CLE004: Screening Scottish Swimmers for Asthma and Rhinitis

• Sponsor: Brian J Lipworth (Other)
• Overall Status: Completed
• CT.gov ID: NCT00831428
• Collaborator: (none)
• Enrollment: 97
• Location: 1
• Duration (Months): 3.9
• Patients Per Site Per Month: 24.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma; Rhinitis	Other: no intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 97 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• 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.
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Scottish swimming team	Other: no intervention; this is a screening study, not an interventional study

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Mannitol Challenge [This test will be performed once on a district and once on a national squad training day]

2. Sport-based Challenge [This test will be performed once on a district and once on a national squad training day]

3. Nasal Nitric Oxide [This test will be performed prior to entering the pool, and on exiting the pool]

4. Skin Prick Test [This test will be performed once on a district and once on a national squad training day]

5. Mini Nasal Lavage [This test will be performed prior to entering the pool, and on exiting the pool]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 23 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The national swimming academy in Stirling	Stirling	Stirlingshire	United Kingdom	FK9 4LA

Sponsors and Collaborators

• Brian J Lipworth

Investigators

• Principal Investigator: Karine L Clearie, MBBS, MRCP, Asthma and Allergy Research Group
• Study Director: Brian J Lipworth, MBchB, Asthma and Allergy Research Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brian J Lipworth, Professor (Clinical) Airway allergy and COPD, University of Dundee
• ClinicalTrials.gov Identifier: NCT00831428
• Other Study ID Numbers: CLE004
• First Posted: Jan 29, 2009
• Last Update Posted: Apr 24, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Brian J Lipworth, Professor (Clinical) Airway allergy and COPD, University of Dundee: asthma; rhinitis; swimmers; mannitol
• Additional relevant MeSH terms: Rhinitis; Asthma

Study Results

Participant Flow

Recruitment Details	The scottish national and district teams were assessed during training weekends.
Pre-assignment Detail	All members of the squad were offered the opportunity to take part.

Arm/Group Title	Scottish Swimming Team
Arm/Group Description
Period Title: Overall Study
STARTED	97
COMPLETED	97
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Scottish Swimming Team
Arm/Group Description
Overall Participants	97
Age (Count of Participants)
<=18 years	97 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.2 (0.25)
Sex: Female, Male (Count of Participants)
Female	52 53.6%
Male	45 46.4%
Region of Enrollment (participants) [Number]
United Kingdom	97 100%

Outcome Measures

1. Secondary Outcome

Title	Mannitol Challenge
Time Frame	This test will be performed once on a district and once on a national squad training day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Secondary Outcome

Title	Sport-based Challenge
Time Frame	This test will be performed once on a district and once on a national squad training day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Primary Outcome

Title	Tidal Nitric Oxide
Time Frame	This test will be performed prior to entering the pool, and on exiting the pool

Outcome Measure Data

Analysis Population Description

Data from all participants was analysed

Arm/Group Title	Scottish Swimming Team
Arm/Group Description
Measure Participants	97
Geometric Mean (95% Confidence Interval) [ppb]	18.7

4. Secondary Outcome

Title	Nasal Nitric Oxide
Time Frame	This test will be performed prior to entering the pool, and on exiting the pool

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Skin Prick Test
Time Frame	This test will be performed once on a district and once on a national squad training day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Mini Nasal Lavage
Time Frame	This test will be performed prior to entering the pool, and on exiting the pool

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Scottish Swimming Team
Arm/Group Description
All Cause Mortality
	Scottish Swimming Team
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Scottish Swimming Team
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Scottish Swimming Team
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.