (visits will be postponed)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory and Allergy Research Unit, Department of Respiratory Medicine L, Bispebjerg Hospital

Copenhagen, 2400, Denmark

RECRUITING

Related Publications (1)

  • Pedersen L, Lund TK, Barnes PJ, Kharitonov SA, Backer V. Airway responsiveness and inflammation in adolescent elite swimmers. J Allergy Clin Immunol. 2008 Aug;122(2):322-7, 327.e1. doi: 10.1016/j.jaci.2008.04.041. Epub 2008 Jun 12.

    PMID: 18554704BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Lars Pedersen, MD PhD

    Respiratory and Allergy Research Unit, Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Pedersen, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

February 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2010

Last Updated

February 24, 2009

Record last verified: 2009-02

Locations