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Screening Scottish Swimmers for Asthma and Rhinitis (CLE004)

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ClinicalTrials.gov Identifier: NCT00831428
Recruitment Status : Completed
First Posted : January 29, 2009
Results First Posted : September 23, 2011
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Cross-Sectional
Conditions Asthma
Rhinitis
Intervention Other: no intervention
Enrollment 97
Recruitment Details The scottish national and district teams were assessed during training weekends.
Pre-assignment Details All members of the squad were offered the opportunity to take part.
Arm/Group Title Scottish Swimming Team
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 97
Completed 97
Not Completed 0
Arm/Group Title Scottish Swimming Team
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants
<=18 years
97
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants
15.2  (0.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants
Female
52
  53.6%
Male
45
  46.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 97 participants
97
1.Primary Outcome
Title Tidal Nitric Oxide
Hide Description [Not Specified]
Time Frame This test will be performed prior to entering the pool, and on exiting the pool
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from all participants was analysed
Arm/Group Title Scottish Swimming Team
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 97
Geometric Mean (95% Confidence Interval)
Unit of Measure: ppb
18.7
(15.9 to 22.0)
2.Secondary Outcome
Title Mannitol Challenge
Hide Description [Not Specified]
Time Frame This test will be performed once on a district and once on a national squad training day
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Sport-based Challenge
Hide Description [Not Specified]
Time Frame This test will be performed once on a district and once on a national squad training day
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Nasal Nitric Oxide
Hide Description [Not Specified]
Time Frame This test will be performed prior to entering the pool, and on exiting the pool
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Skin Prick Test
Hide Description [Not Specified]
Time Frame This test will be performed once on a district and once on a national squad training day
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Mini Nasal Lavage
Hide Description [Not Specified]
Time Frame This test will be performed prior to entering the pool, and on exiting the pool
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Scottish Swimming Team
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Scottish Swimming Team
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Scottish Swimming Team
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Scottish Swimming Team
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Karine Clearie
Organization: University of Dundee
Phone: 01382 496440
Responsible Party: Brian J Lipworth, University of Dundee
ClinicalTrials.gov Identifier: NCT00831428     History of Changes
Other Study ID Numbers: CLE004
First Submitted: January 28, 2009
First Posted: January 29, 2009
Results First Submitted: August 11, 2011
Results First Posted: September 23, 2011
Last Update Posted: April 10, 2018