Effectiveness of Mepolizumab in the Treatment of Patients With Severe Uncontrolled CRSwNP: a Multicentric Real Life Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 199
- 试验地点
- 27
- 主要终点
- Nasal Polyp Score
研究概览
简要总结
Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a complex chronic inflammatory disease of the nasosinusal mucosa that has a significant negative impact on patients' quality of life.
In CRSwNP, chronic inflammation is primarily driven by type 2 pro-inflammatory interleukins (ILs )such as IL-5, IL-4, and IL-13 along- side high levels of eosinophils in the surrounding tissue. Mepolizumab is a targeted, humanized anti-IL-5 antibody that prevents IL-5 from binding to its receptor on eosinophils and selectively inhibits eosinophilic inflammation.
So far, randomized clinical trials have assessed efficacy and safety of Mepolizumab in a large number of patients, whereas evidences in real life clinical practice are limited to few monocentric series.
Herewith, we present a multicenter, observational, prospective/retrospective nationwide real-life study with the aim to confirm the effectiveness and the safety of Mepolizumab over the first year of treatment in a real life setting.
The primary objective of this study is to evaluate the reduction of dimension of nasal polyps and the improvement of quality of life in the patient measured through symptomatologic questionnaires.
The secondary objective is to evaluate improvements in terms of smell dysfunction, comorbidities, biomarkers (nasal cytology and blood eosinophilia), need of surgery or systemic steroids.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age who can sign a written informed consent Confirmed clinical / radiological diagnosis of chronic rhinosinusitis with diffuse naso-sinusal polyposis by nasal endoscopy and/or massive facial CT scan without contrast medium carried out within 6 months prior to the start of therapy;
- •Blood eosinophils >150
- •Severe disease stage, defined by Nasal Polyp Score (NPS) ≥ 5 or nasal obstruction symptom visual analogue scale (VAS) score of >5 and/or Sinonasal outcome tests-22 (SNOT-22) ≥ 50);
- •Inadequate symptom control with intranasal local corticosteroid therapy;
- •Failure of previous medical treatments (at least 2 cycles in the last year of systemic corticosteroid) and failure of previous surgical treatment through nasal endoscopic surgery (FESS), with no clinical benefit or postoperative complications.
排除标准
- •Age <18 years;
- •Patients undergoing immunosuppressive therapies;
- •Patients undergoing radio/chemotherapy treatments for cancer in the 12 months before the start of therapy;
- •Patients on concomitant long-term corticosteroid therapy for chronic autoimmune disorders.
研究组 & 干预措施
Severe, uncontrolled CRSwNP patients in therapy with Mepolizumab
干预措施: Mepolizumab Auto-Injector (Drug)
结局指标
主要结局
Nasal Polyp Score
时间窗: 24 months
Evaluation of polyps volume from 0 (minimum) to 4 (maximum) points for each nasal cavity. Reduced score indicates improvement
Sinonasal Outcome Test - 22
时间窗: 24 months
Questionnaire measuring health-related quality of life. The score is from 0 (minimum) to 110 (maximum). Reduced score indicates improvement
次要结局
- Visual Analogue Scale for nasal obstruction(24 moths)
- Nasal Congestion Score (NCS); score (range 0-3);(24 months)
- Visual Analogue Scale for smell(24 months)
- Sniffing sticks identification test(24 months)
- Change in blood eosinophil count(24 months)
- Adherence to drug therapy with Mepolizumab(24 months)
- Need for rescue oral corticosteroids(24 months)
- Need for surgery(24 months)
研究者
DE CORSO EUGENIO
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS