MepolizumabSimple PolypectomyExtended Endoscopic Sinus Surgery
Mepolizumab: Subcutaneous injection of mepolizumab is administered every 4 weeks for a total treatment duration of 24 weeks.
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.
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Endoscopy shows bilateral nasal polyps, with bilateral NPS ≥4 (≥2 per side)
2. Nasal obstruction symptoms \>3 months, nasal obstruction score ≥2 (total 3 points) and/or hyposmia ≥2 (maximum 3 points)
3. 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
4. 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
Exclusion Criteria:
1. Cystic fibrosis, Young's syndrome, Kartagener syndrome, antrochoanal polyp, or rhinitis medicamentosa
2. Acute upper respiratory infection within 2 weeks
3. Asthma exacerbation within 1 month
4. HIV infection
5. Parasitic infection within 6 months
6. History of hypersensitivity to investigational drugs (except aspirin intolerance)
7. Hypersensitivity to monoclonal antibodies or anti-IL-5 agents
8. Oral steroid therapy within 1 month
9. Pregnancy planning, current pregnancy, or lactation
10. Uncontrolled systemic diseases
11. Have a history of previous sinus surgery for CRSwNP
12. Significant septal deviation affecting unilateral ventilation (mild deviation allowed)
13. Investigator judgment of unsuitability for cohort study
Primary outcome measure(s)
The Change in SNOT-22 Score — Baseline,Month12 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.
Change in Nasal Congestion Score — Baseline, Month 12 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.
Trial sites (17)
Facility
City
Region
Status
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Chongqing Municipality
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Fujian
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Longgang District Central Hospital of Shenzhen
Shenzhen
Guangdong
The First Affiliated Hospital of Harbin Medical University
Harbin
Heilongjiang
The Second Hospital of Harbin Medical University
Harbin
Heilongjiang
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Renmin hospital of Wuhan University
Wuhan
Hubei
The First Affiliated Hospital with Nanjing Medical University
Nanjing
Jiangsu
China-Japan Union Hospital of Jilin University
Changchun
Jilin
The Affiliated Hospital of Qingdao University
Qingdao
Shandong
Eye & ENT Hospital of Fudan University
Shanghai
Shanghai Municipality
Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai
Shanghai Municipality
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
The Second Hospital of Shanxi Medical University
Taiyuan
Shanxi
The Affiliated Hospital of Yunnan University
Kunming
Yunnan
Affiliated Hangzhou First People's Hospital,School of Medicine, Westlake University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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