Effectiveness on Sino-Nasal Symptoms Of Mepolizumab 300 In Patients Affected by Egpa and Concomitant Severe and Uncontrolled CRSwNP: Italian Multicentric "Real-Life" Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
研究概览
简要总结
OBJECTIVES The primary objective of this study is evaluating the reduction of dimension of nasal polyps measured with Nasal Polyp Endoscopic Score (NPS) The secondary objective is to evaluate the improvement in nasal symptoms and quality of life in the patient measured through symptom questionnaires, the improvements in terms of smell dysfunction and symptomatology related to eosinophilic otitis media;evaluate the need of surgery or systemic corticosteroids.
ENDPOINTS Primary endpoint The primary endpoints will be the Improvement of NPS score (indicative of polyps score reduction) at 12 months after start of therapy.
Secondary endpoints
- Improvement of SNOT-22 score (indicative of an improvement in quality of life)
- Improvement of VAS score for nasal obstruction
- Improvement of Nasal Congestion Score (NCS)
- Improvement of VAS score for smell;
- Improvement of sniffin' sticks score;
- Evaluate adherence to drug therapy with Mepolizumab 300, any suspension of the same and reasons for discontinuing treatment (lack of efficacy, complications reported, safety profile);
- Assess how many patients require FESS surgery and/or systemic steroids for sino-nasal symptoms during treatment;
- Evaluate the improvement of symptoms of any associated comorbidities and in particular chronic eosinophilic otitis media.
Study design Observational, retrospective/prospective, non-profit and national multicenter real-life study.
详细描述
Population. patients affected by EGPA and concomitant severe chronic rhinosinusitis with nasal polyps (CRSwNP) not controlled by local and systemic corticosteroids and/or surgery, who have received indication, during normal clinical practice, to therapy with Mepolizumab 300mg every 4 weeks (self-administered at home with subcutaneous autoinjector), in addition to topical nasal corticosteroids.
Duration of the study The foreseen study duration is of 18 months since the approval of the present protocol by the Local Ethics Committee.
Inclusion criteria
Eligible patients will be:
- Patients over 18 years of age who can sign a written informed consent;
- Confirmed diagnosis of EGPA by rheumatologist and in treatment with Mepolizumab 300 mg every 4 weeks, according to clinical pratice;
- 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;
- Severe disease stage, defined by Nasal Polyp Score (NPS) ≥ 5 or nasal obstruction symptom visual analogue scale (VAS) score of >5 and/or 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) or failure of previous surgical treatment through nasal endoscopic surgery (FESS), with no clinical benefit or postoperative complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Eligible patients will be:
- •Patients over 18 years of age who can sign a written informed consent;
- •Confirmed diagnosis of EGPA by rheumatologist and in treatment with Mepolizumab 300 mg every 4 weeks, according to clinical pratice;
- •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;
- •Severe disease stage, defined by Nasal Polyp Score (NPS) ≥ 5 or nasal obstruction symptom visual analogue scale (VAS) score of >5 and/or 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) or 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 with EGPA with organ impairment or at risk of death;
- •Patients undergoing radio/chemotherapy treatments for cancer in the 12 months before the start of therapy.
研究者
De Corso Eugenio
Doctor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS