Inner-City Anti-IgE Therapy for Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: omalizumab; omalizumab placebo
Intervention description: Subcutaneous injections of omalizumab will be administered every 2 or 4 weeks along with standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.; Subcutaneous injections of placebo will be administered every 2 or 4 weeks along with standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 419.0
Sex: All
Minimum age: 6 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Immunoglobulins; Immunoglobulin E; omalizumab; anti-IgE

Summary:

      The purpose of this study is to find out if adding omalizumab to standard asthma treatment
      results in a safer, more effective, and longer lasting asthma treatment strategy than
      standard treatment alone, in inner-city children with mild to severe asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Both body weight and total serum IgE suitable for omalizumab dosing.

          -  Diagnosis of asthma made by a physician more than 1 year prior to study entry OR
             diagnosis of asthma made less than 1 year prior to study entry but have had asthma
             symptoms for longer than 1 year prior to study entry

          -  Are receiving long-term asthma control therapy OR have symptoms consistent with
             persistent asthma OR have evidence of uncontrolled disease

          -  Positive prick skin test to at least one perennial allergen (e.g., dust mite,
             cockroach, mold, cat, dog, rat, mouse)

          -  Live in a preselected zip code are

          -  Able to perform spirometry measurements

          -  Willing to sign informed consent or have parent or guardian willing to provide
             informed consent

          -  Previously had chicken pox or received varicella (chicken pox) vaccine

          -  Have some form of health care insurance that covers costs of medications

        Exclusion Criteria:

        If participant meets any of these criteria, they are not eligible at that time but may be
        reassessed:

          -  Systemic prednisone (or equivalent) during the 2 weeks prior to Visit 2

          -  Systemic prednisone (or equivalent) for more than 30 of the 60 days prior to study
             entry

          -  Pregnancy or breastfeeding

          -  Acute sinusitis or chest infection requiring antibiotics within 1 month of study
             screening

          -  Currently participating in another asthma-related clinical trial or have previously
             participated in an another asthma-related trial within 1 month of study entry

          -  Does not sleep at least 4 nights per week in one home

          -  Lives with a foster parent

          -  Does not have access to a phone

          -  Plans to move during the study

          -  Previously treated with anti-IgE therapy within 1 year of study entry

          -  Currently receiving or received hyposensitization therapy to any allergen in the year
             prior to study entry

          -  Previously received hyposensitization therapy to dust mite, Alternaria, or cockroach
             for more than 6 months in the 3 years prior to study entry

        If participant meets any of these criteria, they are not eligible for the study and may not
        be reassessed:

          -  Significant medical illness. More information on this criterion can be found in the
             protocol.

          -  Certain medications within 4 weeks of study screening. More information on this
             criterion can be found in the protocol.

          -  Known hypersensitivity to any ingredients of omalizumab or related drugs

          -  Diagnosis of cancer, being investigated for possible cancer, or history of cancer

          -  Will not allow study physician to manage their asthma

          -  Does not primarily speak English (or Spanish at centers with Spanish-speaking staff)

          -  History of severe anaphylactoid or anaphylactic reaction(s)