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

Официальное название

Efficacy of Anti-IL-5 Therapy Combined With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery in Patients With CRSwNP: A Multicenter Randomized Controlled Trial

Обзор

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.

Вмешательства

• Препарат Mepolizumab
  Subcutaneous injection of mepolizumab is administered every 4 weeks for a total treatment duration of 24 weeks.
• Процедура Simple Polypectomy
  Removal of nasal polyps in the middle meatus and superior turbinate region via the middle meatus and olfactory cleft, without opening the involved sinuses and without resection of diseased bone.
• Процедура Extended Endoscopic Sinus Surgery
  1. Complete opening of all sinuses 2. Resection of diseased mucosa and hyperplastic bone 3. Ethmoid skeletonization with middle turbinectomy 4. Draf IIb/III frontal dissection when indicated by CT severity.

Первичные конечные точки

• The Change in SNOT-22 Score [Срок оценки: Baseline,Month12]
• Change in Nasal Congestion Score [Срок оценки: Baseline, Month 12]

Вторичные конечные точки (10)

• Change in SNOT-22 Score [Срок оценки: Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,24,36 month after biological treatment initiation]
• Change in Nasal Congestion Score [Срок оценки: Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,24,36 month after biological treatment initiation]
• Change in Nasal Polyp Score (NPS) [Срок оценки: Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation]
• Change in Modified Lund-Kennedy Score [Срок оценки: Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation]
• Change in Blood Eosinophil percentage [Срок оценки: Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation]
• Change in Lund-Mackay CT Score [Срок оценки: Baseline, at 6,12, 24,36 month after biological treatment]
• Change in Olfactory Function [Срок оценки: Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation]
• Change in FeNO and nNO [Срок оценки: Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 3,6,12,24,36 month after first biological treatment]
• Need for Systemic Corticosteroid [Срок оценки: 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation]
• Objective Olfactory function Test [Срок оценки: Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 3,6,12,24,36 month after biological treatment initiation]

Критерии участия

Критерии включения

• Endoscopy shows bilateral nasal polyps, with bilateral NPS ≥4 (≥2 per side)
• Nasal obstruction symptoms >3 months, nasal obstruction score ≥2 (total 3 points) and/or hyposmia ≥2 (maximum 3 points)
• Evidence of type 2 inflammation: Nasal polyp tissue Eos >55/HPF or >27% of inflammatory cells; or Peripheral blood Eos ≥6.9% (without asthma) or ≥3.7% (with asthma) Note: Meet any 2 of the above 3 criteria
• Failure after 4 weeks of standard medical therapy including: Intranasal corticosteroids >4 weeks; Other agents (oral steroids, macrolides, antihistamines, leukotriene receptor antagonists, decongestants, antibiotics) permitted as needed

Критерии исключения

• Cystic fibrosis, Young's syndrome, Kartagener syndrome, antrochoanal polyp, or rhinitis medicamentosa
• Acute upper respiratory infection within 2 weeks
• Asthma exacerbation within 1 month
• HIV infection
• Parasitic infection within 6 months
• History of hypersensitivity to investigational drugs (except aspirin intolerance)
• Hypersensitivity to monoclonal antibodies or anti-IL-5 agents
• Oral steroid therapy within 1 month
• Pregnancy planning, current pregnancy, or lactation
• Uncontrolled systemic diseases
• Have a history of previous sinus surgery for CRSwNP
• Significant septal deviation affecting unilateral ventilation (mild deviation allowed)
• Investigator judgment of unsuitability for cohort study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 17 центров

• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The First Affiliated Hospital of Fujian Medical University — Фучжоу
• The Second Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• Longgang District Central Hospital of Shenzhen — Шэньчжэнь
• The First Affiliated Hospital of Harbin Medical University — Харбин
• The Second Hospital of Harbin Medical University — Харбин
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• Renmin hospital of Wuhan University — Ухань
• … и ещё 9 центров

Публикации

• 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.cn11 PMID 40147886
• 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. PMID 33872587
• 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. PMID 40065601
• 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. PMID 37644255
• 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, M PMID 32077450
• 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 Rhinosinusi PMID 40042059

Идентификаторы

NCT: NCT07200336 · NPESS-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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