Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
[email protected]
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
[email protected]

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.