Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07200336
PHASE4

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

Sponsor: Eye & ENT Hospital of Fudan University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2025-10-08

Completion Date

2031-10-10

Last Updated

2025-10-01

Healthy Volunteers

No

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.

Locations (17)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Longgang District Central Hospital of Shenzhen

Shenzhen, Guangdong, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The Second Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Renmin hospital of Wuhan University

Wuhan, Hubei, China

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, Shanghai Municipality, China

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

Shanghai, Shanghai Municipality, China

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

The Affiliated Hospital of Yunnan University

Kunming, Yunnan, China

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

Hangzhou, Zhejiang, China