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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma, Allergic Sensitization

In brief

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.

Key facts

Study ID

NCT00346398

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

51

Starts

2006-05-01

Expected to finish

2011-07-01

Last updated by the study team

2017-05-01

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States
• Royal Children's Hospital — Melbourne, Victoria, Australia
• Telethon Institute for Child Health Research — Perth, Western Australia, Australia

Full record on ClinicalTrials.gov

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