ACTRN12623000692639尚未招募Unknown
Australian Mepolizumab Registry for Chronic Rhinosinusitis with Nasal Polyps
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participants will have a confirmed diagnosis of severe CRSwNP with eosinophilic inflammation. They will be eligible for assessment for commencement of Pharmaceutical Benefits Scheme (PBS)-subsidised mepolizumab per below criteria #3-7 (OR eligible to commence mepolizumab for CRSwNP outside of the PBS restrictions)
- •1.Able to provide informed consent
- •2.Age greater than or equal to 18 years
- •3.Diagnosis of CRSwNP confirmed by direct nasal examination (OR diagnosis from at least 2 physicians/ENTs experienced in management of CRSwNP)
- •4.Peripheral blood eosinophil (PBE) count of greater than or equal to 300 cells/µL
- •5.Adherence to intranasal corticosteroid therapy for at least 2 months (unless contraindicated or not tolerated)
- •6.Previous nasal polyps surgery; OR details of surgical exception
- •7.At least 2 of the following:
- •-Baseline bilateral nasal polyp (NP) score of greater than or equal to 5 (out of maximum score of 8, with minimum score of 2 in each nasal cavity)
- •-Baseline nasal obstruction visual analogue score (VAS) of > 5 (out of 10)
- •-Baseline overall symptom visual analogue score (VAS) of > 7 (out of 10)
- •8.Able to access a telephone and/or computer with internet
排除标准
- •1.People highly dependent on medical care
- •2.Cognitive impairment preventing data collection
研究者
相似试验
尚未招募
Unknown
Further Understanding asThma REmission: the FUTURE research programSevere AsthmaRespiratory - AsthmaACTRN12623001271695niversity of Newcastle80
暂停
不适用
Australian Mepolizumab Registry (AMR) for Severe AsthmaACTRN12618001497291Hunter New England Local Health District400
进行中（未招募）
1 期
Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome)MedDRA version: 20.0Level: LLTClassification code 10018701Term: Granulomatous diseaseSystem Organ Class: 100000004867MedDRA version: 20.0Level: LLTClassification code 10014956Term: Eosinophilic granulomaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10072580Term: Granulomatous polyangiitisSystem Organ Class: 100000004866MedDRA version: 20.1Level: LLTClassification code 10014957Term: Eosinophilic granulomatous vasculitisSystem Organ Class: 100000004870MedDRA version: 20.0Level: LLTClassification code 10056218Term: Necrotising granulomatous vasculitisSystem Organ Class: 100000004866MedDRA version: 20.0Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 100000004855MedDRA version: 20.0Level: LLTClassification code 10036023Term: PolyangiitisSystem Organ Class: 100000004866EUCTR2014-003162-25-BEGlaxoSmithKline Research Ltd115
进行中（未招募）
1 期
Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome)MedDRA version: 20.0Level: LLTClassification code 10018701Term: Granulomatous diseaseSystem Organ Class: 100000004867MedDRA version: 21.1Level: LLTClassification code 10072580Term: Granulomatous polyangiitisSystem Organ Class: 100000004866MedDRA version: 21.0Level: LLTClassification code 10014956Term: Eosinophilic granulomaSystem Organ Class: 100000004864MedDRA version: 20.1Level: LLTClassification code 10014957Term: Eosinophilic granulomatous vasculitisSystem Organ Class: 100000004870MedDRA version: 21.1Level: LLTClassification code 10056218Term: Necrotising granulomatous vasculitisSystem Organ Class: 100000004866MedDRA version: 21.1Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 100000004855MedDRA version: 21.1Level: LLTClassification code 10036023Term: PolyangiitisSystem Organ Class: 100000004866EUCTR2014-003162-25-DEGlaxoSmithKline Research Ltd115
进行中（未招募）
1 期
Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921EUCTR2014-003162-25-GBGlaxoSmithKline Research Ltd42