Effects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis

• Status: Withdrawn
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

We propose to study the effects of Xolair on patients with chronic sinusitis with or without nasal polyps. Because of the similarities between the inflammatory processes found in asthmas and rhinitis to those found in chronic sinusitis, we hypothesize that sinusitis should respond to Xolair, just as asthma.

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

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: University of Chicago
• Treatments: Antibodies; Omalizumab

Criteria

Inclusion Criteria:

• Males and females between 18 and 75 years of age

• 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 150kg.

• Impaired quality of life as measured by the Rhinosinusitis Disability Index (RSDI).

Exclusion Criteria:

• Women of childbearing potential not using the 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 conditions that in the view 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.