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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease (ITN025AD)
Secondary ID [1] 0 0
DAIT ITN025AD
Universal Trial Number (UTN)
Trial acronym
GPAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Allergic Sensitization 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion - 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.
Timepoint [1] 0 0
Three years (36 months) after Treatment Completion
Secondary outcome [1] 0 0
Number of Participants With Current Asthma at Month 36 Status Post Treatment Completion - 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.
Timepoint [1] 0 0
Three years (36 months) after Treatment Completion
Secondary outcome [2] 0 0
Time to First Onset of Asthma - 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.
Timepoint [2] 0 0
From Treatment Initiation to Month 36 Status Post Treatment Completion

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
Minimum age
12 Months
Maximum age
30 Months
Gender
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
VIC,WA
Recruitment hospital [1] 0 0
Royal Children's Hospital - Melbourne
Recruitment hospital [2] 0 0
Telethon Institute for Child Health Research - Perth
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment postcode(s) [2] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Immune Tolerance Network (ITN)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00346398
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. Review.
Nelson HS. Advances in upper airway diseases and allergen immunotherapy. J Allergy Clin Immunol. 2006 May;117(5):1047-53. Epub 2006 Mar 6. Review.
Public notes

Contacts
Principal investigator
Name 0 0
Patrick Holt, MD
Address 0 0
Telethon Institute for Child Health Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications