Anti-IL-5 Therapy With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery for CRSwNP

Summary

This study compares two surgical approaches combined with anti-IL-5 therapy in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Patients will be randomly assigned to one of the three groups: (1) anti-IL-5 alone, (2) anti-IL-5 with simple polyp removal, or (3) anti-IL-5 with extended sinus surgery. The aim of this study is to see if a less invasive surgery (simple polyp removal) with anti-IL-5 works as well as more extensive surgery with anti-IL-5. Participants will be followed for 1 to 3 years.

Timeline

Start

2025-10-08

Primary completion

2029-10-10

Completion

2031-10-10

Publications

• Background Subspecialty Group of Rhinology, Editorial Board of Chinese Journal of Otorhinolaryngology Head and Neck Surgery; Subspecialty Group of Rhinology, Society of Otorhinolaryngology Head and Neck Surgery, Chinese Medical Association. [Guideline for diagnosis and treatment of chronic rhinosinusitis (2024)]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2025 Mar 7;60(3):221-249. doi: 10.3760/cma.j.cn115330-20250116-00051. No abstract available. Chinese.
• Background Han JK, Bachert C, Fokkens W, Desrosiers M, Wagenmann M, Lee SE, Smith SG, Martin N, Mayer B, Yancey SW, Sousa AR, Chan R, Hopkins C; SYNAPSE study investigators. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021 Oct;9(10):1141-1153. doi: 10.1016/S2213-2600(21)00097-7. Epub 2021 Apr 16.
• Background Homoe AS, Aanaes K, Tidemandsen JE, Holbaek HC, Niclas R, Badsberg SG, Holmegaard LBI, Backer V. Superior Benefits of Combining Mepolizumab With Sinus Surgery Compared to Mepolizumab Alone: Results From a Randomised 6-Month Trial. Int Forum Allergy Rhinol. 2025 Jul;15(7):724-733. doi: 10.1002/alr.23562. Epub 2025 Mar 10.
• Background Maza-Solano J, Callejon-Leblic A, Martin-Jimenez D, Moreno-Luna R, Gonzalez-Garcia J, Cuvillo A, Sanchez-Gomez S. Omalizumab Treatment in Uncontrolled Asthma and CRSwNP Patients, with Previous Endoscopic Sinus Surgery, to Improve Quality of Life and Endoscopic Outcomes: a Two-Year Real-Life Study. Curr Allergy Asthma Rep. 2023 Oct;23(10):555-566. doi: 10.1007/s11882-023-01106-w. Epub 2023 Aug 30.
• Background Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.
• Background Xian M, Yan B, Song X, Chen J, Tang J, Jiang Y, Wan L, Liu W, Xue J, Cao Z, Yu Y, Yang X, Shi L, Wang G, Xu Y, Yang Y, Ye J, Jiang L, Quan F, Tan G, Liu F, Xu Z, Zhang X, Li J, Su L, Yang Y, Fan J, He G, Zhu L, Wang X, Wang M, Shen S, Li J, Li H, Wei X, Yu H, Liu Z, Ma R, Liu H, Liu J, Lv W, Yang Q, Zhu D, Cheng L, Wang C, Zhang L. Chinese Position Paper on Biologic Therapy for Chronic Rhinosinusitis With Nasal Polyps. Allergy. 2025 May;80(5):1208-1225. doi: 10.1111/all.16519. Epub 2025 Mar 5.

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