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Sponsors and Collaborators: |
University of California, San Francisco University of Chicago |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00603785 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Sinusitis |
Drug: Placebo Drug: Xolair |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test |
Estimated Enrollment: | 25 |
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) |
Arms | Assigned Interventions |
---|---|
A: Placebo Comparator
Subjects to receive placebo treatment for 6 months
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Drug: Placebo
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.
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B: Experimental
Subjects to receive Xolair treatment for 6 months
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Drug: Xolair
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.
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of California, San Francisco ( Andrew Goldberg, MD ) |
Study ID Numbers: | 07030836, BB-IND# 12452 |
Study First Received: | January 11, 2008 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00603785 |
Health Authority: | United States: Food and Drug Administration |
Chronic sinusitis Xolair Nasal Discharge |
Nasal Obstruction Facial Pain Hyposmia |
Antibodies Otorhinolaryngologic Diseases Nasal Obstruction Respiratory Tract Infections Respiratory Tract Diseases Facies |
Facial Pain Chronic Disease Pain Sinusitis Immunoglobulins Omalizumab |
Disease Attributes Pathologic Processes Paranasal Sinus Diseases Nose Diseases |