Relationship Between Patient Phenotypes and Exacerbations in Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Annual exacerbation rate (number of exacerbations over a 12 month period)
研究概览
简要总结
The London COPD exacerbation (EXCEL) cohort builds on an established cohort started in 1995 and designed to study COPD exacerbations and their impact on health-status and disease progression.
详细描述
Our intentions are to phenotype Chronic Obstructive Pulmonary Disease (COPD) patients on the basis of factors that a related to (a) exacerbation frequency which will include (b) lung function to assess disease severity, (c) baseline therapy, (d) airway and systemic inflammatory markers, (e) health status, (f) gene expression, (g) airway bacterial and viral load and (h) co-morbidity including cardiovascular disease, diabetes and psychological disease, (i) psychological factors,(j) mortality, (k) nasal susceptibility to rhinovirus infection, (l) heart rate variability (m) exhaled hydrogen sulphide.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Forced Expiratory Volume in 1 sec (FEV1)/Forced Vital Capacity (FVC) ratio of <0.70
- •Able and willing to give informed and written consent
排除标准
- •Patients with a history of asthma, bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease were excluded.
- •Patients on Immunosuppressive medications or with active cancer
- •Long term steroid therapy
- •Age <40 years at recruitment
结局指标
主要结局
Annual exacerbation rate (number of exacerbations over a 12 month period)
时间窗: 12 months
Definition of an exacerbation * The presence of 2 new symptoms (one of which must be major) for 2 consecutive days * Major symptoms: increased breathlessness (A), increased sputum colour (B1) or increased sputum amount (B2) * Minor symptoms: a cold (C), increased wheeze or chest tightness (D), Sore throat (E1), Increased cough (E2), Fever (F)
次要结局
未报告次要终点