Phase 2
Completed N=51
Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study
Asthma · Allergic Sensitization
Source: ClinicalTrials.gov NCT00346398 ↗
Enrolled (actual)
51
Serious AEs
29.4%
Results posted
Dec 2013
Primary outcomePrimary: Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion — 22; 19 participants — p=0.28
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion |
22; 19 | 0.28 |
| SECONDARY Number of Participants With Current Asthma at Month 36 Status Post Treatment Completion |
4; 4 | 0.85 |
| SECONDARY Time to First Onset of Asthma |
31.0; 38.3 | 0.28 |
Eligibility Criteria
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 subject's ability to take study treatment
- Participated in another clinical study within the 3 months prior to study entry
Data sourced from ClinicalTrials.gov (NCT00346398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.