Xolair in Patients With Chronic Sinusitis

This study has been completed.
Sponsor:
Collaborators:
Genentech
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00117611
First received: June 30, 2005
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Sinusitis
Drug: Anti-IgE antibody omalizumab or placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Mucosal thickness on CT scan [ Time Frame: after 6 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rhinosinusitis Disability Index (RSDI)recorded monthly [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • A specific quality of life (QOL) measure, Sino-Nasal Outcome Test (SNOT 20)recorded monthly [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • A general health QOL measure (SF-36) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The number of sinusitis exacerbations requiring additional treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Nasal peak inspiratory flow [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Symptoms of nasal discharge, nasal obstruction, facial pain and altered smell [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Nasal lavage eosinophils [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Nasal endoscopy score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: July 2005
Study Completion Date: January 2009
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Xolair or placebo

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117611

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Genentech
Novartis Pharmaceuticals
Investigators
Principal Investigator: Robert M Naclerio, MD University of Chicago
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00117611     History of Changes
Other Study ID Numbers: 13916A, Q2347s
Study First Received: June 30, 2005
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
chronic sinusitis

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Antibodies
Antibodies, Anti-Idiotypic
Omalizumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Allergic Agents
Therapeutic Uses
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014