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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00346398




Registration number
NCT00346398
Ethics application status
Date submitted
27/06/2006
Date registered
29/06/2006

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
Treatment: Other - Oral mucosal immunoprophylaxis (OMIP)
Treatment: Other - 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.


Treatment: Other: 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.

Treatment: Other: 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
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion
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
Timepoint [1] 0 0
Three years (36 months) after Treatment Completion
Secondary outcome [2] 0 0
Time to First Onset of Asthma
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
Sex
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
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
51
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data access is provided to the public in: 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools available to researchers; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal that makes data from the consortium's clinical trials publicly available.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Holt PG, Sly PD, Sampson HA, Robinson P, Loh R, Lo... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT00346398