OIT and Xolair® (Omalizumab) in Cow's Milk Allergy

Exclusion Criteria

• •A history of life-threatening anaphylaxis to milk (involving hypotension or requiring mechanical ventilation)
• •Known allergy to any components of the placebo for Xolair®
• •Chronic disease other than asthma, atopic dermatitis, or allergic rhinitis requiring therapy (e.g., heart disease, diabetes)
• •Use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB), or calcium channel blockers
• •Severe asthma
• •Mild or moderate asthma with any of the following criteria met:
• •* Forced expiratory volume in the first second (FEV1) \< 80% with or without controller medications
• •* Inhaled corticosteroids (ICS) dosing of \>500 mcg daily fluticasone (or equivalent inhaled corticosteroids based on NHLBI dosing chart)
• •* history of daily oral steroid dosing for \>1 month during the past year
• •* burst oral steroid course in the past 6 months
• •* more than one burst oral steroid course in the past year
• •* more than one hospitalization in the past year for asthma, or
• •* more than one ER visit in the past 6 months for asthma
• •Baseline spirometry (or peak flow rate (PFR) if unable to perform spirometry) result of FEV1\<80%
• •Pregnancy or lactation. All females of child-bearing age will undergo pregnancy testing. All treated females will confirm compliance to appropriate birth control measures throughout the course of the study;
• •Participation in any interventional study for the treatment of food allergy in the past 6 months
• •Subject is on a buildup phase of standard subcutaneous immunotherapy for inhalant allergens (may be enrolled on maintenance dose);
• •Use of Xolair® (omalizumab) or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual immunotherapy) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
• •Inability to discontinue antihistamines for 5 half-lives prior to routine study tests (DBPCMC or endpoint titration tests)
• •Known sensitivity to Xolair® (omalizumab) or to the class of study drugs
• •Baseline serum total IgE over 1,300 IU/mL or body weight more than 150 kg, or subjects with weight-IgE combination that yields a dose requirement greater than 750 mg (due to limitations of Xolair® (omalizumab) dosing)
• •Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements
• •Inability or unwillingness of a subject to give written informed consent or comply with study protocol
• •Use of investigational drugs within 90 days of participation
• •Other contraindications to milk oral immunotherapy or Xolair® (omalizumab)
• •Recipient of any licensed or investigational live attenuated vaccine(s) within 2 months of enrollment
• •Families who do not speak English
• •Systemic steroids oral, intramuscular (IM), or IV for indications other than asthma for greater than 3 weeks in the past 6 months