Evaluation of Biomarkers of COPD Exacerbation
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- SAA/lipoxin A4 ratio
研究概览
简要总结
Serum amlyoid A (SAA) was shown to act as biomarker for exacerbation of chronic obstructive pulmonary disease (AE-COPD). It seems that SAA triggers chronic inflammation by binding to ALX/PFR2 receptor. In contrast, lipoxin A4 seems to inhibit the inflammatory processes by binding to ALX/PFR2 receptor. A small trial has already demonstrated an imbalance between SAA and lipoxin A4 during AE-COPD. This study evaluates SAA level and SAA/lipoxin A4 ratio in patients with stable COPD and AE-COPD.
详细描述
Patient enrolment and data aquisition is to be carried out on a prospective basis. It is planned to enrol 40 patients with stable COPD and 40 patients with AE-COPD. All patients will undergo blood sampling inlcuding SAA and Lipoxin A4.
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
- •Patients with COPD GOLD 3-4 confirmed by anamnesis and pulmonary function test
- •Patient has provided written informed consent
排除标准
- •other reasons for worsening of symptoms (cough, dyspnea): e.g. pneumothorax, pneumonia, pulmonary embolism, myocardial infarction.
- •malignant disease
结局指标
主要结局
SAA/lipoxin A4 ratio
时间窗: time of exacerbation/hospitalisation, an average of 3 days
SAA/lipoxin A4 ratio in stable COPD and COPD exacerbation
SAA
时间窗: time of exacerbation/hospitalisation, an average of 3 days
SAA level in stable COPD and COPD exacerbation
次要结局
未报告次要终点
研究者
Daniela Gompelmann
PD Dr. med. Daniela Gompelmann
Heidelberg University