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