Overview

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.