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

Not Applicable

Not yet recruiting

• Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
• Interventions: Drug: Mepolizumab; Procedure: Simple Polypectomy; Procedure: Extended Endoscopic Sinus Surgery

• Registration Number: NCT07200336
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-13
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Study Start: 2025-10-08
• Primary Completion: 2029-10-10
• Study Completion: 2031-10-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti-IL-5 Monotherapy	Mepolizumab	Mepolizumab 100mg subcutaneously every 4 weeks for 24 weeks
Anti-IL-5 + Simple Polypectomy	Mepolizumab	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.
Anti-IL-5 + Simple Polypectomy	Simple Polypectomy	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.
Anti-IL-5 + Extended Endoscopic Sinus Surgery	Mepolizumab	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.
Anti-IL-5 + Extended Endoscopic Sinus Surgery	Extended Endoscopic Sinus Surgery	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.

Primary Outcome Measures

Name	Time	Method
The Change in SNOT-22 Score	Baseline,Month12	The 22-item Sinonasal Outcome Test (SNOT-22) is a questionnaire comprising 22 questions on health-related quality of life in rhinosinusitis. For each item, patients provide a subjective rating on a scale from 0 to 5, where 0 represents "No problem" and 5 represents "Problem as bad as it can be." The total score is the sum of all items and ranges from a minimum of 0 to a maximum of 110. A higher total score indicates a worse outcome, reflecting a poorer quality of life due to rhinosinusitis.
Change in Nasal Congestion Score	Baseline, Month 12	The Nasal Congestion Score (NCS) is a patient-reported outcome measure that assesses the subjective severity of nasal congestion. The score ranges from a minimum of 0 to a maximum of 3, where 0 represents "No nasal congestion" and 3 represents "The most severe nasal congestion." A higher score indicates a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Change in SNOT-22 Score	Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,24,36 month after biological treatment initiation	The 22-item Sinonasal Outcome Test (SNOT-22) is a questionnaire comprising 22 questions on health-related quality of life in rhinosinusitis. For each item, patients provide a subjective rating on a scale from 0 to 5, where 0 represents "No problem" and 5 represents "Problem as bad as it can be." The total score is the sum of all items and ranges from a minimum of 0 to a maximum of 110. A higher total score indicates a worse outcome, reflecting a poorer quality of life due to rhinosinusitis.
Change in Nasal Congestion Score	Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,24,36 month after biological treatment initiation	The Nasal Congestion Score (NCS) is a patient-reported outcome measure that assesses the subjective severity of nasal congestion. The score ranges from a minimum of 0 to a maximum of 3, where 0 represents "No nasal congestion" and 3 represents "The most severe nasal congestion." A higher score indicates a worse outcome.
Change in Nasal Polyp Score (NPS)	Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation	The Nasal Polyp Score (NPS) is an objective assessment tool, evaluated by a clinician, used to grade the size of nasal polyps. Each nasal cavity is scored separately on a scale from 0 to 4. The total score is the sum of the scores from both nostrils and ranges from a minimum of 0 to a maximum of 8. A higher score indicates larger nasal polyps and a worse outcome. The scoring criteria are as follows: 0: No polyps.; 1. Small polyps in the middle meatus.; 2. Polyps in the middle meatus reaching below the inferior border of the middle turbinate.; 3. Large polyps reaching beyond the inferior border of the middle turbinate or with medial extension from the middle turbinate.; 4. Polyps completely obstructing the nasal cavity.
Change in Modified Lund-Kennedy Score	Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation	The modified Lund-Kennedy (MLK) score is an objective endoscopic evaluation performed by a clinician. A higher score indicates a worse outcome. It scores nasal polyps, edema, and discharge (0-2 for each) per nostril. The total score ranges from 0 to 12, with a higher score indicating worse endoscopic status.
Change in Blood Eosinophil percentage	Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation
Change in Lund-Mackay CT Score	Baseline, at 6,12, 24,36 month after biological treatment	The Lund-Mackay CT scoring system is an objective radiological assessment. It evaluates the extent of opacification on sinus computed tomography (CT) scans in six anatomical regions per side: anterior ethmoid sinuses, posterior ethmoid sinuses, maxillary sinuses, sphenoid sinuses, frontal sinuses, and the ostiomeatal complex. Each region is scored from 0 (no abnormality) to 2 (complete opacification). The total score, which is the sum of scores from all regions across both sides, ranges from a minimum of 0 to a maximum of 24. A higher total score indicates greater disease severity.
Change in Olfactory Function	Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation	We will provide patients with an olfactory questionnaire, asking them to respond to the following questions. Each question will have a corresponding score: 0 points for "strongly disagree," 1 point for "partially agree," 2 points for "incompletely agree," and 3 points for "strongly agree."; The questions include: I feel my sense of smell has become much worse than before. Compared to before the onset of olfactory dysfunction, the taste of food has changed.; Sometimes I can smell unpleasant odors that others cannot detect. Some pleasant smells that others enjoy are unpleasant to me. My biggest issue is that, compared to before the onset of olfactory dysfunction, smells are perceived differently.; Due to changes in my sense of smell, I dine out less often than before. I worry that I will not be able to adapt to the changes in my sense of smell in the future.; Due to changes in my sense of smell, I feel more anxious than before. Changes in my sense of smell often make me feel angry.
Change in FeNO and nNO	Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 3,6,12,24,36 month after first biological treatment
Need for Systemic Corticosteroid	2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation
Objective Olfactory function Test	Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 3,6,12,24,36 month after biological treatment initiation	Olfactory function was evaluated by the Sniffin' Sticks test, containing olfactory threshold (T), discrimination (D) and identification (I) tests . Score for the threshold test range between 1 and 16, while the scores of the other two tests range between 0 and 16. The results of the three tests were calculated as a total TDI score (range 1- 48), which was used to define functional anosmia (TDI ≤ 16), hyposmia (16 \< TDI \< 31), or normosmia (TDI ≥ 31). If the patients had only been assessed by the identification test, the I score was used to define functional anosmia (I ≤ 8), hyposmia (8 \< I ≤ 11), or 113 normosmia (I \> 11).

Trial Locations

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

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