Dupilumab for Aspirin-exacerbated Respiratory Disease

Summary

Subjects with physician-diagnosed aspirin-exacerbated respiratory disease (AERD) who remain unacceptably symptomatic with a SNOT 22 score \> 18 despite routine medical therapy will be enrolled in this single center, single-blinded study assessing the efficacy of dupilumab in AERD.

Timeline

Start

2018-09-05

Primary completion

2019-12-11

Completion

2019-12-11

Publications

• Background Rajan JP, Wineinger NE, Stevenson DD, White AA. Prevalence of aspirin-exacerbated respiratory disease among asthmatic patients: A meta-analysis of the literature. J Allergy Clin Immunol. 2015 Mar;135(3):676-81.e1. doi: 10.1016/j.jaci.2014.08.020. Epub 2014 Oct 3.
• Background Mullol J, Picado C. Rhinosinusitis and nasal polyps in aspirin-exacerbated respiratory disease. Immunol Allergy Clin North Am. 2013 May;33(2):163-76. doi: 10.1016/j.iac.2012.11.002. Epub 2012 Dec 23.
• Background Ta V, White AA. Survey-Defined Patient Experiences With Aspirin-Exacerbated Respiratory Disease. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):711-8. doi: 10.1016/j.jaip.2015.03.001. Epub 2015 Apr 7.
• Background Berges-Gimeno MP, Simon RA, Stevenson DD. Long-term treatment with aspirin desensitization in asthmatic patients with aspirin-exacerbated respiratory disease. J Allergy Clin Immunol. 2003 Jan;111(1):180-6. doi: 10.1067/mai.2003.7.
• Background Stevenson DD, Pleskow WW, Simon RA, Mathison DA, Lumry WR, Schatz M, Zeiger RS. Aspirin-sensitive rhinosinusitis asthma: a double-blind crossover study of treatment with aspirin. J Allergy Clin Immunol. 1984 Apr;73(4):500-7. doi: 10.1016/0091-6749(84)90361-0.
• Background Swierczynska-Krepa M, Sanak M, Bochenek G, Strek P, Cmiel A, Gielicz A, Plutecka H, Szczeklik A, Nizankowska-Mogilnicka E. Aspirin desensitization in patients with aspirin-induced and aspirin-tolerant asthma: a double-blind study. J Allergy Clin Immunol. 2014 Oct;134(4):883-90. doi: 10.1016/j.jaci.2014.02.041. Epub 2014 Apr 24.
• Background Fruth K, Pogorzelski B, Schmidtmann I, Springer J, Fennan N, Fraessdorf N, Boessert A, Schaefer D, Gosepath J, Mann WJ. Low-dose aspirin desensitization in individuals with aspirin-exacerbated respiratory disease. Allergy. 2013;68(5):659-65. doi: 10.1111/all.12131. Epub 2013 Mar 7.
• Background Esmaeilzadeh H, Nabavi M, Aryan Z, Arshi S, Bemanian MH, Fallahpour M, Mortazavi N. Aspirin desensitization for patients with aspirin-exacerbated respiratory disease: A randomized double-blind placebo-controlled trial. Clin Immunol. 2015 Oct;160(2):349-57. doi: 10.1016/j.clim.2015.05.012. Epub 2015 Jun 14.
• Background Waldram JD, White AA. A survey of aspirin desensitization practices among allergists and fellows in training in the United States. J Allergy Clin Immunol Pract. 2016 Nov-Dec;4(6):1253-1255. doi: 10.1016/j.jaip.2016.06.016. Epub 2016 Jul 21. No abstract available.
• Background Samuelsson B, Dahlen SE, Lindgren JA, Rouzer CA, Serhan CN. Leukotrienes and lipoxins: structures, biosynthesis, and biological effects. Science. 1987 Sep 4;237(4819):1171-6. doi: 10.1126/science.2820055.
• Background Laidlaw TM, Boyce JA. Aspirin-Exacerbated Respiratory Disease--New Prime Suspects. N Engl J Med. 2016 Feb 4;374(5):484-8. doi: 10.1056/NEJMcibr1514013. No abstract available.
• Background Bachert C, Zhang N. Chronic rhinosinusitis and asthma: novel understanding of the role of IgE 'above atopy'. J Intern Med. 2012 Aug;272(2):133-43. doi: 10.1111/j.1365-2796.2012.02559.x.
• Background Patou J, Gevaert P, Van Zele T, Holtappels G, van Cauwenberge P, Bachert C. Staphylococcus aureus enterotoxin B, protein A, and lipoteichoic acid stimulations in nasal polyps. J Allergy Clin Immunol. 2008 Jan;121(1):110-5. doi: 10.1016/j.jaci.2007.08.059. Epub 2007 Nov 5.
• Background Wenzel S, Ford L, Pearlman D, Spector S, Sher L, Skobieranda F, Wang L, Kirkesseli S, Rocklin R, Bock B, Hamilton J, Ming JE, Radin A, Stahl N, Yancopoulos GD, Graham N, Pirozzi G. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013 Jun 27;368(26):2455-66. doi: 10.1056/NEJMoa1304048. Epub 2013 May 21.
• Background Wenzel S, Castro M, Corren J, Maspero J, Wang L, Zhang B, Pirozzi G, Sutherland ER, Evans RR, Joish VN, Eckert L, Graham NM, Stahl N, Yancopoulos GD, Louis-Tisserand M, Teper A. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting beta2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016 Jul 2;388(10039):31-44. doi: 10.1016/S0140-6736(16)30307-5. Epub 2016 Apr 27.
• Background Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.
• Background Doty RL, Shaman P, Dann M. Development of the University of Pennsylvania Smell Identification Test: a standardized microencapsulated test of olfactory function. Physiol Behav. 1984 Mar;32(3):489-502. doi: 10.1016/0031-9384(84)90269-5.
• Background Lund VJ, Kennedy DW. Staging for rhinosinusitis. Otolaryngol Head Neck Surg. 1997 Sep;117(3 Pt 2):S35-40. doi: 10.1016/S0194-59989770005-6.
• Background Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
• Background Juniper EF, Buist AS, Cox FM, Ferrie PJ, King DR. Validation of a standardized version of the Asthma Quality of Life Questionnaire. Chest. 1999 May;115(5):1265-70. doi: 10.1378/chest.115.5.1265.
• Background Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
• Background Gillett S, Hopkins C, Slack R, Browne JP. A pilot study of the SNOT 22 score in adults with no sinonasal disease. Clin Otolaryngol. 2009 Oct;34(5):467-9. doi: 10.1111/j.1749-4486.2009.01975.x.
• Background Lange B, Thilsing T, Baelum J, Kjeldsen AD. The Sinonasal Outcome Test 22 score in persons without chronic rhinosinusitis. Clin Otolaryngol. 2016 Apr;41(2):127-30. doi: 10.1111/coa.12481. Epub 2016 Feb 4.
• Background Sommer DD, Hoffbauer S, Au M, Sowerby LJ, Gupta MK, Nayan S. Treatment of aspirin exacerbated respiratory disease with a low salicylate diet: a pilot crossover study. Otolaryngol Head Neck Surg. 2015 Jan;152(1):42-7. doi: 10.1177/0194599814555836. Epub 2014 Oct 24.
• Background Sommer DD, Rotenberg BW, Sowerby LJ, Lee JM, Janjua A, Witterick IJ, Monteiro E, Gupta MK, Au M, Nayan S. A novel treatment adjunct for aspirin exacerbated respiratory disease: the low-salicylate diet: a multicenter randomized control crossover trial. Int Forum Allergy Rhinol. 2016 Apr;6(4):385-91. doi: 10.1002/alr.21678. Epub 2016 Jan 11.
• Background Cho KS, Soudry E, Psaltis AJ, Nadeau KC, McGhee SA, Nayak JV, Hwang PH. Long-term sinonasal outcomes of aspirin desensitization in aspirin exacerbated respiratory disease. Otolaryngol Head Neck Surg. 2014 Oct;151(4):575-81. doi: 10.1177/0194599814545750. Epub 2014 Aug 12.
• Background Bachert C, Mannent L, Naclerio RM, Mullol J, Ferguson BJ, Gevaert P, Hellings P, Jiao L, Wang L, Evans RR, Pirozzi G, Graham NM, Swanson B, Hamilton JD, Radin A, Gandhi NA, Stahl N, Yancopoulos GD, Sutherland ER. Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial. JAMA. 2016 Feb 2;315(5):469-79. doi: 10.1001/jama.2015.19330.

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Indications