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临床试验/NCT05002621
NCT05002621已完成不适用

Exploratory Investigation of Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年2月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
20
试验地点
1
主要终点
Differentially Expressed Genes

研究概览

简要总结

The purpose of this study is to identify differentially expressed gene transcripts after initiation of mepolizumab in individuals with severe eosinophilic asthma (SEA).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • •Age ≥ 18 years old.
  • •Diagnosis of SEA by a health care provider
  • •History of an absolute eosinophil count ≥ 300/mm^3
  • •Prescription for mepolizumab provided during course of routine clinical care but mepolizumab not yet started

排除标准

  • •Age < 18 years old.
  • •Pregnancy.
  • •Currently using or have used within 3 months of the initial baseline visit any biologic or immunomodulatory therapy with the exception of #
  • •Currently using or any prior use of rituximab.
  • •History of upper/lower respiratory tract infection or asthma exacerbation within the previous four weeks of the first baseline visit.
  • •Any prior history of malignancy, autoimmune disease, or immune deficiency.
  • •Any other significant medical issue as determined by the principal investigator.

研究组 & 干预措施

severe eosinophilic asthma (SEA)

Twenty consecutive patients who were diagnosed with SEA by a health care provider were prospectively enrolled

干预措施: Observational (Other)

结局指标

主要结局

Differentially Expressed Genes

时间窗: 12 weeks post initiation of mepolizumab

Peripheral blood mononuclear cells (PBMCs) were isolated from blood samples for bulk RNA sequencing. Paired differential expression (DE) gene analysis was performed comparing baseline gene expression versus 12 weeks post initiation of mepolizumab.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thanai Pongdee

Principal Investigator

Mayo Clinic

研究点 (1)

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