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
Study Type
OBSERVATIONAL
Enrollment
65
Administration of Omalizumab at the doses indicated for asthma in the EMA information leaflet.
Pediatric Hospital Bambino Gesù IRCCS - Allergy Dpt
Roma, Italy
Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1.
Threshold of reactivity assessed as No Observed Adverse Events Level (NOAEL) to each of the analysed food
Time frame: Four months (T1)
Proportion of negative OFCs at T1
Percentage of OFC tolerated until the last dose of food.
Time frame: Four months (T1)
NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T2.
Change in the NOAEL at the third OFC to the foods who did not pass the OFC at T1
Time frame: Eight months (T2)
NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T3.
Change in the NOAEL at the fourth OFC to the foods who did not pass the OFC at T2
Time frame: Twelve months (T3)
Change in number of anaphylactic events
Number of episodes of anaphylaxis in the 6 - 12 months preceding T0 compared with those 6 - 12 months after the first dose of Omalizumab
Time frame: Twelve months (T3)
Rate of severity of anaphylactic events
Severity of episodes of anaphylaxis in the 6 - 12 months preceding T0 compared with those 6 - 12 months after the first dose of Omalizumab; PRACTALL score: 1 - mild, 2 - moderate, 3 - severe.
Time frame: Twelve months (T3)
Asthma Control Test (ACT)
Change from baseline in ACT score: 5 worse, 25 better outcome
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Time frame: Twelve months (T3)
Quality of Life score
Change from baseline in age-appropriate FA-QoL score: 0, better; 84, worse outcome
Time frame: Four (T1), eight (T2), twelve (T3) months
Total IgE
Change from baseline in total IgE
Time frame: Four (T1), eight (T2), twelve (T3) months
Specific IgE for milk, egg, hazelnut, peanut, wheat, and/or fish
Change from baseline in sIgE;
Time frame: Four (T1), eight (T2), twelve (T3) months