Efficacy of Anti-IL-5 Therapy Combined With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery in Patients With CRSwNP: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 17
- 主要终点
- The Change in SNOT-22 Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Anti-IL-5 Monotherapy
Mepolizumab 100mg subcutaneously every 4 weeks for 24 weeks
干预措施: Mepolizumab (Drug)
Anti-IL-5 + 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.
干预措施: Mepolizumab (Drug)
Anti-IL-5 + 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.
干预措施: Simple Polypectomy (Procedure)
Anti-IL-5 + 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.
干预措施: Mepolizumab (Drug)
Anti-IL-5 + 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.
干预措施: Extended Endoscopic Sinus Surgery (Procedure)
结局指标
主要结局
The Change in SNOT-22 Score
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
研究者
Huabin Li
Professor and Director of the Department of Allergy Center
Eye & ENT Hospital of Fudan University