Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study

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 high risk for developing the disease.

Official Title

A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease

Conditions

• Asthma
• Allergic Rhinitis

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

• Primary Outcomes: Allergic sensitization in children at high risk of asthma and atopy
• Secondary Outcomes: Incidence of asthma in children at high risk for developing asthma and atopy; effects of OMIP on the immune response to allergens

Study Start

May 2006; Expected completion: September 2012

Eligibility & Criteria

• Ages Eligible for Study: 18 Months – 30 Months
• Genders Eligible for Study: Both

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

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 volunteer’s ability to take study treatment
• Participated in another clinical study within the 3 months prior to study entry

Total Enrolment

200 (expected)

Contact Details

Carlie Dunford 61 8 9489 7813 carlied@ichr.uwa.edu.au