Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000157673
Ethics application status
Approved
Date submitted
15/08/2005
Date registered
15/08/2005
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mite and endotoxin exposure in the beds of children with asthma (NHMRC 352427)
Scientific title
Exploration of exposures associated with bedding that are risks for childhood allergy and asthma symptoms (NHMRC 352427)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma
 251 0
Allergy 252 0
Condition category
Condition code
Respiratory 283 283 0 0
Asthma
Inflammatory and Immune System 284 284 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
Feather and non-feather bedding.
We will observe:
Participant's exposure and allergic reaction to feather and other particles arising from these types of bedding. No drugs or treatments will be administered.
Intervention code [1] 188 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 331 0
To see if a difference in allergen and endotoxin exposure arising from each type of bedding will affect asthma symptoms.
Timepoint [1] 331 0
One measurement will be made per participant over 4 days.
Secondary outcome [1] 737 0
Characterize the types of inhaled particles from feather bedding.
Timepoint [1] 737 0

Eligibility
Key inclusion criteria
Asthmatic children
Minimum age
Not stated
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
No exclusion criteria

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2005
Actual
1/01/2005
Date of last participant enrolment
Anticipated
Actual
31/12/2005
Date of last data collection
Anticipated
Actual
31/12/2005
Sample size
Target
300
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 337 0
Government body
Name [1] 337 0
NHMRC
Country [1] 337 0
Australia
Primary sponsor type
Government body
Name
NHMRC 352427
Address
Country
Australia
Secondary sponsor category [1] 268 0
None
Name [1] 268 0
N/A
Address [1] 268 0
Country [1] 268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1283 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 1283 0
Ethics committee country [1] 1283 0
Australia
Date submitted for ethics approval [1] 1283 0
30/06/2004
Approval date [1] 1283 0
30/06/2004
Ethics approval number [1] 1283 0
Ethics committee name [2] 1284 0
The Children's Hospital at Westmead Ethics Review Committee
Ethics committee address [2] 1284 0
Ethics committee country [2] 1284 0
Australia
Date submitted for ethics approval [2] 1284 0
Approval date [2] 1284 0
Ethics approval number [2] 1284 0
Ethics committee name [3] 1285 0
The Australian National University Human Research Ethics Committee
Ethics committee address [3] 1285 0
Ethics committee country [3] 1285 0
Australia
Date submitted for ethics approval [3] 1285 0
Approval date [3] 1285 0
Ethics approval number [3] 1285 0

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

Contacts
Principal investigator
Name 35498 0
Address 35498 0
Country 35498 0
Phone 35498 0
Fax 35498 0
Email 35498 0
Contact person for public queries
Name 9377 0
Ms Wendy Taylor
Address 9377 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9377 0
Australia
Phone 9377 0
+61 2 95156578
Fax 9377 0
+61 2 95505865
Email 9377 0
wtaylor@woolcock.org.au
Contact person for scientific queries
Name 305 0
Dr Euan Tovey
Address 305 0
University of Sydney
Room 461
Blackburn Building D06
Camperdown NSW 2006
Country 305 0
Australia
Phone 305 0
+61 2 93512093
Fax 305 0
+61 2 93517451
Email 305 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.