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Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Phase 4NCT07200336

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

A Phase 4 study testing Mepolizumab, Simple Polypectomy and Extended Endoscopic Sinus Surgery in people with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Eye & ENT Hospital of Fudan University at 17 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Mepolizumab, Simple Polypectomy and Extended Endoscopic Sinus Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
17 sitesChina
Study dates
8 Oct 2025to 10 Oct 2031
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Huabin Li, PhD contact

86-18816993402

allergyli@163.com

Hongfei Lou, PhD contact

86-15210295496

allerylhf@163.com

17 sites in 1 country

China17 sites

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033

    Cuida Meng, MD, 86-13596096000, mengcd@jlu.edu.cn

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Yucheng Yang, MD, 86-13452018123, yychxh@163.com

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

    Qinghua Liu, MD, 86-15280096007, 15280096007@163.com

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

    Fenghong Chen, MD, 86-13560170816, chen_fenghong@163.com

  • Affiliated Hangzhou First People's Hospital,School of Medicine, Westlake University

    Hangzhou, Zhejiang, 310006

    Yong Li, MD, 86-13858084222, leeyung828@hotmail.com

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Tianhong Zhang, MD, 86-13945073856, zth3856@126.com

  • The Second Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

    Yanan Sun, MD, 86-13633631706, 76202920@qq.com

  • The Affiliated Hospital of Yunnan University

    Kunming, Yunnan, 650000

    Yanli Yang, PhD, 86-18651602696, xyang895@126.com

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Meiping Lu, PhD, 86-13776683366, lumeiping@jsph.org.cn

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

    Yan Jiang, MD, 86-13256875886, jiangyanoto@163.com

  • Eye & ENT Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200031

    Huabin Li, PhD, 86-18816993402, allergyli@163.com

  • Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

    Shanghai, Shanghai Municipality, 200052

    Na Sun, MD, 86-13917998216, sunnsh-2007@163.com

  • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200233

    Weitian Zhang, MD, 86-18930177043, drzhangwt@163.com

  • Longgang District Central Hospital of Shenzhen

    Shenzhen, Guangdong, 518000

    Gui Yang, PhD, 86-13510646616, 303630898@qq.com

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Yunfang An, PhD, 86-13834236996, ayfent@126.com

  • Renmin hospital of Wuhan University

    Wuhan, Hubei, 430060

    Yu Xu, MD, 86-15927088198, xy37138@163.com

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Ying Wang, MD, 86-13526477216, bike2202@163.com

Other trials in China

About this study

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

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.

Being tested
Mepolizumab, Simple Polypectomy, Extended Endoscopic Sinus Surgery
Keywords
Anti-IL-5, Biologic-Surgical Combination, Extended Sinus Surgery, SNOT-22, Type 2 Inflammation, Recurrence
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MepolizumabDrug

    Subcutaneous injection of mepolizumab is administered every 4 weeks for a total treatment duration of 24 weeks.

  • Simple PolypectomyProcedure or surgery

    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.

  • Extended Endoscopic Sinus SurgeryProcedure or 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.
Study groups in NCT07200336
Study groupRoleWhat they receive
Anti-IL-5 MonotherapyExperimentalMepolizumab 100mg subcutaneously every 4 weeks for 24 weeks
Receives: Drug: Mepolizumab
Anti-IL-5 + Simple PolypectomyExperimentalCombined 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.
Receives: Drug: Mepolizumab; Procedure: Simple Polypectomy
Anti-IL-5 + Extended Endoscopic Sinus SurgeryExperimentalCombined 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.
Receives: Drug: Mepolizumab; Procedure: Extended Endoscopic Sinus Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline,Month12

  2. 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.

    Measured: Baseline, Month 12

Secondary outcomes (10)

  1. 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.

    Measured: Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,24,36 month after biological treatment initiation

  2. 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.

    Measured: Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,24,36 month after biological treatment initiation

  3. 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.

    1. Small polyps in the middle meatus.
    2. Polyps in the middle meatus reaching below the inferior border of the middle turbinate.
    3. Large polyps reaching beyond the inferior border of the middle turbinate or with medial extension from the middle turbinate.
    4. Polyps completely obstructing the nasal cavity.

    Measured: 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

  4. 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.

    Measured: 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

  5. Change in Blood Eosinophil percentage

    Measured: 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

  6. 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.

    Measured: Baseline, at 6,12, 24,36 month after biological treatment

  7. 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.

    Measured: 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

  8. Change in FeNO and nNO

    Measured: Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 3,6,12,24,36 month after first biological treatment

  9. Need for Systemic Corticosteroid

    Measured: 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation

  10. 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).

    Measured: Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 3,6,12,24,36 month after biological treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2025
  2. Study start8 Oct 2025 (estimated)
  3. Primary completion10 Oct 2029 (estimated)
  4. Study completion10 Oct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07200336
Sponsor's protocol ID
NPESS-2025
Status last verified
Sep 2025
First submitted
13 Sep 2025
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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, 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.

    PubMed 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 Rhinosinusitis With Nasal Polyps. Allergy. 2025 May;80(5):1208-1225. doi: 10.1111/all.16519. Epub 2025 Mar 5.

    PubMed 40042059

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mepolizumab, Simple Polypectomy and Extended Endoscopic Sinus Surgery in people with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Eye & ENT Hospital of Fudan University at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huabin Li, PhD (86-18816993402, allergyli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change in SNOT-22 Score (time frame: Baseline,Month12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07200336, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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