Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study
Condition: Asthma; Allergic Sensitization
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Researchers suspect that allergies to common inhaled allergens (such as house dust mite, cat
      dander, and grass pollens) are a major cause of childhood asthma. Recent evidence suggests
      that if allergies to inhaled allergens are prevented, this can cause changes in the immune
      system that may inhibit the development of asthma. Although strategies to prevent allergies
      generally focus on avoiding the allergen, complete avoidance of the common allergens linked
      to asthma would require extreme measures and is impractical.

      Oral mucosal immunoprophylaxis (OMIP) therapy is an allergy treatment that can induce
      long-lasting immune tolerance in people already suffering from allergies. By exposing the
      patient to small, repeated, but increasing doses of the problem allergen over a long period
      of time, the patient's immune system is eventually desensitized to that particular allergen.
      OMIP therapy has been shown to be safe in children as young as 2 years old. This study will
      evaluate if OMIP therapy against common inhaled allergens is safe and effective in preventing
      the development of asthma in children at high risk for developing the disease. Children
      enrolled in this study have been diagnosed with eczema or food allergies and have a family
      history of eczema, allergic rhinitis, or asthma.

      There are two groups in this study. The experimental arm participants will receive OMIP
      therapy (a mixture of house dust mite, cat, and timothy grass allergens) as daily oral drops
      under the tongue for 1 year; Placebo arm participants will receive an allergen free placebo
      solution. Participants will be followed for an additional 3 years to see whether they develop
      allergies or asthma and to determine how OMIP affects their immune system's response to
      allergens. There will be 5 study visits in the first year and 6 visits over the next 3 years.
      At all visits, participants will be assessed for allergy/asthma symptoms, will be asked to
      complete questionnaires, and may be asked to provide blood or saliva samples.
    

Intervention name(s): Oral mucosal immunoprophylaxis (OMIP); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): OMIP consists of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL.; The placebo consists of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL.
Other intervention name(s): Allergen immunotherapy
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: asthma; allergen; allergic disease; allergen immunotherapy; allergic sensitization; atopic dermatitis; eczema; food allergy; oral mucosal immunoprophylaxis (OMIP)