omalizumab in severe asthmatics with food allergy

Conditions: Food; Allergy, Anaphylactic Shock; Asthma in Children

Summary: a prospective assessment of the impact of omalizumab in terms of efficacy, safety, and quality of life (fa-qol) in patients with moderate/severe asthma and history of anaphylaxis to peanut, tree nuts, fish, egg, milk, and/or wheat. evaluation of the trend of total and specific ige during omalizumab treatment.

children (6-18 yrs) with severe asthma eligible for treatment with omalizumab and reporting food anaphylaxis to be assessed for their concomitant food allergy. at t0: * oral food challenges (ofcs) to establish the threshold of reaction to the culprit food(s); * number and severity of food-allergic reactions in the previous 12 months recorded * asthma control test * food allergy-quality of life (fa-qol) questionnaire * total ige * specific ige for the culprit foods at t1 - four months after starting omalizumab treatment: * ofcs to the previously positive foods with evaluation of the threshold of reaction * number and severity of food-allergic reactions in the previous 4 months recorded * asthma control test * food allergy-quality of life (fa-qol) questionnaire * total ige * specific ige for the culprit foods at t2 - eight months after starting omalizumab treatment: * ofcs to the previously positive foods with evaluation of the threshold of reaction * number and severity of food-allergic reactions in the previous 4 months recorded * asthma control test * food allergy-quality of life (fa-qol) questionnaire * total ige * specific ige for the culprit foods at t1 - twelve months after starting omalizumab treatment: * ofcs to the previously positive foods with evaluation of the threshold of reaction * number and severity of food-allergic reactions in the previous 4 months recorded * asthma control test * food allergy-quality of life (fa-qol) questionnaire * total ige * specific ige for the culprit foods

Eligibility criteria:
inclusion criteria: * age 6 - 18 years * severe persistent allergic asthma according to the gina guidelines * sensitized to a perennial aeroallergen, as witnessed by positive skin test and/or in vitro reactivity * symptoms inadequately controlled with inhaled corticosteroids + another medication, as witnessed by an act ≤ 19 * on treatment with high dose inhaled corticosteroids + another medication. threshold dose for inhaled corticosteroids set at 400 mcg/day budesonide (or equivalent doses) for children \< 12 years, at 800 mcg/day for older patients. * immediate food allergy with anaphylactic symptoms within 1hr. of ingestion of milk, egg, wheat, peanut, hazelnut, and/or codfish. * total ige \ 1,500 ku/l at baseline * sensitivity to food allergen documented by a positive skin prick test result and/or allergen-specific ige level, with 0.35 ku/l as a lower limit of eligibility * positive ofc within the past 12 months, with minimal or no reactions to the placebo challenge. * trained on the proper use of epinephrine * in case of female subjects of child-bearing potential, negative human chorionic gonadotropin blood sample for pregnancy testing * no known contraindications to oral immunotherapy with food protein or omalizumab * parent/legal guardian written informed consent exclusion criteria: * total ige at screening \> 70 or ≤ 2,500 kui/l * allergy to food(s) not investigated in this study * immune deficiency * previous reaction to omalizumab * previous organ transplantation * use of monoclonal antibodies in the previous 6 months * subjects with gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease. * subjects who have received an experimental drug in the last 30 days prior to admission into this study or who plan to use an experimental drug during the study * pregnant or breast-feeding females. * subjects with food protein induced enterocolitis syndrome (fpies) * subjects is on a build-up phase of standard subcutaneous immunotherapy for inhalant allergens (may be enrolled on maintenance dose) * inability to discontinue antihistamines for 5 half-lives prior to routine study tests (ofc) * subjects with weight-ige combination yielding a dose requirement greater than 600 mg according to the ema schedule for omalizumab * systemic steroids oral, im, or iv for indications other than asthma for more than 3 weeks in the past 6 months.