Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000343606
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
9/09/2005
Date last updated
9/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nitric Oxide Laboratory Animal Allergy Study
Scientific title
Use of serial exhaled nitric oxide measurements in detecting airways inflammation in subjects exposed to laboratory animals during a typical working week
Universal Trial Number (UTN)
Trial acronym
NOLAA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laboratory Animal Allergy 436 0
Asthma 437 0
Condition category
Condition code
Inflammatory and Immune System 508 508 0 0
Allergies
Respiratory 509 509 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None
Intervention code [1] 394 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 579 0
To assess whether exhaled nitric oxide levels are elevated in laboratory workers with laboratory animal allergy
Timepoint [1] 579 0
Secondary outcome [1] 1235 0
To assess whether exhaled nitric oxide levels in exposed laboratory workers increase during the working week and whether this increase is a sensitive marker of early airways disease in laboratory animal allergy.
Timepoint [1] 1235 0

Eligibility
Key inclusion criteria
Subjects working with laboratory animals >2 days per week and for a duration of at least 6 months.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Oral or inhaled steroids within the last 6 weeks.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 181 0
New Zealand
State/province [1] 181 0

Funding & Sponsors
Funding source category [1] 570 0
Commercial sector/Industry
Name [1] 570 0
Accident and Compensation Corporation New Zealand
Country [1] 570 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
ACC New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 462 0
University
Name [1] 462 0
University of Otago
Address [1] 462 0
Country [1] 462 0
New Zealand

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35386 0
Address 35386 0
Country 35386 0
Phone 35386 0
Fax 35386 0
Email 35386 0
Contact person for public queries
Name 9583 0
Dr Richard Hewitt
Address 9583 0
Otago Respiratory Research Group
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
Country 9583 0
New Zealand
Phone 9583 0
+64 3 4740999 (Ext. 8785)
Fax 9583 0
Email 9583 0
richard.hewitt@stonebow.otago.ac.nz
Contact person for scientific queries
Name 511 0
Professor D Robin Taylor
Address 511 0
Otago Respiratory Research Group
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
Country 511 0
New Zealand
Phone 511 0
+64 3 4740999 (Ext. 8785)
Fax 511 0
Email 511 0
robin.taylor@stonebow.otago.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.