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临床试验/NCT06096285
NCT06096285招募中不适用

Heterogeneity and Disease Development of Early Chronic Obstructive Pulmonary Disease

China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
84
试验地点
1
主要终点
Number of participants with COPD exacerbation

研究概览

简要总结

This study aims to investigate the clinical characteristics and heterogeneities of early chronic obstructive pulmonary disease (COPD), to determine the disease development of early COPD, and to establish a multidimensional model for predicting the outcomes of early COPD.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The individuals who meet the defining criteria of PRISm, COPD Stage 0, Pre-COPD, Early COPD, Young COPD, and Mild COPD, according to the latest GOLD documents and publications.

排除标准

  • Age < 18 years or > 80 years;
  • Pregnant or maternal women;
  • Having malignant and active tumor(s), and receiving treatment;
  • Undergoing a surgical operation;
  • Having problems with mental awareness;
  • Having difficulties in daily activities;
  • Participating in other interventional clinical trials.

结局指标

主要结局

Number of participants with COPD exacerbation

时间窗: One year

COPD exacerbation refers to acute deterioration of respiratory symptoms (e.g. cough, sputum, wheeze, dyspnea), especially resulting in hospital visit or admission.

次要结局

  • FVC(One year)
  • FEV1(One year)
  • FEV1% predicted value(One year)
  • The COPD Assessment Test scale(One year)
  • FEV1/FVC ratio(One year)
  • FVC% predicted value(One year)
  • The modified Medical Research Council dyspnea scale(One year)

研究者

发起方
China-Japan Friendship Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jieping LEI, Ph.D.

Principal Investigator

China-Japan Friendship Hospital

研究点 (1)

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Heterogeneity and Development of Early COPD | 临床试验