ACTRN12607000633482RecruitingPhase 2
A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease
ational Institute of Allergy and Infectious Diseases0 sites200 target enrollmentStarted: December 12, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 12 Months to 30 Months (—)
- Sex
- All
Inclusion Criteria
- •1. Diagnosed with eczema (atopic dermatitis)
- •2. Family history of eczema, allergic rhinitis, or asthma
- •3. Allergy to one or more of the following: egg white, cow’s milk, peanut, or soybean
- •4. Weigh at least 8.0 kg
- •5. Parent or guardian willing to provide informed consent
Exclusion Criteria
- •1. Allergy to house dust mite, cat, or timothy grass
- •2. 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
- •3. Chronic pulmonary disease
- •4. Chronic disease requiring therapy
- •5. Past or current treatment with systemic immunomodulator medication
- •6. Past or current treatment with allergen-specific immunotherapy
- •7. Received 10 or more days of systemic steroids in the 3 months prior to study entry
- •8. Orofacial abnormalities that are likely to interfere with the volunteer's ability to take study treatment
- •9. Participated in another clinical study within the 3 months prior to study entry
Investigators
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