NCT07200336

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-10-08
• Primary completion: 2029-10-10
• Completion: 2031-10-10
• First posted: 2025-10-01
• Last updated: 2025-10-01

Locations

17 sites across 1 country: China