Not Yet RecruitingPhase 4

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

China360 participantsStarted 2025-10-08

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

The Change in SNOT-22 Score

Timeframe: Baseline,Month12

Change in Nasal Congestion Score

Timeframe: Baseline, Month 12

Trial details

NCT IDNCT07200336

SponsorEye & ENT Hospital of Fudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-10-10

Contact for this trial

Huabin Li, PhD

86-18816993402 allergyli@163.com

View on ClinicalTrials.gov More Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) trials