Xolair in Patients With Chronic Sinusitis

September 27, 2013 updated by: University of Chicago

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

The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At its most basic level, sinusitis is defined as an inflammation of the lining membrane of the paranasal sinuses. Sinusitis affects all age groups, including 17% of people above the age of 65 years. On the basis of national population surveys and insurance-reimbursement claims, sinusitis is one of the most common health problems in the U.S. Thus, each year, billions of dollars are spent on direct medical costs for the treatment of this enigmatic illness.

Despite the enormous cost of the problem, there are no definite studies of treatment and management. There are some data indicating that intranasal steroids are effective, and recently Nasonex was approved for the treatment of nasal polyps. All other treatments are empirically based.

There is evidence that IgE antibodies play a role in chronic sinusitis. The investigators have shown that total IgE levels correlate with the severity of sinusitis, as assessed by CT scan. Staphylococcus enterotoxins cause local increases in total IgE in over 50% of nasal polyp patients. Allergies occur more frequently in patients with chronic sinusitis than in the general population. Elevations in total IgE have been shown to occur in patients with allergic fungal sinusitis and the levels of total IgE decrease with successful treatment. Thus, the investigators speculate that IgE contributes significantly to the pathogenesis of chronic sinusitis.

The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair, will improve objective and subjective evidence of chronic sinusitis.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 150 kg
  • Impaired quality of life, as measured by the Rhinosinusitis Disability Index (RSDI)

Exclusion Criteria:

  • Women of childbearing potential not using a 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 condition(s) that, in the opinion 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Xolair administered subcutaneously, once or twice monthly (dose dependent on subject weight and serum IgE level)
Drug: Anti-IgE antibody omalizumab or placebo
given subcutaneously oce or twice monthly depending on dose
Other Names:
  • Xolair or placebo
Placebo Comparator: 2
placebo administered subcutaneously once or twice monthly
Drug: Anti-IgE antibody omalizumab or placebo
given subcutaneously oce or twice monthly depending on dose
Other Names:
  • Xolair or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mucosal thickness on CT scan
Time Frame: after 6 months of treatment
after 6 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Rhinosinusitis Disability Index (RSDI)recorded monthly
Time Frame: 6 months
6 months
A specific quality of life (QOL) measure, Sino-Nasal Outcome Test (SNOT 20)recorded monthly
Time Frame: 6 months
6 months
A general health QOL measure (SF-36)
Time Frame: 6 months
6 months
The number of sinusitis exacerbations requiring additional treatment
Time Frame: 6 months
6 months
Nasal peak inspiratory flow
Time Frame: 6 months
6 months
Symptoms of nasal discharge, nasal obstruction, facial pain and altered smell
Time Frame: 6 months
6 months
Nasal lavage eosinophils
Time Frame: 6 months
6 months
Nasal endoscopy score
Time Frame: 6 months
6 months
The University of Pennsylvania Smell Identification Test (UPSIT)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Genentech, Inc.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

July 6, 2005

First Posted (Estimate)

July 7, 2005

Study Record Updates

Last Update Posted (Estimate)

September 30, 2013

Last Update Submitted That Met QC Criteria

September 27, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13916A
  • Q2347s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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