Effects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis

Study Overview
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Brief Summary
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We propose to study the effects of Xolair on patients with chronic sinusitis with or without nasal polyps. Because of the similarities between the inflammatory processes found in asthmas and rhinitis to those found in chronic sinusitis, we hypothesize that sinusitis should respond to Xolair, just as asthma.

Detailed Description
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We propose to study the effects of Xolair on patients with chronic sinusitis with or without nasal polyps. Since Xolair has been shown to be effective in asthmatic subjects with evidence of atopy and elevated IgE, we will limit our study to patients with chronic sinusitis and these parameters. The primary objective is to determine if Xolair decreases mucosal thickness on CT scan after 6 months of treatment.

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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Chronic Sinusitis

Intervention / Treatment
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* Drug: Placebo
* Drug: Xolair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between 18 and 75 years of age 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 150kg. Impaired quality of life as measured by the Rhinosinusitis Disability Index (RSDI). Exclusion Criteria: Women of childbearing potential not using the 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 conditions that in the view 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 |
| --- | --- |
| Placebo Comparator: A<br>Subjects to receive placebo treatment for 6 months | Drug: Placebo<br>* Subjects with chronic sinusitis and evidence of atopy and an elevated total IgE (>30 and <700 IU/ml) will be randomized to receive placebo treatment for 6 months.<br>|
| Experimental: B<br>Subjects to receive Xolair treatment for 6 months | Drug: Xolair<br>* Subjects with chronic sinusitis and evidence of atopy and an elevated total IgE (>30 and <700 IU/ml) will be randomized to receive Xolair treatment for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects will have QOL measures (RSDI, SNOT 20, SF-36), NPIF, and nasal lavage repeated. Exacerbations of sinusitis requiring additional treatments will be recorded. Paranasal sinus CT scans will be obtained at the screening and final visits |  | At entry and every 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic sinusitis, Xolair, Nasal Discharge, Nasal Obstruction, Facial Pain, Hyposmia