Xolair in Patients With Chronic Sinusitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test

Conditions
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Sinusitis

Intervention / Treatment
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* Drug: Anti-IgE antibody omalizumab or placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Xolair administered subcutaneously, once or twice monthly (dose dependent on subject weight and serum IgE level) | Drug: Anti-IgE antibody omalizumab or placebo<br>* given subcutaneously oce or twice monthly depending on dose<br>* Other names: Xolair or placebo;|
| Placebo Comparator: 2<br>placebo administered subcutaneously once or twice monthly | Drug: Anti-IgE antibody omalizumab or placebo<br>* given subcutaneously oce or twice monthly depending on dose<br>* Other names: Xolair or placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal thickness on CT scan |  | after 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhinosinusitis Disability Index (RSDI)recorded monthly |  | 6 months | 
| A specific quality of life (QOL) measure, Sino-Nasal Outcome Test (SNOT 20)recorded monthly |  | 6 months | 
| A general health QOL measure (SF-36) |  | 6 months | 
| The number of sinusitis exacerbations requiring additional treatment |  | 6 months | 
| Nasal peak inspiratory flow |  | 6 months | 
| Symptoms of nasal discharge, nasal obstruction, facial pain and altered smell |  | 6 months | 
| Nasal lavage eosinophils |  | 6 months | 
| Nasal endoscopy score |  | 6 months | 
| The University of Pennsylvania Smell Identification Test (UPSIT) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic sinusitis