Biannual Review of Exhaled Air and Trends in Health Evaluation in COPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate the longitudinal stability of FeNO levels in COPD patients over a 12-month period with biannual measurements.
研究概览
简要总结
This study aims to evaluate how airway inflammation, lung function, and symptoms change over time in people with chronic obstructive pulmonary disease (COPD). Airway inflammation will be assessed using a simple breath test (FeNO) and a small blood sample to measure eosinophils, a type of white blood cell. Participants will be followed for one year, with three study visits (at the start, 6 months, and 12 months). The goal is to understand how these markers evolve and whether they differ between people who experience a worsening of symptoms (called exacerbations) and those who remain stable. All tests except for a small extra blood draw are part of routine COPD care. Participation does not affect standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 40 years
- •Diagnosed with COPD according to GOLD criteria
- •Attending routine follow-up visits every 6 months
- •Ability to provide informed consent
排除标准
- •Recent respiratory tract infection or exacerbation (either moderate or se-vere) (<4 weeks before inclusion)
- •Dominant asthmatic phenotype (ACO with asthma predominance)
- •Severe comorbidities interfering with participation or follow-up
研究组 & 干预措施
Single Arm: Stable COPD Patients with Longitudinal FeNO and Blood Eosinophil Monitoring
干预措施: Blood eosinophil Count (Diagnostic Test)
结局指标
主要结局
To evaluate the longitudinal stability of FeNO levels in COPD patients over a 12-month period with biannual measurements.
时间窗: from enrollment to the end of the study period (1 year)
次要结局
未报告次要终点