NCT00831428

Brief Summary

The Scottish National and District swimming teams will be screened for asthma and rhinitis using both mannitol challenge and sport-based exercise challenge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

September 23, 2011

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

January 28, 2009

Results QC Date

August 11, 2011

Last Update Submit

April 10, 2019

Conditions

Keywords

asthmarhinitisswimmersmannitol

Outcome Measures

Primary Outcomes (1)

  • Tidal Nitric Oxide

    This test will be performed prior to entering the pool, and on exiting the pool

Secondary Outcomes (5)

  • Mannitol Challenge

    This test will be performed once on a district and once on a national squad training day

  • Sport-based Challenge

    This test will be performed once on a district and once on a national squad training day

  • Nasal Nitric Oxide

    This test will be performed prior to entering the pool, and on exiting the pool

  • Skin Prick Test

    This test will be performed once on a district and once on a national squad training day

  • Mini Nasal Lavage

    This test will be performed prior to entering the pool, and on exiting the pool

Study Arms (1)

Scottish swimming team

Other: no intervention

Interventions

this is a screening study, not an interventional study

Scottish swimming team

Eligibility Criteria

Age11 Years - 23 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The Scottish national and district swimming teams

You may qualify if:

  • member of the Scottish national and district swimming team
  • informed consent obtained

You may not qualify if:

  • pregnant, lactating or planning to become pregnant
  • concomitant use of medicines (prescribed, over-the-counter or herbal) that may interfere with the trial.
  • any clinically significant medical condition, as deemed by the clinical investigators, which may endanger the health of the participant or jeopardise the protocol.
  • inability to comply with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The national swimming academy in Stirling

Stirling, Stirlingshire, FK9 4LA, United Kingdom

Location

Related Publications (1)

  • Clearie KL, Williamson PA, Vaidyanathan S, Short P, Goudie A, Burns P, Hopkinson P, Meldrum K, Howaniec L, Lipworth BJ. Disconnect between standardized field-based testing and mannitol challenge in Scottish elite swimmers. Clin Exp Allergy. 2010 May;40(5):731-7. doi: 10.1111/j.1365-2222.2010.03461.x. Epub 2010 Mar 1.

MeSH Terms

Conditions

AsthmaRhinitis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr Karine Clearie
Organization
University of Dundee

Study Officials

  • Karine L Clearie, MBBS, MRCP

    Asthma and Allergy Research Group

    PRINCIPAL INVESTIGATOR
  • Brian J Lipworth, MBchB

    Asthma and Allergy Research Group

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor (Clinical) Airway allergy and COPD

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 29, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2009

Study Completion

June 1, 2009

Last Updated

April 24, 2019

Results First Posted

September 23, 2011

Record last verified: 2019-04

Locations