AsthmaCLE004NCT00831428
Screening Scottish Swimmers for Asthma and Rhinitis
An observational study of Asthma and Rhinitis, run by Brian J Lipworth at 1 site in United Kingdom.
Trial summary
The Scottish National and District swimming teams will be screened for asthma and rhinitis using both mannitol challenge and sport-based exercise challenge. Read more about this study
- Who is it for?
- Ages 11 to 23 years
- How many people
- 97 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Jun 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The Scottish national and district swimming teams
Who may be able to join
- member of the Scottish national and district swimming team
- informed consent obtained
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The national swimming academy in Stirling
Stirling, Stirlingshire, FK9 4LA
About this study
Official title: 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.
- Being tested
- no intervention
- Keywords
- asthma, rhinitis, swimmers, mannitol
- Medical subject headings
- Asthma, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
this is a screening study, not an interventional study
| Study group | Role | What they receive |
|---|---|---|
| Scottish swimming team | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal Nitric Oxide
Measured: This test will be performed prior to entering the pool, and on exiting the pool
Secondary outcomes (5)
Mannitol Challenge
Measured: This test will be performed once on a district and once on a national squad training day
Sport-based Challenge
Measured: This test will be performed once on a district and once on a national squad training day
Nasal Nitric Oxide
Measured: This test will be performed prior to entering the pool, and on exiting the pool
Skin Prick Test
Measured: This test will be performed once on a district and once on a national squad training day
Mini Nasal Lavage
Measured: This test will be performed prior to entering the pool, and on exiting the pool
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brian J Lipworth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brian J Lipworth, University of Dundee
- Investigators
- Karine L Clearie, MBBS, MRCP, Principal investigator, Asthma and Allergy Research GroupBrian J Lipworth, MBchB, Study director, Asthma and Allergy Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831428
- Sponsor's protocol ID
- CLE004
- Acronym
- CLE004
- Status last verified
- Apr 2019
- First submitted
- 28 Jan 2009
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20214665
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Identify the Prevalence of Exercise- Induced Asthma and Rhinitis in Scottish Swimmers, Using Mannitol Challenge as a Screening Tool.
- ClinicalTrials.gov ID
- NCT00831428
- Acronym / sponsor ID
- CLE004 / CLE004
- Keywords
- asthma, rhinitis, swimmers, mannitol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Brian J LipworthUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Jan 2009 (estimated)
- Results
- Posted 23 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Scottish National and District swimming teams will be screened for asthma and rhinitis using both mannitol challenge and sport-based exercise challenge.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scottish swimming team | – | Other: no intervention |
Who may qualify
- Ages
- 11 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The Scottish national and district swimming teams
Key inclusion criteria (2 listed)
- member of the Scottish national and district swimming team
- informed consent obtained
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionthis is a screening study, not an interventional study | Other | Scottish swimming team |
Primary outcome
Tidal Nitric Oxide
Time frame: This test will be performed prior to entering the pool, and on exiting the pool
5 secondary outcomes
Mannitol Challenge
Time frame: 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
Nasal Nitric Oxide
Time frame: 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
Mini Nasal Lavage
Time frame: This test will be performed prior to entering the pool, and on exiting the pool
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20214665Clearie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine L Clearie, MBBS, MRCP principal investigator
Asthma and Allergy Research Group
Brian J Lipworth, MBchB study director
Asthma and Allergy Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Rhinitis, run by Brian J Lipworth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal Nitric Oxide (time frame: This test will be performed prior to entering the pool, and on exiting the pool). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00831428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.