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

WithdrawnPhase 4NCT00603785
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test
Conditions
  • Chronic Sinusitis
Interventions
Sponsor
University of California, San Francisco
Collaborators
University of Chicago
Start date
2008-01
Primary completion
2008-04
Sex
All
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00603785