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

NCT07200336 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-10-01

No results posted yet for this 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.

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Interventions

DRUG

Mepolizumab

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

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Huabin Li, PhD · Eye & ENT Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-08
Primary Completion
2029-10-10
Completion
2031-10-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07200336 on ClinicalTrials.gov