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

Sponsors and Collaborators:	University of California, San Francisco University of Chicago
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00603785

Purpose

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

MedlinePlus related topics: Sinusitis

Drug Information available for: Omalizumab Immunoglobulins Globulin, Immune

U.S. FDA Resources

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

Further study details as provided by University of California, San Francisco:

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 [ Time Frame: At entry and every 4 weeks ] [ Designated as safety issue: No ]

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	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.
B: Experimental 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603785

Sponsors and Collaborators

University of California, San Francisco

University of Chicago

Investigators

Principal Investigator:

Andrew Goldberg, MD

University of California, San Francisco

More Information

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

Keywords provided by University of California, San Francisco:

Chronic sinusitis
Xolair
Nasal Discharge

Nasal Obstruction
Facial Pain
Hyposmia

Study placed in the following topic categories:

Antibodies
Otorhinolaryngologic Diseases
Nasal Obstruction
Respiratory Tract Infections
Respiratory Tract Diseases
Facies

Facial Pain
Chronic Disease
Pain
Sinusitis
Immunoglobulins
Omalizumab

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 14, 2009