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Xolair in Patients With Chronic Sinusitis

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ClinicalTrials.gov Identifier: NCT00117611
Recruitment Status : Completed
First Posted : July 7, 2005
Last Update Posted : September 30, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Sinusitis Drug: Anti-IgE antibody omalizumab or placebo Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 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 : July 2005
Primary Completion Date : May 2007
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
Drug Information available for: Omalizumab
U.S. FDA Resources

Arms and Interventions

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 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


Outcome Measures

Primary Outcome Measures :
  1. Mucosal thickness on CT scan [ Time Frame: after 6 months of treatment ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117611


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

Publications:

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
First Posted: July 7, 2005    Key Record Dates
Last Update Posted: September 30, 2013
Last Verified: September 2013

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
Immunoglobulins
Antibodies, Anti-Idiotypic
Omalizumab
Immunologic Factors
Physiological Effects of Drugs
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents