ACTRN12623001271695尚未招募Unknown
An Australian Mepolizumab Registry-based research program with a series of embedded cross-sectional cohort studies to investigate the clinical, immunological, economic and health literacy characteristics of long-term remission of severe asthma treated with mepolizumab
niversity of Newcastle0 个研究点目标入组 80 人开始时间: 2023年12月6日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
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
- •Primary outcome: Participants enrolled in Australian Mepolizumab Registry (ACTRN12618001497291) who have completed 2 years of treatment.
- •Cross-sectional biospecimen and qualitative studies:
- •1. Group a: participants meeting Australian PBS criteria for commencement of mepolizumab therapy for severe eosinophilic asthma.
- •2. Group b: participants with severe asthma who have received mepolizumab treatment for 2 years who meet remission criteria.
- •3. Group c: participants with severe asthma who have received mepolizumab treatment for 2 years who do not meet remission criteria.
- •4. Group d: participants without current diagnosis of lung disease.
排除标准
- •Group a: Participant must not have received another PBS-subsidised biological medicine prescribed for severe asthma in the prior 3 months.
- •All groups: No respiratory infection in prior 4 weeks to visit, and for participants with asthma (groups a-c) no exacerbation of asthma in prior 4 weeks to visit.
研究者
相似试验
尚未招募
Unknown
Australian Mepolizumab Registry for Chronic Rhinosinusitis with Nasal Polyps (AMR-CRSwNP)ACTRN12623000692639The University of Newcastle140
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