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

This study has been withdrawn prior to enrollment.
(Insufficient funds available)
Sponsor:
Collaborator:
University of Chicago
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00603785
First received: January 11, 2008
Last updated: September 15, 2011
Last verified: September 2011
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

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

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
Placebo Comparator: A
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.
Experimental: B
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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00603785     History of Changes
Other Study ID Numbers: 07030836, BB-IND# 12452
Study First Received: January 11, 2008
Last Updated: September 15, 2011
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

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
 Pathologic Processes
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 22, 2013