Baked Milk Oral Immunotherapy for Cow's Milk Allergy
Condition: Cow's Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Intervention: Baked non-fat cow's milk powder; Placebo: Tapioca Powder
Intervention description: Oral immunotherapy with increasing quantities of baked milk.; Placebo control.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Placebo controlled
Enrollment: 41.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: food allergy; oral immunotherapy

Summary:

      The purpose of this study is to determine whether baked milk oral immunotherapy is safe in
      the treatment of cow's milk allergy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who meet all of the following criteria are eligible for enrollment as study
             participants, including participants who:

               -  Are age 3-18 years, either sex, any ethnicity or race

               -  Provide signed informed consent by parent or legal guardian and informed assent
                  if applicable

               -  Have a history of symptomatic reactivity to cow's milk (i.e. eczema, urticarial,
                  upper or lower respiratory symptoms, gastrointestinal disturbances, rash, oral
                  symptoms)

               -  Have a skin prick test positive to milk (diameter of wheal 3 mm ≥ negative
                  control) and serum milk-specific immunoglobulin E (IgE) level >5 kilo Units
                  (kU)/L within the past 6-12 months

               -  Have a positive reaction to a cumulative dose of ≤444 mg of baked milk powder in
                  the initial qualifying double blind placebo-controlled food challenge.

               -  Use an effective method of contraception by females of childbearing potential to
                  prevent pregnancy and agree to continue to practice an acceptable method of
                  contraception for the duration of their participation in the study.

               -  Have self-injectable epinephrine available at all times

        Exclusion Criteria:

          -  Patients who meet any of these criteria are not eligible for enrollment as study
             participants, including participants who:

               -  Have a history of severe anaphylaxis resulting in hypotension, neurological
                  compromise, or mechanical ventilation

               -  Have a history of intubation related to asthma

               -  Tolerate more than 444 mg of baked milk powder at the initial qualifying double
                  blind placebo controlled food challenge.

               -  Allergy to placebo ingredients or reacts to any dose of placebo during the
                  qualifying oral food challenge.

               -  Poor control of atopic dermatitis

               -  Are unable to tolerate at least 3 mg of baked milk protein on dose escalation day

               -  Are pregnant or lactating

               -  Have severe asthma defined by 2007 National Heart Lung and Blood Institute
                  (NHLBI) Criteria Steps 5 or 6

               -  Have severe or poorly controlled asthma defined by with any of the following
                  criteria:

                    1. Forced expiratory volume in 1 second (FEV1) <80% of predicted

                    2. Inhaled corticosteroid dosing dosing of >500 mcg daily of fluticasone (or
                       equivalent inhaled corticosteroids based on NHLBI dosing chart) or

                    3. ≥ 1 hospitalization in the past year for asthma or

                    4. > 1 emergency department visit in the past 6 months for asthma

               -  Use of steroid medications (oral steroids, such as prednisone or Medrol, steroid
                  injections, such as Kenalog, or intravenous or oral corticosteroid burst) in the
                  following manners: History of daily oral steroid dosing within 4 weeks prior to
                  baseline visit or for > 1 month during the past year or >2 burst oral steroid
                  courses in the past 6 months.

               -  Are unable to discontinue antihistamines for 5 days for long acting and 3 days
                  for short acting prior to skin testing or food challenges

               -  Are receiving omalizumab, mepolizumab, beta- blocker,
                  angiotensin-converting-enzyme inhibitor (ACE-I), angiotensin-receptor blockers,
                  calcium channel blockers, or tricyclic antidepressant therapy

               -  Have used immunomodulatory therapy (not including corticosteroids) or biologic
                  therapy within the past year

               -  Have participated in any interventional study for treatment of a food allergy in
                  the past 6 months

               -  Are on 'build up phase' of environmental allergen immunotherapy. Subjects
                  tolerating maintenance allergen immunotherapy can be enrolled.

               -  Have a history of eosinophilic esophagitis in the past 3 years

               -  Have a chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring
                  therapy (e.g., heart disease, diabetes)

               -  Have used an investigational drug within 90 days or plan to use an
                  investigational drug during the study period

               -  Severe reaction at initial double blind placebo controlled food challenge,
                  defined as:

                    -  Life-threatening anaphylaxis

                    -  Requiring overnight hospitalization