Status:
COMPLETED
Xolair in Patients With Chronic Sinusitis
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Genentech, Inc.
Novartis Pharmaceuticals
Conditions:
Sinusitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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.
Detailed Description
At its most basic level, sinusitis is defined as an inflammation of the lining membrane of the paranasal sinuses. Sinusitis affects all age groups, including 17% of people above the age of 65 years. O...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00117611
Start Date
July 1 2005
End Date
January 1 2009
Last Update
September 30 2013
Active Locations (1)
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1
The University of Chicago
Chicago, Illinois, United States, 60637