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Keep this study
Lead
Hugh A Sampson, MD
With
National Institute of Allergy and Infectious Diseases (NIAID)
Age
7–35
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject and/or parent/ legal guardian must be able to understand and provide written informed consent
Written or verbal assent from all study subjects less than 18 years (per site Institutional Review Board (IRB) regulations)
7 to 35 years of age; any gender; any racial and ethnic origin
No known contraindications to therapy using oral immunotherapy with milk protein or Xolair® (omalizumab)
All female subjects of childbearing potential must have a negative pregnancy test upon study entry
All treated females of childbearing potential must agree to use FDA approved methods of birth control for the duration of the study
Active Treatment Subjects:
Cow's milk allergy confirmed by a positive double-blind placebo controlled milk challenge (DBPCMC) to a dose of less than 2 g of milk protein within the past 6 months
A skin prick test positive to milk (diameter of wheal \>= 3.0 mm) OR detectable serum milk specific Immunoglobulin E (IgE) level within the previous 12 months (UniCAP \> = 0.35 kUA/L (allergen-equivalent kilounits per liter))
Control Subjects:
A skin prick test positive to milk (diameter of wheal \>= 10.0 mm) OR detectable serum milk specific IgE level within the previous 12 months (UniCAP \>= 15 kUA/L)
You may not be if
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
Clareo Health | OIT and Xolair® (Omalizumab) in Cow's Milk Allergy
