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

NCT ID: NCT00603785

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-04-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Subjects to receive placebo treatment for 6 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

B

Subjects to receive Xolair treatment for 6 months

Group Type: EXPERIMENTAL

Xolair

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Other Identifiers

BB-IND# 12452

Identifier Type: -

Identifier Source: secondary_id

07030836

Identifier Type: -

Identifier Source: org_study_id