Status:
COMPLETED
Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Asthma
Allergic Sensitization
Eligibility:
All Genders
12-30 years
Phase:
PHASE2
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 h...
Detailed Description
Researchers suspect that allergies to common inhaled allergens (such as house dust mite, cat dander, and grass pollens) are a major cause of childhood asthma. Recent evidence suggests that if allergie...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00346398
Start Date
May 1 2006
End Date
July 1 2011
Last Update
May 1 2017
Active Locations (3)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029
2
Royal Children's Hospital
Melbourne, Victoria, Australia, 3052
3
Telethon Institute for Child Health Research
Perth, Western Australia, Australia, 6008