Phase 2 N=51 Randomized Double-blind Prevention

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

Asthma · Allergic Sensitization

Bottom Line

View on ClinicalTrials.gov: NCT00346398 ↗

Enrolled (actual)

Serious AEs

29.4%

Results posted

Dec 2013

Primary outcome: Primary: Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion — 22; 19 participants — p=0.28

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Oral mucosal immunoprophylaxis (OMIP) (Biological); Placebo (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Jul 2011

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

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.

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

View full record on ClinicalTrials.gov →

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.