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Sponsors and Collaborators: |
University of Chicago Genentech Novartis |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00117611 |
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.
Condition | Intervention | Phase |
---|---|---|
Sinusitis |
Drug: Anti-IgE antibody omalizumab or placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test |
Estimated Enrollment: | 50 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Xolair administered subcutaneously, once or twice monthly (dose dependent on subject weight and serum IgE level)
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Drug: Anti-IgE antibody omalizumab or placebo
given subcutaneously oce or twice monthly depending on dose
|
2: Placebo Comparator
placebo administered subcutaneously once or twice monthly
|
Drug: Anti-IgE antibody omalizumab or placebo
given subcutaneously oce or twice monthly depending on dose
|
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. On the basis of national population surveys and insurance-reimbursement claims, sinusitis is one of the most common health problems in the U.S. Thus, each year, billions of dollars are spent on direct medical costs for the treatment of this enigmatic illness.
Despite the enormous cost of the problem, there are no definite studies of treatment and management. There are some data indicating that intranasal steroids are effective, and recently Nasonex was approved for the treatment of nasal polyps. All other treatments are empirically based.
There is evidence that IgE antibodies play a role in chronic sinusitis. The investigators have shown that total IgE levels correlate with the severity of sinusitis, as assessed by CT scan. Staphylococcus enterotoxins cause local increases in total IgE in over 50% of nasal polyp patients. Allergies occur more frequently in patients with chronic sinusitis than in the general population. Elevations in total IgE have been shown to occur in patients with allergic fungal sinusitis and the levels of total IgE decrease with successful treatment. Thus, the investigators speculate that IgE contributes significantly to the pathogenesis of chronic sinusitis.
The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair, will improve objective and subjective evidence of chronic sinusitis.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
The University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Robert M Naclerio, MD | University of Chicago |
Responsible Party: | University of Chicago ( Robert Naclerio, MD ) |
Study ID Numbers: | 13916A, Q2347s |
Study First Received: | June 30, 2005 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00117611 |
Health Authority: | United States: Institutional Review Board |
chronic sinusitis |
Antibodies Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Sinusitis Immunoglobulins Omalizumab |
Respiratory System Agents Immunologic Factors Paranasal Sinus Diseases Therapeutic Uses Physiological Effects of Drugs |
Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Nose Diseases |