Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000205437
Ethics application status
Approved
Date submitted
10/04/2007
Date registered
13/04/2007
Date last updated
30/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to test the practicality and acceptability of environmental allergen reduction interventions in the home environment of children with asthma
Scientific title
A pilot study to test the practicality and acceptability of environmental allergen reduction interventions in the home environment of children with asthma
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 1730 0
Condition category
Condition code
Respiratory 1821 1821 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Allergen avoidance measures within the home environment which are tailored to the child's skin prick tests, such as allergen occlusive duvet, pillow, mattress, and bed base coverings; laundering with an acaricide; drying laundry in sunlight; pest control measures and extermination; Highly Efficient Particulate Arrestance (HEPA) filter in bedroom air filter and in vacuum cleaner; smoke-free indoor environment; mould eradication and avoidance. The duration of all interventions in both active and control groups is 6 months.
Intervention code [1] 1694 0
Treatment: Other
Comparator / control treatment
Control group will get placebo equivalents of the active treatments. The duration of all interventions in both active and control groups is 6 months.
Control group
Placebo

Outcomes
Primary outcome [1] 2552 0
Acceptability and practicality of conducting the study (assessed at the end of the pilot).
Timepoint [1] 2552 0
Assessed at the end of the 6 month study and will be derived from data collected throughout the whole of the 6 month time.
Primary outcome [2] 2553 0
Total days with asthma symptoms
Timepoint [2] 2553 0
Recorded in a daily diary for two week periods every two months; and assessed at the end of the 6 month study and will be derived from data collected throughout the whole of the 6 month time.
Secondary outcome [1] 4398 0
Peak Expiratory Flow Rate (PEFR).
Timepoint [1] 4398 0
Morning and evening every day for one fortnight every 2 months. .
Secondary outcome [2] 4399 0
Juniper's Paediatric Asthma Quality of Life Questionnaire
Timepoint [2] 4399 0
Administered every 2 months for 6 months.
Secondary outcome [3] 4400 0
Allergen levels in bed and floor dust samples
Timepoint [3] 4400 0
Taken at the end of the study (at 6 months) compared to baseline sample levels.

Eligibility
Key inclusion criteria
Physician diagnosed asthma, parents have low income, child spends at least 5 nights of the week in one home, and who had at least one hospital admission or two unscheduled visits to the doctor, or actue medical service due to asthma in the past six months (but subjects will be delayed from entering the trial until at least 3 weeks has elapsed since their last exacerbation).
Minimum age
5 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
On oral corticosteroids, other signifcant respiratory disease, andy serious chronic illness, not planning to stay in the same home for next 6 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Single-blind study (subjects will be blind), there will be no concealment procedure for the researchers who will not be blind. Subjects will be screened and assigned to the appropriate module depending on their skin prick tests and the presence of allergens in their home. Subjects will be randomized to either the active or the control version of that module.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random number
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The subjects will be blind, the researchers will know of the allocation assignment. This is a pilot study of only 10 subjects
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 510 0
New Zealand
State/province [1] 510 0

Funding & Sponsors
Funding source category [1] 1973 0
Government body
Name [1] 1973 0
Health Research Council of New Zealand
Country [1] 1973 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
Level 3, 110 Stanley Street, Auckland, 1010
Country
New Zealand
Secondary sponsor category [1] 1786 0
University
Name [1] 1786 0
University of Otago
Address [1] 1786 0
PO Box 7343
Newtown
Wellington 6242
Country [1] 1786 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3668 0
Central Regional Ethics Committee
Ethics committee address [1] 3668 0
PO Box 5013
Wellington 6145
Ethics committee country [1] 3668 0
New Zealand
Date submitted for ethics approval [1] 3668 0
Approval date [1] 3668 0
16/05/2007
Ethics approval number [1] 3668 0

Summary
Brief summary
This is a small simple pilot study to identify any practical and acceptability issues with conducting this kind of trial which aims to replicate the trial design of Morgan et al published in the New England Journal of medicine in 2004, which found a significant reduction in asthma symptoms days by reducing allergen levels in the home enviromnet through allergen avoidance measures that were tailored to the child's skin prick test status. In New Zealand we have a somewhat different prevalence of the kinds of allergens found in the United States and we have a much higher prevalence of childhood asthma, hence it is important to pilot the Morgan study design in the New Zealand setting before undertaking a full study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27797 0
Address 27797 0
Country 27797 0
Phone 27797 0
Fax 27797 0
Email 27797 0
Contact person for public queries
Name 10883 0
Brent Caldwell
Address 10883 0
Wellington School of Medicine
University of Otago
17 Mein Street
PO Box 7434
Wellington
Country 10883 0
New Zealand
Phone 10883 0
+64 4 9186041
Fax 10883 0
Email 10883 0
[email protected]
Contact person for scientific queries
Name 1811 0
Brent Caldwell
Address 1811 0
Wellington School of Medicine
University of Otago
17 Mein Street
PO Box 7434
Wellington
Country 1811 0
New Zealand
Phone 1811 0
+64 4 9186041
Fax 1811 0
Email 1811 0
[email protected]

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
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Documents added automatically
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