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

Eye & ENT Hospital of Fudan University

Status and phase: Not yet enrolling; Phase 4

Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Treatments: Drug: Mepolizumab; Procedure: Simple Polypectomy; Procedure: Extended Endoscopic Sinus Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07200336

NPESS-2025

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

Anti-IL-5 Monotherapy

Experimental group

Description:

Mepolizumab 100mg subcutaneously every 4 weeks for 24 weeks

Treatment:

Drug: Mepolizumab

Anti-IL-5 + Simple Polypectomy

Experimental group

Description:

Combined therapy: A 100 mg dose of mepolizumab is initiated subcutaneously 2 weeks after simple polypectomy. Mepolizumab will be administered subcutaneously every 4 weeks for 24 weeks.

Treatment:

Procedure: Simple Polypectomy

Drug: Mepolizumab

Anti-IL-5 + Extended Endoscopic Sinus Surgery

Experimental group

Description:

Combined therapy: A 100 mg dose of mepolizumab is initiated subcutaneously 2 weeks after Extended Endoscopic Sinus Surgery. Mepolizumab will be administered subcutaneously every 4 weeks for 24 weeks.

Treatment:

Procedure: Extended Endoscopic Sinus Surgery

Drug: Mepolizumab