NCT00603785

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2008-01-29
• Last updated: 2020-02-05