Xolair in Patients With Chronic Sinusitis

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: Completed

Administrative data

• NCT number: NCT00117611
• Other study ID #: 13916A
• Secondary ID: Q2347s
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2005
• Last updated: September 27, 2013
• Start date: July 2005
• Est. completion date: January 2009

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2009
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Sinusitis

Intervention

Drug:
• Anti-IgE antibody omalizumab or placebo
given subcutaneously oce or twice monthly depending on dose

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	Genentech, Inc., Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (23)

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Solèr 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. — View Citation

VAN DISHOECK HA, FRANSSEN MG. The incidence and correlation of allergy and chronic maxillary sinusitis. Pract Otorhinolaryngol (Basel). 1957 Nov;19(6):502-6. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucosal thickness on CT scan		after 6 months of treatment	No
Secondary	Rhinosinusitis Disability Index (RSDI)recorded monthly		6 months	No
Secondary	A specific quality of life (QOL) measure, Sino-Nasal Outcome Test (SNOT 20)recorded monthly		6 months	No
Secondary	A general health QOL measure (SF-36)		6 months	No
Secondary	The number of sinusitis exacerbations requiring additional treatment		6 months	No
Secondary	Nasal peak inspiratory flow		6 months	No
Secondary	Symptoms of nasal discharge, nasal obstruction, facial pain and altered smell		6 months	No
Secondary	Nasal lavage eosinophils		6 months	No
Secondary	Nasal endoscopy score		6 months	No
Secondary	The University of Pennsylvania Smell Identification Test (UPSIT)		6 months	No