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Clinical Trials in Japan / NCT07200336
Starting soon Phase 4

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

NCT07200336 · tracked via the Priya Life Science Japan tracker
Sponsor
Eye & ENT Hospital of Fudan University
Phase
Phase 4
Started
2025-10-08
Last updated
2025-10-01

Condition(s) studied

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Investigational drug(s) / intervention(s)

Mepolizumab →Simple 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)

FacilityCityRegionStatus
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 Hangzhou Zhejiang

On this site

📄 Nucala (mepolizumab) drug profile →

Other trials for the same condition

A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP) Recruiting
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps Recruiting
Official registry record

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.

View NCT07200336 on ClinicalTrials.gov ↗ ← All trials in Japan