Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations

Inclusion Criteria

• Combined body weight (as measured at the screening visit) and total serum IgE level (as measured within 3 months of the screening visit) suitable for omalizumab (Xolair®) dosing;
• A diagnosis of asthma by a clinician made more than 1 year prior to recruitment; participants who received an asthma diagnosis by a clinician less than 1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment;
• Having a requirement for at least 100 mcg fluticasone 100 mcg twice a day or equivalent at the Assumption of Care Visit AND who meet at least one of the following criteria:

i. ≥1 asthma-related exacerbations, separated by at least two weeks, requiring treatment with a systemic corticosteroid course in the previous 12 months ii. ≥1 asthma-related overnight hospitalizations in the past 12 months.

• A positive prick skin-test to at least one perennial allergen (i.e. dust mite, cockroach, mold, cat, dog, rat, mouse) documented at the screening visit or at a ICAC study visit within 12 months of the screening visit;
• Primary place of residence is in one of the pre-selected recruitment census tracts;
• Able to perform spirometry;
• Parent or legal guardian is willing to sign the written informed consent (age appropriate) prior to initiation of any study procedure;
• Willing to sign the assent form, if age appropriate;
• A history of chickenpox or receipt of the chickenpox vaccine;
• Insurance which covers costs of medications; and
• Have not used and do not plan to restart any of the following medications in the 7 days prior to the first visit: tricyclic antidepressants, ketaconazole, or beta adrenergic blocker drugs (oral and/or topical).

Exclusion Criteria

Participants who meet any of the following criteria are not eligible for enrollment but may be reassessed:

• Assigned to a treatment of less than 100 mcg fluticasone twice a day or equivalent at the Assumption of Care Visit;
• Pregnant or lactating. Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception);
• Clinically significant laboratory abnormalities (not associated with the study indication) at the screening visit;
• Platelet count less than 100 x 10^9/L at the screening visit;
• Currently participating in another asthma-related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior to Recruitment;
• Living with a foster parent: exception -not applicable if participant is able to provide consent;
• Does not have access to a phone (needed for scheduling appointments);
• Plan(s) to move from the area during the study period;
• Has previously been treated with omalizumab (Xolair®) within 1 year of recruitment;
• Currently receiving or has received hyposensitization therapy to any allergen in the past year prior to recruitment;
• Has received hyposensitization therapy to dust mite, Alternaria or cockroach for ≥ 6 months in the past 3 years prior to Recruitment;
• Has experienced a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure;
• Home-schooled or in year round school;
• Are currently taking or who have taken any of the following medications within 4 weeks of the Screening Visit: monoamine oxidase inhibitors (phenelzine, tranylcypromine); tricyclic and tetracyclic antidepressants; beta adrenergic blocker drugs (both oral and topical); anticonvulsants(carbamazepine, phenobarbital, phenytoin, mephobarbital, primidone,ethosuximide, methsuximide, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproic acid, divalproex sodium, zonisamide); protease inhibitors(ritonavir, indinavir, nelfinavir); calcium channel blockers (verapa