Xolair in Patients With Chronic Sinusitis - Full Text View

Sponsor:	University of Chicago
Collaborators:	Genentech Novartis
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00117611

Purpose

The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.

Condition	Intervention	Phase
Sinusitis	Drug: Anti-IgE antibody omalizumab or placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis

Drug Information available for: Omalizumab Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Mucosal thickness on CT scan [ Time Frame: after 6 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rhinosinusitis Disability Index (RSDI)recorded monthly [ Time Frame: 6 months ] [ Designated as safety issue: No ]
A specific quality of life (QOL) measure, Sino-Nasal Outcome Test (SNOT 20)recorded monthly [ Time Frame: 6 months ] [ Designated as safety issue: No ]
A general health QOL measure (SF-36) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The number of sinusitis exacerbations requiring additional treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Nasal peak inspiratory flow [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Symptoms of nasal discharge, nasal obstruction, facial pain and altered smell [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Nasal lavage eosinophils [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Nasal endoscopy score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Xolair administered subcutaneously, once or twice monthly (dose dependent on subject weight and serum IgE level)	Drug: Anti-IgE antibody omalizumab or placebo given subcutaneously oce or twice monthly depending on dose Other Name: Xolair or placebo
Placebo Comparator: 2 placebo administered subcutaneously once or twice monthly	Drug: Anti-IgE antibody omalizumab or placebo given subcutaneously oce or twice monthly depending on dose Other Name: Xolair or placebo

Detailed Description:

At its most basic level, sinusitis is defined as an inflammation of the lining membrane of the paranasal sinuses. Sinusitis affects all age groups, including 17% of people above the age of 65 years. On the basis of national population surveys and insurance-reimbursement claims, sinusitis is one of the most common health problems in the U.S. Thus, each year, billions of dollars are spent on direct medical costs for the treatment of this enigmatic illness.

Despite the enormous cost of the problem, there are no definite studies of treatment and management. There are some data indicating that intranasal steroids are effective, and recently Nasonex was approved for the treatment of nasal polyps. All other treatments are empirically based.

There is evidence that IgE antibodies play a role in chronic sinusitis. The investigators have shown that total IgE levels correlate with the severity of sinusitis, as assessed by CT scan. Staphylococcus enterotoxins cause local increases in total IgE in over 50% of nasal polyp patients. Allergies occur more frequently in patients with chronic sinusitis than in the general population. Elevations in total IgE have been shown to occur in patients with allergic fungal sinusitis and the levels of total IgE decrease with successful treatment. Thus, the investigators speculate that IgE contributes significantly to the pathogenesis of chronic sinusitis.

The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair, will improve objective and subjective evidence of chronic sinusitis.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 150 kg
Impaired quality of life, as measured by the Rhinosinusitis Disability Index (RSDI)

Exclusion Criteria:

Women of childbearing potential not using a 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 condition(s) that, in the opinion 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117611

Locations

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Genentech

Novartis

Investigators

Principal Investigator:

Robert M Naclerio, MD

University of Chicago

More Information

Publications:

Benninger MS, Senior BA. The development of the Rhinosinusitis Disability Index. Arch Otolaryngol Head Neck Surg. 1997 Nov;123(11):1175-9.

Piccirillo JF, Merritt MG Jr, Richards ML. Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg. 2002 Jan;126(1):41-7.

Busse W, Corren J, Lanier BQ, McAlary M, Fowler-Taylor A, Cioppa GD, van As A, Gupta N. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001 Aug;108(2):184-90.

Soler M, Matz J, Townley R, Buhl R, O'Brien J, Fox H, Thirlwell J, Gupta N, Della Cioppa G. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001 Aug;18(2):254-61. Erratum in: Eur Respir J 2001 Oct;18(4):739-40.

Calhoun KH, Waggenspack GA, Simpson CB, Hokanson JA, Bailey BJ. CT evaluation of the paranasal sinuses in symptomatic and asymptomatic populations. Otolaryngol Head Neck Surg. 1991 Apr;104(4):480-3.

Iwabuchi Y, Hanamure Y, Ueno K, Fukuda K, Furuta S. Clinical significance of asymptomatic sinus abnormalities on magnetic resonance imaging. Arch Otolaryngol Head Neck Surg. 1997 Jun;123(6):602-4.

McCaig LF, Hughes JM. Trends in antimicrobial drug prescribing among office-based physicians in the United States. JAMA. 1995 Jan 18;273(3):214-9. Erratum in: JAMA 1998 Feb 11;279(6):434.

Kaliner MA, Osguthorpe JD, Fireman P, Anon J, Georgitis J, Davis ML, Naclerio R, Kennedy D. Sinusitis: bench to bedside. Current findings, future directions. Otolaryngol Head Neck Surg. 1997 Jun;116(6 Pt 2):S1-20. Review. Erratum in: Otolaryngol Head Neck Surg 1997 Sep;117(3 Pt 1):187.

Hamilos DL. Chronic sinusitis. J Allergy Clin Immunol. 2000 Aug;106(2):213-27. Review.

Iwens P, Clement PA. Sinusitis in allergic patients. Rhinology. 1994 Jun;32(2):65-7.

Binder E, Holopainen E, Malmberg H, Salo OP. Clinical findings in patients with allergic rhinitis. Rhinology. 1984 Dec;22(4):255-60.

Rachelefsky GS, Goldberg M, Katz RM, Boris G, Gyepes MT, Shapiro MJ, Mickey MR, Finegold SM, Siegel SC. Sinus disease in children with respiratory allergy. J Allergy Clin Immunol. 1978 May;61(5):310-4. No abstract available.

Holzmann D, Willi U, Nadal D. Allergic rhinitis as a risk factor for orbital complication of acute rhinosinusitis in children. Am J Rhinol. 2001 Nov-Dec;15(6):387-90.

Chen CF, Wu KG, Hsu MC, Tang RB. Prevalence and relationship between allergic diseases and infectious diseases. J Microbiol Immunol Infect. 2001 Mar;34(1):57-62.

VAN DISHOECK HA, FRANSSEN MG. The incidence and correlation of allergy and chronic maxillary sinusitis. Pract Otorhinolaryngol (Basel). 1957 Nov;19(6):502-6. No abstract available.

Friedman WH. Surgery for chronic hyperplastic rhinosinusitis. Laryngoscope. 1975 Dec;85(12 pt 1):1999-2011.

Enberg RN. Perennial nonallergic rhinitis: a retrospective review. Ann Allergy. 1989 Dec;63(6 Pt 1):513-6.

Conner BL, Roach ES, Laster W, Georgitis JW. Magnetic resonance imaging of the paranasal sinuses: frequency and type of abnormalities. Ann Allergy. 1989 May;62(5):457-60.

Settipane GA, Chafee FH. Nasal polyps in asthma and rhinitis. A review of 6,037 patients. J Allergy Clin Immunol. 1977 Jan;59(1):17-21.

Holmberg K, Juliusson S, Balder B, Smith DL, Richards DH, Karlsson G. Fluticasone propionate aqueous nasal spray in the treatment of nasal polyposis. Ann Allergy Asthma Immunol. 1997 Mar;78(3):270-6.

Lund VJ, Flood J, Sykes AP, Richards DH. Effect of fluticasone in severe polyposis. Arch Otolaryngol Head Neck Surg. 1998 May;124(5):513-8.

Karlsson G, Holmberg K. Does allergic rhinitis predispose to sinusitis? Acta Otolaryngol Suppl. 1994;515:26-8; discussion 29. Review.

Kingdom TT, Lee KC, FitzSimmons SC, Cropp GJ. Clinical characteristics and genotype analysis of patients with cystic fibrosis and nasal polyposis requiring surgery. Arch Otolaryngol Head Neck Surg. 1996 Nov;122(11):1209-13.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pinto JM, Mehta N, DiTineo M, Wang J, Baroody FM, Naclerio RM. A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis. Rhinology. 2010 Sep;48(3):318-24.

Responsible Party:	Robert Naclerio, MD, University of Chicago
ClinicalTrials.gov Identifier:	NCT00117611 History of Changes
Other Study ID Numbers:	13916A, Q2347s
Study First Received:	June 30, 2005
Last Updated:	July 16, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

chronic sinusitis

Additional relevant MeSH terms:

Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes

Antibodies
Omalizumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Allergic Agents
Therapeutic Uses
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012