Effects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test|
- 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 [ Time Frame: At entry and every 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||April 2008|
|Estimated Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: A
Subjects to receive placebo treatment for 6 months
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.
Subjects to receive Xolair treatment for 6 months
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603785
|Principal Investigator:||Andrew Goldberg, MD||University of California, San Francisco|