2023-505426-34-01招募中4 期
Mepolizumab and in-office nasal polypectomy in patients with chronic rhinosinusitis (CRS). A three arm study.
Instituto De Investigacion Marques De Valdecilla11 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年10月20日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 11
- 主要终点
- SINO-NASAL OUTCOME TEST (SNOT-22)
研究概览
简要总结
Primary endpoint is the improvement in quality of life, determined by sinonasal outcome test (SNOT-22) result
研究设计
- 分配方式
- Randomized
- 主要目的
- Mepolizumab and in-office nasal polypectomy in patients with chronic rhinosinusitis (CRS).
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant 18 years of age or older
- •Patients with a diagnosis of CRS with polyposis according to the criteria of the EPOS2020 guideline: Chronic rhinosinusitis with nasal polyps in adults is defined as presence of two or more symptoms, one of which should be either nasal blockage / obstruction / congestion or nasal discharge (anterior / posterior nasal drip); ± facial pain/pressure; ± reduction or loss of smell; for ≥12 weeks; and either endoscopic signs of nasal polyps, and/or CT changes: mucosal changes within the ostiomeatal complex and/or sinuses.
- •Patients with indication for biologic treatment according to the criteria of the EPOS2020 guideline.
- •Presence of bilateral polyps in a patient who had ESS (except in cases where the patient is not fit for surgery, see bellow) and three of the following criteria are required: 3.
- •Evidence of type 2 inflammation (tissue eos> 10/hpf* or blood eos>250, OR total IgE> 100). * Whenever possible histology from previous surgery should be reviewed to confirm if eosinophilic pathology. If the previous surgery was performed more than 2 years earlier, a blood eosinophil count is essential, as the previous biopsy data may not be relevant. 3.
- •Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (>3 months) 3.
- •Significantly impaired quality of life (SNOT ≥ 40) 3.
- •Significant loss of smell (≥7 VAS) 3.
- •Diagnosis of comorbid asthma
- •Basal eosinophil count (BEC) ≥300 cells/µL for surgical naïve patients- only those not fit for surgery (major criteria) or for those who have had surgery and have recurrence (minor criteria).
- •Patients have been informed and signed consent to participate in the study.
- •For those patients not suitable for surgery, the criteria of the EUFOREA guidelines for indication of biological treatment will be used (4 criteria, one of them being ≥300 cells/µL BEC).
排除标准
- •Any serious or uncontrolled systemic or psychiatric illness that prevents a correct cognitive or endoscopic assessment or does not advise participation in the study.
- •Unilateral localized secondary CRS (odontogenic, fungal ball, tumor)
- •Bilateral diffuse secondary CRS (cystic fibrosis; eosinophilic granulomatosis with polyangiitis-S. de Churg-Strauss-; granulomatosis with polyangiitis-S de Wegener-; primary ciliary dyskinesia; selective immunodeficiencies.
- •Pregnancy/ breast feeding.
- •Hypersensitivity to mepolizumab or it’s excipients.
- •Patients unable to complete the questionnaire or follow prescribed treatment.
- •Patients who are participating in another clinical trial related to polyposis or asthma.
- •Previously documented failure with IL-5/IL-5 receptor biologics
结局指标
主要结局
SINO-NASAL OUTCOME TEST (SNOT-22)
SINO-NASAL OUTCOME TEST (SNOT-22)
次要结局
- Need of rescue therapy with systemic corticosteroids: dose, route of administration, length of treatment, number of treatments.
- Need of rescue surgery (either in-office polypectomy or full endoscopic sinus surgery)
- The resected polyp in the polypectomy groups will be sent for histology to confirm that it is eosinophilic and to obtain evidence of type 2 inflammation (tissue eos> 10/hpf)
- The safety of the treatment will be assessed by collecting Adverse Events at each of the study visits.
- VAS score for nasal symptoms
- The following measurement will be assessed using a nasopharyngoscope: 1. CRSwNP: Lund-Kennedy scale 2. CRSwNP: Meltzer scale
研究者
galo peralta
Scientific
Instituto De Investigacion Marques De Valdecilla
研究点 (11)
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