NCT05002621已完成不适用
Exploratory Investigation of Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma
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
Thanai Pongdee
Principal Investigator
Mayo Clinic
研究点 (1)
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