Trial Review

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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
ACTRN12605000155695
Ethics application status
Approved
Date submitted
15/08/2005
Date registered
15/08/2005
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Date results information initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Personal exposure to fungal allergens in asthma (NHMRC 253818)
Scientific title
Personal exposure to fungal allergens in asthma (NHMRC 253818)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 248 0
Condition category
Condition code
Respiratory 280 280 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No interventions. This is an observational study. We will observe:
Participant's exposure and allergic reaction to environmental fungi. No drugs or treatments will be administered
Intervention code [1] 186 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 329 0
The identity of fungal allergens to which participants are exposed and the associated allergic response will be investigated. One measurement will be made per participant.
Timepoint [1] 329 0
Secondary outcome [1] 735 0
Mechanisms of allergen release from fungal spores.
Timepoint [1] 735 0
These will be in-vitro measurements.

Eligibility
Key inclusion criteria
Symptoms of asthma consistent with location-specific asthma and allergies.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2004
Actual
30/12/2005
Date of last participant enrolment
Anticipated
Actual
30/12/2005
Date of last data collection
Anticipated
Actual
30/12/2005
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 335 0
Government body
Name [1] 335 0
NHMRC Project Grant
Country [1] 335 0
Australia
Primary sponsor type
Government body
Name
Totally NHMRC funded
Address
Country
Australia
Secondary sponsor category [1] 266 0
Government body
Name [1] 266 0
Totally NHMRC funded
Address [1] 266 0
Country [1] 266 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1277 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 1277 0
Ethics committee country [1] 1277 0
Australia
Date submitted for ethics approval [1] 1277 0
Approval date [1] 1277 0
01/06/2004
Ethics approval number [1] 1277 0
Ethics committee name [2] 1278 0
The Central Sydney Area Health Service Ethics Review Committee
Ethics committee address [2] 1278 0
Ethics committee country [2] 1278 0
Australia
Date submitted for ethics approval [2] 1278 0
Approval date [2] 1278 0
Ethics approval number [2] 1278 0
Ethics committee name [3] 1279 0
The Children's Hospital at Westmead Ethics Review Committee
Ethics committee address [3] 1279 0
Ethics committee country [3] 1279 0
Australia
Date submitted for ethics approval [3] 1279 0
Approval date [3] 1279 0
Ethics approval number [3] 1279 0

Summary
Brief summary
Trial website
Trial related presentations / publications
None known
Public notes

Contacts
Principal investigator
Name 35195 0
Address 35195 0
Country 35195 0
Phone 35195 0
Fax 35195 0
Email 35195 0
Contact person for public queries
Name 9375 0
Ms Wendy Taylor
Address 9375 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9375 0
Australia
Phone 9375 0
+61 2 95156578
Fax 9375 0
+61 2 95505865
Email 9375 0
wtaylor@woolcock.org.au
Contact person for scientific queries
Name 303 0
Dr Euan Tovey
Address 303 0
University of Sydney
Room 461
Blackburn Building D06
Camperdown NSW 2006
Country 303 0
Australia
Phone 303 0
+61 2 93512093
Fax 303 0
+61 2 93517451
Email 303 0
ert@med.usyd.edu.au

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.