Overview

Xolair in Patients With Chronic Sinusitis

Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Chicago
Collaborators:
Genentech, Inc.
Novartis Pharmaceuticals
Treatments:
Antibodies
Antibodies, Anti-Idiotypic
Immunoglobulins
Omalizumab
Criteria
Inclusion Criteria:

- Chronic sinusitis, as defined by symptoms for greater than 12 weeks, despite treatment

- Paranasal sinus CT scan showing evidence of chronic sinusitis

- Positive skin or RAST test to an inhalant allergen

- Serum total IgE between 30 and 700 International Units/ml

- Body weight less than 150 kg

- Impaired quality of life, as measured by the Rhinosinusitis Disability Index (RSDI)

Exclusion Criteria:

- Women of childbearing potential not using a contraception method(s) (birth control
pills, Depo Provera, double barrier) as well as women who are breastfeeding

- Known sensitivity to Xolair

- Patients with severe medical condition(s) that, in the opinion of the investigator,
prohibits participation in the study (heart, lung, kidney, neurological, oncologic or
liver disease)

- Use of any other investigational agent in the last 30 days

- No measurable disability on the RSDI

- Immunocompromised patients or patients with ciliary disorders