Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study
Condition: Treatment Efficacy
Intervention: Peanut Flour
Intervention description: open label oral immunotherapy
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open Label crossover
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 4 Years
Maximum age: 9 Years
Healthy volunteers: No

Summary:

      This application is being submitted as a follow-up to Protocol "Oral Immunotherapy for
      Induction of Tolerance in Peanut Allergic Children-The IMPACT Study." The IMPACT study was a
      double-blind, placebo-controlled study of peanut oral immunotherapy in children 12-48 months
      of age. As part this protocol, all participants who received placebo treatment were promised
      the opportunity to receive open label treatment at the conclusion of the double-blind phase
      and initial follow-up. At the time of submitting that protocol, the investigator did not
      specify any detailed protocol for the open label crossover treatment, as this is an evolving
      field, but the investigator is now ready to offer this open label treatment as promised.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who meet all of the following criteria are eligible for enrollment as study
        participants, including participants who:

          -  Subjects who were randomized to the placebo arm of protocol NA_00077852 "Oral
             Immunotherapy for Induction of Tolerance in Peanut Allergic Children."

          -  Parent guardian must be able to understand and provide informed consent

          -  Peanut allergy, as defined by a reaction to a cumulative dose of ≤1000 mg of peanut
             protein during the End-of-Treatment food challenge from Protocol NA_00077852 "Oral
             Immunotherapy for Induction of Tolerance in Peanut Allergic Children"

        Exclusion Criteria:

        Patients who meet any of these criteria are not eligible for enrollment as study
        participants, including participants who:

          -  Inability or unwillingness of a parent guardian to give written informed consent or
             comply with study protocol

          -  History of severe anaphylaxis to peanut, defined by severe hypoxia, hypotension,
             neurological compromise, confusion, cardiovascular collapse, or loss of consciousness

          -  Significant chronic disease (other than asthma, rhinitis, or atopic dermatitis)
             requiring therapy; e.g., heart disease or cystic fibrosis which is judged by the
             investigator to have potential impact on study outcomes or safety.

          -  Severe or poorly controlled atopic dermatitis per investigator's discretion

          -  Past or current history of eosinophilic gastrointestinal disease

          -  Diagnosis of asthma that meets any of the following criteria:

               -  Uncontrolled asthma (as per Global Initiative for Asthma [GINA] latest
                  guidelines)

               -  History of 2 or more systemic corticosteroid courses or 1 systemic course within
                  the 3 previous months prior to visit 1 for treating wheezing

               -  Prior intubation/mechanical ventilation for asthma

          -  Currently receiving β-blocking agents, angiotensin-converting enzyme inhibitors,
             angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant
             therapy.

          -  Current participation in another clinical trial or participation in another clinical
             trial in the last 90 days