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

Sponsor

University of California, San Francisco (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00603785

Collaborator

University of Chicago (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Sinusitis	Drug: Placebo Drug: Xolair	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2008

Anticipated Primary Completion Date :

Apr 1, 2008

Anticipated Study Completion Date :

Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: A Subjects to receive placebo treatment for 6 months	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.
Experimental: B Subjects to receive Xolair 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.

Arm

Intervention/Treatment

Placebo Comparator: A

Subjects to receive placebo treatment for 6 months

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.

Experimental: B

Subjects to receive Xolair 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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.