Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Lang
• Collaborator: Genentech, Inc.
• Treatments: Aspirin; Omalizumab

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.