Correlations Between Airway Inflammation, Symptoms and Lung Functions in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Correlation between changes in airway inflammation and symptom score
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease with high prevalence worldwide and with relevant impact on patient-related quality of life, morbidity and mortality. There is evidence that airway inflammation correlates with the severity of the disease and that airway inflammation is further enhanced during exacerbation. However, it is unknown whether daily fluctuation of symptoms or changes in lung function is paralleled by changes in airway inflammation.
详细描述
Patients will undergo a visit every 7 days during one month (5 visits in total). At each visit airway inflammation (exhaled NO, sputum inflammatory cell count) and lung function will be performed. At home patients will be asked to fill a daily diary for symptom assessment.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-bronchodilator FEV1/FVC ratio < 70%
- •Post-bronchodilator FEV1 < 80%
- •Smokers or ex-smoker with pack/years > 15
排除标准
- •Concomitant lung diseases (e.g. lung cancer)
- •Acute infections of the respiratory tree in the previous 2 months including COPD exacerbation.
结局指标
主要结局
Correlation between changes in airway inflammation and symptom score
时间窗: 1 month,
Correlation between changes in airway inflammation and symptom score will be evaluated
次要结局
- Correlations between airway inflammation and symptom scores(1 month)
- Correlations between airway inflammation and lung function(1 month)
- Correlation between changes in airway inflammation and lung function(1 month)
研究者
Alberto Papi
Professor
Università degli Studi di Ferrara