CTIS2023-505426-34-01进行中（未招募）1 期
Mepolizumab and in-office nasal polypectomy in patients with chronic rhinosinusitis (CRS). A three arm study. - MELYSA
Instituto De Investigacion Marques De Valdecilla0 个研究点目标入组 75 人开始时间: 2023年7月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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. 3. 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: 3.1. 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. 3.2. Need for systemic corticosteroids or contraindication to systemic steroids (= 2 courses per yr, OR long term (>3 months) 3.3. Significantly impaired quality of life (SNOT = 40) 3.4. Significant loss of smell (=7 VAS) 3.5. 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
研究者
相似试验
已完成
2 期
Effect of mepolizumab in eosinophilic chronic rhinosinusitisChronic rhinosinusitisACTRN12618000113257Richard Harvey20
尚未招募
4 期
Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.Rhinosinusitis ChronicPolyp, NasalNCT05923047Instituto de Investigación Marqués de Valdecilla75
尚未招募
不适用
Mepolizumab in the Treatment of Patients With Severe Uncontrolled CRSwNP: a Multicentric Real Life Observational StudyChronic Rhinosinusitis With Nasal PolypsNCT06258772Fondazione Policlinico Universitario Agostino Gemelli IRCCS199
Unknown
4 期
Omalizumab Efficacy in Patients With Refractory Nasal PolypsNasal PolypsNCT05405478Shiraz University of Medical Sciences2
招募中
不适用
eGPA and Local Inflammation Within the Ear, Nose and Throat AreaEGPA - Eosinophilic Granulomatosis With PolyangiitisNCT06298448University Medical Center Groningen150