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

Chronic Sinusitis Clinical Trial

Official title:

Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00603785
• Other study ID #: 07030836
• Secondary ID: BB-IND# 12452
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2008
• Est. completion date: April 2008

Study information

• Verified date: January 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	University of Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		At entry and every 4 weeks