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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00346398
Registration number
NCT00346398
Ethics application status
Date submitted
27/06/2006
Date registered
29/06/2006
Date last updated
1/05/2017
Titles & IDs
Public title
Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study
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Scientific title
A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease (ITN025AD)
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Secondary ID [1]
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DAIT ITN025AD
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Universal Trial Number (UTN)
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Trial acronym
GPAC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Allergic Sensitization
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Oral mucosal immunoprophylaxis (OMIP)
Other interventions - Placebo
Experimental: Oral mucosal immunoprophylaxis (OMIP) - Participants are administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months.
Placebo Comparator: Placebo - Participants are administered, via the same route as the experimental group, an oral placebo solution daily for 12 months.
Other interventions: Oral mucosal immunoprophylaxis (OMIP)
OMIP consists of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL.
Other interventions: Placebo
The placebo consists of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion
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Assessment method [1]
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Allergic sensitization is defined as a positive serum allergen specific Immunoglobulin E (IgE) CAP test[1] or a positive allergy skin prick test[2]. Not experiencing allergic sensitization is the better outcome for this measure.
A positive serum allergen specific IgE CAP (ImmunoCAP) test result is defined by a result >= 0.35 kU/L. Higher scores indicate greater allergic sensitization.
A positive skin prick test is defined as a wheal diameter that is 3 mm larger than that produced by a negative control. Higher wheal sizes indicate greater allergic reaction or sensitization.
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Timepoint [1]
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Three years (36 months) after Treatment Completion
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Secondary outcome [1]
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Number of Participants With Current Asthma at Month 36 Status Post Treatment Completion
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Assessment method [1]
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Participants who currently have asthma three years after end of treatment. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze. Current asthma is defined as a diagnosis of asthma and at least one episode of wheeze lasting 3 or more consecutive days in the past 12 months.
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Timepoint [1]
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Three years (36 months) after Treatment Completion
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Secondary outcome [2]
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Time to First Onset of Asthma
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Assessment method [2]
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Time to first onset of asthma is the time from the day a participant is randomized and initiates study treatment to the diagnosis of the first of three episodes of asthma. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze.
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Timepoint [2]
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From Treatment Initiation to Month 36 Status Post Treatment Completion
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Eligibility
Key inclusion criteria
- Diagnosed with eczema (atopic dermatitis)
- Family history of eczema, allergic rhinitis, or asthma
- Allergy to one or more of the following: egg white, cow's milk, peanut, or soybean
- Weigh at least 9.5 kg (20.9 lbs)
- Parent or guardian willing to provide informed consent
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Minimum age
12
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Maximum age
30
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Allergy to house dust mite, cat, or timothy grass
- Born prematurely (before 36th week's gestation)
- Previous diagnosis of asthma OR have had 3 or more distinct episodes of wheeze during
the first year of life
- Chronic pulmonary disease
- Chronic disease requiring therapy
- Past or current treatment with systemic immunomodulator medication
- Past or current treatment with allergen-specific immunotherapy
- Received 10 or more days of systemic steroids in the 3 months prior to study entry
- Orofacial abnormalities that are likely to interfere with the subject's ability to
take study treatment
- Participated in another clinical study within the 3 months prior to study entry
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2011
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Sample size
Target
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Accrual to date
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Final
51
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Royal Children's Hospital - Melbourne
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Recruitment hospital [2]
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Telethon Institute for Child Health Research - Perth
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Recruitment postcode(s) [1]
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3052 - Melbourne
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Recruitment postcode(s) [2]
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6008 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Funding & Sponsors
Primary sponsor type
Government body
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Name
National Institute of Allergy and Infectious Diseases (NIAID)
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Immune Tolerance Network (ITN)
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether early childhood exposure to common
allergens (substances that can trigger allergies and asthma) can prevent the development of
asthma in children at high risk for developing the disease.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00346398
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Trial related presentations / publications
Mascarell L, Van Overtvelt L, Moingeon P. Novel ways for immune intervention in immunotherapy: mucosal allergy vaccines. Immunol Allergy Clin North Am. 2006 May;26(2):283-306, vii-viii. doi: 10.1016/j.iac.2006.02.009.
Nelson HS. Advances in upper airway diseases and allergen immunotherapy. J Allergy Clin Immunol. 2006 May;117(5):1047-53. doi: 10.1016/j.jaci.2005.12.1306. Epub 2006 Mar 6.
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Public notes
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Contacts
Principal investigator
Name
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Patrick Holt, MD
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Address
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Telethon Institute for Child Health Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00346398
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