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| ID | Type | Description | Link |
|---|---|---|---|
| BB-IND# 12452 |
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Insufficient funds available
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| Name | Class |
|---|---|
| University of Chicago | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | Subjects 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Goldberg, MD | University of California, San Francisco | Principal Investigator |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D015508 | Nasal Obstruction |
| D005157 | Facial Pain |
| D000086582 | Anosmia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Xolair | Drug | 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. |
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009422 | Nervous System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |