Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000633482
Ethics application status
Approved
Date submitted
10/08/2007
Date registered
12/12/2007
Date last updated
12/12/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Global Prevention of Asthma in Children Study
Scientific title
A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease
Secondary ID [1] 456 0
ClinicalTrials.gov - NCT00346398
Universal Trial Number (UTN)
Trial acronym
GPAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis 2247 0
Asthma 2626 0
Condition category
Condition code
Respiratory 2743 2743 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
House Dust Mites - 7.5 mcg/0.2ml (Dermatophagoides pteronyssinus & Dermatophagoides farinae); Cat (11.3 mcg/0.2ml) and Timothy Grass (15.0 mcg/0.2ml) or matching placebo orally once daily for 12 months
Intervention code [1] 2362 0
Prevention
Comparator / control treatment
Sham allergen - 0.6ml orally once daily for 12 months
Control group
Placebo

Outcomes
Primary outcome [1] 3630 0
To assess whether oral immunoprophylaxis reduces allergic sensitization to any of the treatment mix allergens 3 years after the end of treatment. This will be measured via a skin prick test.
Timepoint [1] 3630 0
4 years
Secondary outcome [1] 6082 0
To assess whether oral immunoprophylaxis reduces the incidence of asthma 3 years after completing treatment. This will be assessed by incidences of wheeze and/or doctor diagnosis
Timepoint [1] 6082 0
4 years

Eligibility
Key inclusion criteria
1. Diagnosed with eczema (atopic dermatitis)
2. Family history of eczema, allergic rhinitis, or asthma
3. Allergy to one or more of the following: egg white, cow’s milk, peanut, or soybean
4. Weigh at least 8.0 kg
5. Parent or guardian willing to provide informed consent
Minimum age
12 Months
Maximum age
30 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Allergy to house dust mite, cat, or timothy grass
2. Born prematurely (before 36th week's gestation) 3. Previous diagnosis of asthma OR have had 3 or more distinct episodes of wheeze during the first year of life
3. Chronic pulmonary disease
4. Chronic disease requiring therapy
5. Past or current treatment with systemic immunomodulator medication
6. Past or current treatment with allergen-specific immunotherapy
7. Received 10 or more days of systemic steroids in the 3 months prior to study entry
8. Orofacial abnormalities that are likely to interfere with the volunteer's ability to take study treatment
9. Participated in another clinical study within the 3 months prior to study entry

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)
central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized in blocks to the treatment group or the placebo group using a one-to-one ratio. Randomization will be stratified by investigational site to ensure an approximately equal allocation to each group within each site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Double blind placebo controlled randomised clinical trial
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 211 0
6008
Recruitment postcode(s) [2] 212 0
3052
Recruitment outside Australia
Country [1] 559 0
United States of America
State/province [1] 559 0
New York
Country [2] 560 0
Germany
State/province [2] 560 0
Berlin
Country [3] 561 0
Sweden
State/province [3] 561 0
Stockholm

Funding & Sponsors
Funding source category [1] 2881 0
Government body
Name [1] 2881 0
Immune Tolerance Network
Country [1] 2881 0
United States of America
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases
Address
Room 3093
6610 Rockledge Drive
Bethesda MD 20892-7640
Country
United States of America
Secondary sponsor category [1] 2598 0
None
Name [1] 2598 0
None
Address [1] 2598 0
None
Country [1] 2598 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4819 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 4819 0
Roberts Road
Subiaco WA 6008
Ethics committee country [1] 4819 0
Australia
Date submitted for ethics approval [1] 4819 0
Approval date [1] 4819 0
18/09/2003
Ethics approval number [1] 4819 0

Summary
Brief summary
Trial website
wwww.globalasthmastudy.com
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 27977 0
Address 27977 0
Country 27977 0
Phone 27977 0
Fax 27977 0
Email 27977 0
Contact person for public queries
Name 11134 0
Peter Sly
Address 11134 0
100 Roberts Road
Subiaco WA 6008
Country 11134 0
Australia
Phone 11134 0
+61 8 94897777
Fax 11134 0
+61 9 94897700
Email 11134 0
[email protected]
Contact person for scientific queries
Name 2062 0
Peter Sly
Address 2062 0
100 Roberts Road
Subiaco WA 6008
Country 2062 0
Australia
Phone 2062 0
+61 8 94897810
Fax 2062 0
+61 9 94897700
Email 2062 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.