- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00831428
Screening Scottish Swimmers for Asthma and Rhinitis (CLE004)
April 10, 2019 updated by: Brian J Lipworth
A Pilot Study to Identify the Prevalence of Exercise- Induced Asthma and Rhinitis in Scottish Swimmers, Using Mannitol Challenge as a Screening Tool.
The Scottish National and District swimming teams will be screened for asthma and rhinitis using both mannitol challenge and sport-based exercise challenge.
Study Overview
Study Type
Observational
Enrollment (Actual)
97
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
-
-
Stirlingshire
-
Stirling, Stirlingshire, United Kingdom, FK9 4LA
- The national swimming academy in Stirling
-
-
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
11 years to 23 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The Scottish national and district swimming teams
Description
Inclusion Criteria:
- member of the Scottish national and district swimming team
- informed consent obtained
Exclusion Criteria:
- 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.
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 |
Intervention / Treatment |
---|---|
Scottish swimming team
|
this is a screening study, not an interventional study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tidal Nitric Oxide
Time Frame: This test will be performed prior to entering the pool, and on exiting the pool
|
This test will be performed prior to entering the pool, and on exiting the pool
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mannitol Challenge
Time Frame: This test will be performed once on a district and once on a national squad training day
|
This test will be performed once on a district and once on a national squad training day
|
Sport-based Challenge
Time Frame: This test will be performed once on a district and once on a national squad training day
|
This test will be performed once on a district and once on a national squad training day
|
Nasal Nitric Oxide
Time Frame: This test will be performed prior to entering the pool, and on exiting the pool
|
This test will be performed prior to entering the pool, and on exiting the pool
|
Skin Prick Test
Time Frame: This test will be performed once on a district and once on a national squad training day
|
This test will be performed once on a district and once on a national squad training day
|
Mini Nasal Lavage
Time Frame: This test will be performed prior to entering the pool, and on exiting the pool
|
This test will be performed prior to entering the pool, and on exiting the pool
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karine L Clearie, MBBS, MRCP, Asthma and Allergy Research Group
- Study Director: Brian J Lipworth, MBchB, Asthma and Allergy Research Group
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 (Actual)
May 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
January 28, 2009
First Submitted That Met QC Criteria
January 28, 2009
First Posted (Estimate)
January 29, 2009
Study Record Updates
Last Update Posted (Actual)
April 24, 2019
Last Update Submitted That Met QC Criteria
April 10, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLE004
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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