Back to resultsEffects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis
Primary Purpose
Chronic Sinusitis
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Placebo
Xolair
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Sinusitis focused on measuring Chronic sinusitis, Xolair, Nasal Discharge, Nasal Obstruction, Facial Pain, Hyposmia
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
A
B
Arm Description
Subjects to receive placebo treatment for 6 months
Subjects to receive Xolair treatment for 6 months
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00603785
First Posted
January 11, 2008
Last Updated
January 30, 2020
Sponsor
University of California, San Francisco
Collaborators
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00603785
Brief Title
Effects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis
Official Title
Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient funds available
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2008 (Anticipated)
Study Completion Date
April 2008 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
Keywords
Chronic sinusitis, Xolair, Nasal Discharge, Nasal Obstruction, Facial Pain, Hyposmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Subjects to receive placebo treatment for 6 months
Arm Title
B
Arm Type
Experimental
Arm Description
Subjects to receive Xolair treatment for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Xolair
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Goldberg, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis
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