RecruitingPhase 2ACTRN12607000633482
Global Prevention of Asthma in Children Study
A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease
Sponsor
National Institute of Allergy and Infectious Diseases
Enrollment
200 participants
Start Date
Jun 1, 2006
Study Type
Interventional
Conditions
Eligibility
Sex: Both males and femalesMin Age: 12 MonthssMax Age: 30 Monthss
Inclusion Criteria5
- 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 8.0 kg
- Parent or guardian willing to provide informed consent
Exclusion Criteria9
- Allergy to house dust mite, cat, or timothy grass
- 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
- 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 volunteer's ability to take study treatment
- Participated in another clinical study within the 3 months prior to study entry
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Interventions
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 month
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
Locations(3)
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ACTRN12607000633482
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