Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000251527
Ethics application status
Approved
Date submitted
21/06/2006
Date registered
23/06/2006
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Symptoms, allergy and personal exposure to Plane Tree bioaerosols
Scientific title
Does exposure to Plane Tree bioaerosols lead to an increase in symptoms of respiratory allergy?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory allergies 1230 0
Condition category
Condition code
Respiratory 1313 1313 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a preliminary, prospective study to investigate the exposure of Sydney residents to bioaerosols associated with the Plane Tree (Platanus x hybrida).No drugs or teatments will be used. We will be observing symptoms of respiratory allergies, including rhinitis and asthma. Subjective symptom scores will be recorded, as well as self-administered peak flow tests. Participants will be observed for 3 months.
Intervention code [1] 1155 0
Diagnosis / Prognosis
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 1796 0
Determination of the extent to which Plane Tree bioaerosols contribute to the respiratory symptoms of allergic Sydney residents.
Timepoint [1] 1796 0
Initially this will be measured over the 2006-2007 pollen season (August to November). The project is set to run from July 2006 to July 2007.
Secondary outcome [1] 3150 0
Nil
Timepoint [1] 3150 0

Eligibility
Key inclusion criteria
Participants must be allergic to Plane Tree pollen. Inclusion Criteria: Atopic to Platanus sp. by skin prick test.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not atopic to Platanus sp. by skin prick test.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Estimate - details not know
Date of first participant enrolment
Anticipated
30/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1439 0
Government body
Name [1] 1439 0
Environmental Trust
Country [1] 1439 0
Primary sponsor type
Government body
Name
Environmental Trust
Address
Country
Australia
Secondary sponsor category [1] 1273 0
Government body
Name [1] 1273 0
Environmental Trust
Address [1] 1273 0
Country [1] 1273 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2814 0
University of Sydney HREC
Ethics committee address [1] 2814 0
Ethics committee country [1] 2814 0
Australia
Date submitted for ethics approval [1] 2814 0
Approval date [1] 2814 0
05/06/2006
Ethics approval number [1] 2814 0
06-2006/3/9133

Summary
Brief summary
We will determine the contribution of Plane Trees to the respiratory symptoms of inner-Sydney residents. We will measure the allergic symptoms of groups of patients over the Spring and Summer, while sampling air at 2 city locations and also specific locations related to exacerbations of symptoms (attacks) in individuals. The results of this study will help people manage their allergies, and provide information for policy-makers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35640 0
Address 35640 0
Country 35640 0
Phone 35640 0
Fax 35640 0
Email 35640 0
Contact person for public queries
Name 10344 0
Sarah Newton-John
Address 10344 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 10344 0
Australia
Phone 10344 0
+61 2 95156578
Fax 10344 0
+61 2 95505865
Email 10344 0
[email protected]
Contact person for scientific queries
Name 1272 0
Mr Jason Sercombe
Address 1272 0
University of Sydney
Blackburn Building D06
Room 461
Camperdown NSW 2006
Country 1272 0
Australia
Phone 1272 0
+61 2 93512169
Fax 1272 0
+61 2 93517451
Email 1272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.