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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-IL-5 Monotherapy | Experimental | Mepolizumab 100mg subcutaneously every 4 weeks for 24 weeks |
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| Anti-IL-5 + Simple Polypectomy | Experimental | Combined therapy: A 100 mg dose of mepolizumab is initiated subcutaneously 2 weeks after simple polypectomy. Mepolizumab will be administered subcutaneously every 4 weeks for 24 weeks. |
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| Anti-IL-5 + Extended Endoscopic Sinus Surgery | Experimental | Combined therapy: A 100 mg dose of mepolizumab is initiated subcutaneously 2 weeks after Extended Endoscopic Sinus Surgery. Mepolizumab will be administered subcutaneously every 4 weeks for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab | Drug | Subcutaneous injection of mepolizumab is administered every 4 weeks for a total treatment duration of 24 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Change in SNOT-22 Score | The 22-item Sinonasal Outcome Test (SNOT-22) is a questionnaire comprising 22 questions on health-related quality of life in rhinosinusitis. For each item, patients provide a subjective rating on a scale from 0 to 5, where 0 represents "No problem" and 5 represents "Problem as bad as it can be." The total score is the sum of all items and ranges from a minimum of 0 to a maximum of 110. A higher total score indicates a worse outcome, reflecting a poorer quality of life due to rhinosinusitis. | Baseline,Month12 |
| Change in Nasal Congestion Score | The Nasal Congestion Score (NCS) is a patient-reported outcome measure that assesses the subjective severity of nasal congestion. The score ranges from a minimum of 0 to a maximum of 3, where 0 represents "No nasal congestion" and 3 represents "The most severe nasal congestion." A higher score indicates a worse outcome. | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SNOT-22 Score | The 22-item Sinonasal Outcome Test (SNOT-22) is a questionnaire comprising 22 questions on health-related quality of life in rhinosinusitis. For each item, patients provide a subjective rating on a scale from 0 to 5, where 0 represents "No problem" and 5 represents "Problem as bad as it can be." The total score is the sum of all items and ranges from a minimum of 0 to a maximum of 110. A higher total score indicates a worse outcome, reflecting a poorer quality of life due to rhinosinusitis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huabin Li, PhD | Contact | 86-18816993402 | allergyli@163.com | |
| Hongfei Lou, PhD | Contact | 86-15210295496 | allerylhf@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huabin Li, PhD | Eye & ENT Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40147886 | 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. | |
| 33872587 |
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| Simple Polypectomy | Procedure | 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. |
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| Extended Endoscopic Sinus Surgery | Procedure |
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| 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 | The Nasal Congestion Score (NCS) is a patient-reported outcome measure that assesses the subjective severity of nasal congestion. The score ranges from a minimum of 0 to a maximum of 3, where 0 represents "No nasal congestion" and 3 represents "The most severe nasal congestion." A higher score indicates a worse outcome. | 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) | The Nasal Polyp Score (NPS) is an objective assessment tool, evaluated by a clinician, used to grade the size of nasal polyps. Each nasal cavity is scored separately on a scale from 0 to 4. The total score is the sum of the scores from both nostrils and ranges from a minimum of 0 to a maximum of 8. A higher score indicates larger nasal polyps and a worse outcome. The scoring criteria are as follows: 0: No polyps.
| 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 | The modified Lund-Kennedy (MLK) score is an objective endoscopic evaluation performed by a clinician. A higher score indicates a worse outcome. It scores nasal polyps, edema, and discharge (0-2 for each) per nostril. The total score ranges from 0 to 12, with a higher score indicating worse endoscopic status. | 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 | 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 | The Lund-Mackay CT scoring system is an objective radiological assessment. It evaluates the extent of opacification on sinus computed tomography (CT) scans in six anatomical regions per side: anterior ethmoid sinuses, posterior ethmoid sinuses, maxillary sinuses, sphenoid sinuses, frontal sinuses, and the ostiomeatal complex. Each region is scored from 0 (no abnormality) to 2 (complete opacification). The total score, which is the sum of scores from all regions across both sides, ranges from a minimum of 0 to a maximum of 24. A higher total score indicates greater disease severity. | Baseline, at 6,12, 24,36 month after biological treatment |
| Change in Olfactory Function | We will provide patients with an olfactory questionnaire, asking them to respond to the following questions. Each question will have a corresponding score: 0 points for "strongly disagree," 1 point for "partially agree," 2 points for "incompletely agree," and 3 points for "strongly agree." The questions include: I feel my sense of smell has become much worse than before. Compared to before the onset of olfactory dysfunction, the taste of food has changed. Sometimes I can smell unpleasant odors that others cannot detect. Some pleasant smells that others enjoy are unpleasant to me. My biggest issue is that, compared to before the onset of olfactory dysfunction, smells are perceived differently. Due to changes in my sense of smell, I dine out less often than before. I worry that I will not be able to adapt to the changes in my sense of smell in the future. Due to changes in my sense of smell, I feel more anxious than before. Changes in my sense of smell often make me feel angry. | 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 | 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 | 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 | Olfactory function was evaluated by the Sniffin' Sticks test, containing olfactory threshold (T), discrimination (D) and identification (I) tests . Score for the threshold test range between 1 and 16, while the scores of the other two tests range between 0 and 16. The results of the three tests were calculated as a total TDI score (range 1- 48), which was used to define functional anosmia (TDI ≤ 16), hyposmia (16 < TDI < 31), or normosmia (TDI ≥ 31). If the patients had only been assessed by the identification test, the I score was used to define functional anosmia (I ≤ 8), hyposmia (8 < I ≤ 11), or 113 normosmia (I > 11). | Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 3,6,12,24,36 month after biological treatment initiation |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350005 | China |
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| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510000 | China |
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| Longgang District Central Hospital of Shenzhen | Shenzhen | Guangdong | 518000 | China |
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| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
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| The Second Hospital of Harbin Medical University | Harbin | Heilongjiang | 150086 | China |
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| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
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| Renmin hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
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| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
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| China-Japan Union Hospital of Jilin University | Changchun | Jilin | 130033 | China |
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| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
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| Eye & ENT Hospital of Fudan University | Shanghai | Shanghai Municipality | 200031 | China |
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| Guanghua Hospital of Integrated Traditional Chinese and Western Medicine | Shanghai | Shanghai Municipality | 200052 | China |
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| Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200233 | China |
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| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
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| The Affiliated Hospital of Yunnan University | Kunming | Yunnan | 650000 | China |
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| Affiliated Hangzhou First People's Hospital,School of Medicine, Westlake University | Hangzhou | Zhejiang | 310006 | China |
|
| 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. |
| 40065601 | 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. |
| 37644255 | 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. |
| 32077450 | 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. |
| 40042059 | 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. |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
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