Xolair in Patients With Chronic Sinusitis

Completed · Phase 4 · Has a placebo group

Conditions studied: Sinusitis

In brief

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.

Key facts

Study ID

NCT00117611

Run by

University of Chicago

People needed

14

Starts

2005-07-01

Expected to finish

2009-01-01

Last updated by the study team

2013-09-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• The University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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