Effects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis
Information source: University of California, San Francisco
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Sinusitis
Intervention: Placebo (Drug); Xolair (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
Andrew Goldberg, MD, Principal Investigator, Affiliation: University of California, San Francisco
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.
Clinical Details
Official title: Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: January 2008
Ending date: April 2008
Last updated: April 16, 2008
|
