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

NCT00603785 | Withdrawn Phase 4

• 2 other identifiers: 07030836BB-IND# 12452
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Sinusitis

Keywords

Chronic sinusitis; Xolair; Nasal Discharge; Nasal Obstruction; Facial Pain; Hyposmia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

A

PLACEBO COMPARATOR

Subjects to receive placebo treatment for 6 months

Drug: Placebo

B

EXPERIMENTAL

Subjects to receive Xolair treatment for 6 months

Drug: Xolair

Interventions

Placebo DRUG

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.

A

Xolair DRUG

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.

B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Chicago: collaborator

MeSH Terms

Conditions

Rhinitis; Nasal Obstruction; Facial Pain; Anosmia

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Olfaction Disorders; Sensation Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Andrew Goldberg, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 29, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 5, 2020

Record last verified: 2020-01