None listed
Conditions
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 months
Sponsors
National Institute of Allergy and Infectious Diseases
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
12 Months to 30 Months
Healthy volunteers
No
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
Outcome results
None listed