Xolair in Patients With Chronic Sinusitis

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.

Timeline

Start

2005-07

Primary completion

2007-05

Completion

2009-01

Publications

• Background Benninger MS, Senior BA. The development of the Rhinosinusitis Disability Index. Arch Otolaryngol Head Neck Surg. 1997 Nov;123(11):1175-9. doi: 10.1001/archotol.1997.01900110025004.
• Background 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. doi: 10.1067/mhn.2002.121022.
• Background 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. doi: 10.1067/mai.2001.117880.
• Background 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. doi: 10.1183/09031936.01.00092101.
• Background 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. doi: 10.1177/019459989110400409.
• Background 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. doi: 10.1001/archotol.1997.01900060044007.
• Background 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.
• Background 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.
• Background Hamilos DL. Chronic sinusitis. J Allergy Clin Immunol. 2000 Aug;106(2):213-27. doi: 10.1067/mai.2000.109269.
• Background Iwens P, Clement PA. Sinusitis in allergic patients. Rhinology. 1994 Jun;32(2):65-7.
• Background Binder E, Holopainen E, Malmberg H, Salo OP. Clinical findings in patients with allergic rhinitis. Rhinology. 1984 Dec;22(4):255-60.
• Background 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. doi: 10.1016/0091-6749(78)90052-0. No abstract available.
• Background 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.
• Background 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.
• Background VAN DISHOECK HA, FRANSSEN MG. The incidence and correlation of allergy and chronic maxillary sinusitis. Pract Otorhinolaryngol (Basel). 1957 Nov;19(6):502-6. doi: 10.1159/000274105. No abstract available.
• Background Friedman WH. Surgery for chronic hyperplastic rhinosinusitis. Laryngoscope. 1975 Dec;85(12 pt 1):1999-2011. doi: 10.1288/00005537-197512000-00005.
• Background Enberg RN. Perennial nonallergic rhinitis: a retrospective review. Ann Allergy. 1989 Dec;63(6 Pt 1):513-6.
• Background 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.
• Background 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. doi: 10.1016/0091-6749(77)90171-3.
• Background 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. doi: 10.1016/s1081-1206(10)63180-8.
• Background 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. doi: 10.1001/archotol.124.5.513.
• Background Karlsson G, Holmberg K. Does allergic rhinitis predispose to sinusitis? Acta Otolaryngol Suppl. 1994;515:26-8; discussion 29. doi: 10.3109/00016489409124319.
• Background 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. doi: 10.1001/archotol.1996.01890230055011.
• 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. doi: 10.4193/Rhino09.144.

Drugs

Indications