Status:
NOT_YET_RECRUITING
Anti-IL-5 Therapy With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery for CRSwNP
Lead Sponsor:
Eye & ENT Hospital of Fudan University
Conditions:
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 g...
Eligibility Criteria
Inclusion
- Endoscopy shows bilateral nasal polyps, with bilateral NPS ≥4 (≥2 per side)
- Nasal obstruction symptoms \>3 months, nasal obstruction score ≥2 (total 3 points) and/or hyposmia ≥2 (maximum 3 points)
- 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
- 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
- Cystic fibrosis, Young's syndrome, Kartagener syndrome, antrochoanal polyp, or rhinitis medicamentosa
- Acute upper respiratory infection within 2 weeks
- Asthma exacerbation within 1 month
- HIV infection
- Parasitic infection within 6 months
- History of hypersensitivity to investigational drugs (except aspirin intolerance)
- Hypersensitivity to monoclonal antibodies or anti-IL-5 agents
- Oral steroid therapy within 1 month
- Pregnancy planning, current pregnancy, or lactation
- Uncontrolled systemic diseases
- Have a history of previous sinus surgery for CRSwNP
- Significant septal deviation affecting unilateral ventilation (mild deviation allowed)
- Investigator judgment of unsuitability for cohort study
Key Trial Info
Start Date :
October 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2031
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT07200336
Start Date
October 8 2025
End Date
October 10 2031
Last Update
October 1 2025
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
2
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
3
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
4
Longgang District Central Hospital of Shenzhen
Shenzhen, Guangdong, China, 518000