Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000156684
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
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fungal allergy and domestic exposure to fungi in cystic fibrosis (Australian Cystic Fibrosis Research Trust 2004/052)
Scientific title
Fungal exposure and fungal-specific lgE in subjects with cystic fibrosis (Australian Cystic Fibrosis Research Trust 2004/052)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Bronchopulmonary Aspergillosis
 249 0
Cystic Fibrosis 250 0
Condition category
Condition code
Human Genetics and Inherited Disorders 281 281 0 0
Cystic fibrosis
Blood 282 282 0 0
Other inflammatory or immune system disorders

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] 187 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 330 0
The identity of fungal allergens to which participants are exposed and the associated allergic response will be investigated.
Timepoint [1] 330 0
One measurement will be made per participant over 24 hours.
Secondary outcome [1] 736 0
Mechanisms of allergen release from fungal spores.
Timepoint [1] 736 0
These will be in-vitro measurements.

Eligibility
Key inclusion criteria
Fungal allergic cystic fibrosis patients. CF patients with ABPA
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
1/03/2004
Actual
1/03/2004
Date of last participant enrolment
Anticipated
Actual
31/12/2004
Date of last data collection
Anticipated
Actual
31/12/2004
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 336 0
Charities/Societies/Foundations
Name [1] 336 0
Australian Cystic Fibrosis Research Trust
Country [1] 336 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Cystic Fibrosis Research Trust 2004/052
Address
Country
Australia
Secondary sponsor category [1] 267 0
Other
Name [1] 267 0
N/A
Address [1] 267 0
Country [1] 267 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1280 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 1280 0
Ethics committee country [1] 1280 0
Australia
Date submitted for ethics approval [1] 1280 0
Approval date [1] 1280 0
01/03/2004
Ethics approval number [1] 1280 0
Ethics committee name [2] 1281 0
The Central Sydney Area Health Service Ethics Review Committee
Ethics committee address [2] 1281 0
Ethics committee country [2] 1281 0
Australia
Date submitted for ethics approval [2] 1281 0
Approval date [2] 1281 0
Ethics approval number [2] 1281 0
Ethics committee name [3] 1282 0
The Children's Hospital at Westmead Ethics Review Committee
Ethics committee address [3] 1282 0
Ethics committee country [3] 1282 0
Australia
Date submitted for ethics approval [3] 1282 0
Approval date [3] 1282 0
Ethics approval number [3] 1282 0

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

Contacts
Principal investigator
Name 35884 0
Address 35884 0
Country 35884 0
Phone 35884 0
Fax 35884 0
Email 35884 0
Contact person for public queries
Name 9376 0
Ms Wendy Taylor
Address 9376 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9376 0
Australia
Phone 9376 0
+61 2 95156578
Fax 9376 0
+61 2 95505865
Email 9376 0
wtaylor@woolcock.org.au
Contact person for scientific queries
Name 304 0
Dr Euan Tovey
Address 304 0
University of Sydney
Room 461
Blackburn Building D06
Camperdown NSW 2006
Country 304 0
Australia
Phone 304 0
+61 2 93512093
Fax 304 0
+61 2 93517451
Email 304 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.