Trial registered on ANZCTR


Trial ID
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
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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 108 0
Condition category
Condition code
Respiratory 127 127 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
House dust mite aviodance and omega-3 fatty acid supplementation.
Intervention code [1] 42 0
Prevention
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 159 0
Atopy (one or more skin tests greater than 2mm) using ATS criteria.
Timepoint [1] 159 0
Primary outcome [2] 160 0
Symptom severity as defined the NAC (infrequent episodic, frequent episodic or persistent asthma) using ATS criteria.
Timepoint [2] 160 0
Primary outcome [3] 161 0
Wheeze frequency using ATS criteria.
Timepoint [3] 161 0
Primary outcome [4] 162 0
Possible asthma or current asthma using ATS criteria.
Timepoint [4] 162 0
Secondary outcome [1] 355 0
Eczema
Timepoint [1] 355 0
Secondary outcome [2] 356 0
Night cough
Timepoint [2] 356 0
Secondary outcome [3] 357 0
Allergic symptoms
Timepoint [3] 357 0

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.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Please note that the diet intervention was placebo controlled but the house dust mite intervention was not
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 175 0
Government body
Name [1] 175 0
NHMRC
Address [1] 175 0
Country [1] 175 0
Australia
Funding source category [2] 176 0
Other
Name [2] 176 0
CRC for Asthma
Address [2] 176 0
Country [2] 176 0
Australia
Primary sponsor type
Government body
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 131 0
Hospital
Name [1] 131 0
CHW
Address [1] 131 0
Country [1] 131 0
Australia
Secondary sponsor category [2] 132 0
Hospital
Name [2] 132 0
Liverpool Hospital
Address [2] 132 0
Country [2] 132 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 942 0
University of Sydney
Ethics committee address [1] 942 0
Ethics committee country [1] 942 0
Australia
Date submitted for ethics approval [1] 942 0
Approval date [1] 942 0
Ethics approval number [1] 942 0
Ethics committee name [2] 943 0
the Children's Hospital at Westmead
Ethics committee address [2] 943 0
Ethics committee country [2] 943 0
Australia
Date submitted for ethics approval [2] 943 0
Approval date [2] 943 0
Ethics approval number [2] 943 0
Ethics committee name [3] 944 0
the Western and South Western Sydney Area Heath Services
Ethics committee address [3] 944 0
Ethics committee country [3] 944 0
Australia
Date submitted for ethics approval [3] 944 0
Approval date [3] 944 0
Ethics approval number [3] 944 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36035 0
Address 36035 0
Country 36035 0
Phone 36035 0
Fax 36035 0
Email 36035 0
Contact person for public queries
Name 9231 0
Guy Marks
Address 9231 0
Woolcock Institute of Medical Research
University of Sydney
Level 6 Building F
88 Mallet St
Camperdown NSW 2050
Country 9231 0
Australia
Phone 9231 0
+61 2 95158631
Fax 9231 0
Email 9231 0
G.Marks@unsw.edu.au
Contact person for scientific queries
Name 159 0
Seema Mihrshahi
Address 159 0
Children's Hospital Westmead
Locked Bag 4001
Westmead NSW 2145
Country 159 0
Australia
Phone 159 0
+61 2 98453061
Fax 159 0
+61 2 98453082
Email 159 0
seemam@chw.edu.au