Screening Scottish Swimmers for Asthma and Rhinitis (CLE004)

This study has been completed.
Sponsor:
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00831428
First received: January 28, 2009
Last updated: August 11, 2011
Last verified: May 2009
Results First Received: August 11, 2011  
Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Conditions: Asthma
Rhinitis
Intervention: Other: no intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The scottish national and district teams were assessed during training weekends.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All members of the squad were offered the opportunity to take part.

Reporting Groups
  Description
Scottish Swimming Team No text entered.

Participant Flow:   Overall Study
    Scottish Swimming Team  
STARTED     97  
COMPLETED     97  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Scottish Swimming Team No text entered.

Baseline Measures
    Scottish Swimming Team  
Number of Participants  
[units: participants]
  97  
Age  
[units: participants]
 
<=18 years     97  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  15.2  ± 0.25  
Gender  
[units: participants]
 
Female     52  
Male     45  
Region of Enrollment  
[units: participants]
 
United Kingdom     97  



  Outcome Measures

1.  Primary:   Tidal Nitric Oxide   [ Time Frame: This test will be performed prior to entering the pool, and on exiting the pool ]

2.  Secondary:   Mannitol Challenge   [ Time Frame: This test will be performed once on a district and once on a national squad training day ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Sport-based Challenge   [ Time Frame: This test will be performed once on a district and once on a national squad training day ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Nasal Nitric Oxide   [ Time Frame: This test will be performed prior to entering the pool, and on exiting the pool ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Skin Prick Test   [ Time Frame: This test will be performed once on a district and once on a national squad training day ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Mini Nasal Lavage   [ Time Frame: This test will be performed prior to entering the pool, and on exiting the pool ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr Karine Clearie
Organization: University of Dundee
phone: 01382 496440
e-mail: k.clearie@dundee.ac.uk


No publications provided


Responsible Party: Dr Karine Clearie, Asthma and Allergy Research Group
ClinicalTrials.gov Identifier: NCT00831428     History of Changes
Other Study ID Numbers: CLE004
Study First Received: January 28, 2009
Results First Received: August 11, 2011
Last Updated: August 11, 2011
Health Authority: United Kingdom: Research Ethics Committee