Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12605000042640
Ethics application status
Approved
Date submitted
20/07/2005
Date registered
26/07/2005
Date last updated
26/07/2005
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Childhood Asthma Prevention Study
Query!
Scientific title
House dust mite allergen avoidance and omega 3 fatty acid supplementation to reduce the incidence of asthma in children with a family history.
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Asthma
108
0
Query!
Condition category
Condition code
Respiratory
127
127
0
0
Query!
Asthma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
House dust mite aviodance and omega-3 fatty acid supplementation.
Query!
Intervention code [1]
42
0
Prevention
Query!
Comparator / control treatment
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
159
0
Atopy (one or more skin tests greater than 2mm) using ATS criteria.
Query!
Assessment method [1]
159
0
Query!
Timepoint [1]
159
0
Query!
Primary outcome [2]
160
0
Symptom severity as defined the NAC (infrequent episodic, frequent episodic or persistent asthma) using ATS criteria.
Query!
Assessment method [2]
160
0
Query!
Timepoint [2]
160
0
Query!
Primary outcome [3]
161
0
Wheeze frequency using ATS criteria.
Query!
Assessment method [3]
161
0
Query!
Timepoint [3]
161
0
Query!
Primary outcome [4]
162
0
Possible asthma or current asthma using ATS criteria.
Query!
Assessment method [4]
162
0
Query!
Timepoint [4]
162
0
Query!
Secondary outcome [1]
355
0
Eczema
Query!
Assessment method [1]
355
0
Query!
Timepoint [1]
355
0
Query!
Secondary outcome [2]
356
0
Night cough
Query!
Assessment method [2]
356
0
Query!
Timepoint [2]
356
0
Query!
Secondary outcome [3]
357
0
Allergic symptoms
Query!
Assessment method [3]
357
0
Query!
Timepoint [3]
357
0
Query!
Eligibility
Key inclusion criteria
Family history of asthma ie families with a parent or child with current asthma, fluency in English, no cat as a family pet and a phone at home.
Query!
Minimum age
Not stated
Query!
Query!
Maximum age
Not stated
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
No exclusion criteria
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation was assigned using sequentially numbered sealed envelopes. The research nurses were responsible for recruiting participants and assigning participants to groups. The research team responsible for recruitment was blinded to the methods of randomization until recruitment was complete.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence was generated using Microsoft Excel random number generation facility.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Factorial
Query!
Other design features
Please note that the diet intervention was placebo controlled but the house dust mite intervention was not
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Date of first participant enrolment
Anticipated
1/04/1997
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
600
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
175
0
Government body
Query!
Name [1]
175
0
NHMRC
Query!
Address [1]
175
0
Query!
Country [1]
175
0
Australia
Query!
Funding source category [2]
176
0
Other
Query!
Name [2]
176
0
CRC for Asthma
Query!
Address [2]
176
0
Query!
Country [2]
176
0
Australia
Query!
Primary sponsor type
Government body
Query!
Name
Woolcock Institute of Medical Research
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
131
0
Hospital
Query!
Name [1]
131
0
CHW
Query!
Address [1]
131
0
Query!
Country [1]
131
0
Australia
Query!
Secondary sponsor category [2]
132
0
Hospital
Query!
Name [2]
132
0
Liverpool Hospital
Query!
Address [2]
132
0
Query!
Country [2]
132
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
942
0
University of Sydney
Query!
Ethics committee address [1]
942
0
Query!
Ethics committee country [1]
942
0
Australia
Query!
Date submitted for ethics approval [1]
942
0
Query!
Approval date [1]
942
0
Query!
Ethics approval number [1]
942
0
Query!
Ethics committee name [2]
943
0
the Children's Hospital at Westmead
Query!
Ethics committee address [2]
943
0
Query!
Ethics committee country [2]
943
0
Australia
Query!
Date submitted for ethics approval [2]
943
0
Query!
Approval date [2]
943
0
Query!
Ethics approval number [2]
943
0
Query!
Ethics committee name [3]
944
0
the Western and South Western Sydney Area Heath Services
Query!
Ethics committee address [3]
944
0
Query!
Ethics committee country [3]
944
0
Australia
Query!
Date submitted for ethics approval [3]
944
0
Query!
Approval date [3]
944
0
Query!
Ethics approval number [3]
944
0
Query!
Summary
Brief summary
In this study we are testing a public health intervention to reduce the incidence of childhood asthma. The two interventions that we are testing, that is housedust mite allergen avoidance and omega-3 fatty acid supplementation, are based on the strongest risk factors for asthma that have been identified in observational studies to date. This is the first trial in the world to test whether interventions directed at a potent causative factor (housedust mite allergens) or a protective factor (omega-3 fatty acids) can halt or reverse the increasing prevalence of childhood asthma. If either of these interventions is effective, we will have the potential for the very first time to significantly reduce the incidence of asthma in young children.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
36035
0
Query!
Address
36035
0
Query!
Country
36035
0
Query!
Phone
36035
0
Query!
Fax
36035
0
Query!
Email
36035
0
Query!
Contact person for public queries
Name
9231
0
Guy Marks
Query!
Address
9231
0
Woolcock Institute of Medical Research
University of Sydney
Level 6 Building F
88 Mallet St
Camperdown NSW 2050
Query!
Country
9231
0
Australia
Query!
Phone
9231
0
+61 2 95158631
Query!
Fax
9231
0
Query!
Email
9231
0
[email protected]
Query!
Contact person for scientific queries
Name
159
0
Seema Mihrshahi
Query!
Address
159
0
Children's Hospital Westmead
Locked Bag 4001
Westmead NSW 2145
Query!
Country
159
0
Australia
Query!
Phone
159
0
+61 2 98453061
Query!
Fax
159
0
+61 2 98453082
Query!
Email
159
0
[email protected]
Query!
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
Source
Title
Year of Publication
DOI
Embase
Childhood fish oil supplementation modifies associations between traffic related air pollution and allergic sensitisation.
2018
https://dx.doi.org/10.1186/s12940-018-0370-5
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF