Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization
Condition: Aspirin Sensitivity
MeSH terms: Hypersensitivity
Intervention: Omalizumab; placebo
Intervention description: Subjects randomized to Omalizumab prior to aspirin desensitization; Subjects randomized to Placebo prior to aspirin desensitization
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 24 week double-blind study in which subjects will be randomized 2:1 to receive
      Xolair (Omalizumab) or placebo. 14 subjects will receive Xolair and 7 will receive placebo.
      Xolair injections will occur every 2-4 weeks. Aspirin desensitization will occur several
      weeks later. One month after desensitization, the final visit will occur in the GCRC.

      We hypothesize that administration of Xolair, a monoclonal anti-IgE antibody, prior to the
      aspirin desensitization will reduce severity of aspirin-induced reaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years.

          -  Fulfill diagnostic criteria for AERD (described below), and be a candidate for aspirin
             desensitization chronic asthma - frequently moderate-severe or severe patients will
             have history compatible with variable airflow obstruction. chronic rhinosinusitis -
             usually requiring previous sinus surgery procedure(s). sinusitis will have been
             confirmed by imaging studies presently and/or in the past.

        history of adverse reaction to aspirin and/or aspirin-like drugs (e.g., ibuprofen,
        naproxen, etc.) compatible with AERD.

        • Candidate for Xolair [Omalizumab] Moderate-severe persistent asthma IgE = 30-700 IU/ml
        IgE mediated (allergic) potential to inhalant allergen(s) by cutaneous or in vitro testing.

        Exclusion Criteria:

          -  Women of childbearing potential not using appropriate contraception method(s)

          -  Women currently breastfeeding

          -  Women who desire to become pregnant during the time of participation in this study

          -  Men who desire to get someone pregnant during participation in this study

          -  Known sensitivity to Xolair [Omalizumab].

          -  IgE level < 30 IU/ml, or > 700 IU/ml.

          -  No evidence of atopy by immediate hypersensitivity skin testing

          -  Use of any other investigational agent in the last 30 days

          -  Age < 18 years.

          -  Current tobacco habituation.

          -  Presence of emphysema

          -  Ethanolism or drug abuse within last 12 months.

          -  Presence of significant medical condition including malignancy, neurologic, kidney,
             gastrointestinal, liver or cardiovascular disease

          -  extensive travel commitments during the study that would interfere with study
             measurements or clinic visits.