Biomarkers and Clinical Characteristics That Identify the Risk of an Exacerbation Following Viral Upper Respiratory Tract Infections in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Proportion of colds followed by exacerbations in COPD patients
研究概览
简要总结
Respiratory virus infections are a common cause of COPD exacerbations and antiviral therapies have potential as treatments for exacerbations. However it is likely that treating patients when they present with an exacerbation with antiviral drugs will be too late to be effective and earlier treatment at the time of the initial upper respiratory tract infection (URTI) will be required. The incidence of exacerbations following URTIs in COPD patients, and whether there are host factors and biomarkers that can identify the risk of this, is unknown. The aims of this study are to establish the proportion of viral URTIs that progress to an acute exacerbation in COPD patients and identify clinical, viral and biological markers that predict risk of an exacerbation following an URTI. In addition we will determine the frequency of, and risk factors for, bacterial infection following viral URTIs in COPD patients. This data will permit development of a model combining baseline patient characteristics, clinical measurements and biomarkers to predict exacerbation risk following viral URTI in COPD patients. The results will open the way for trials of antiviral therapy in COPD exacerbations and targeting of treatment to high risk patients.
详细描述
Research Protocol
Biomarkers and clinical characteristics that identify the risk of an exacerbation following viral upper respiratory tract infections in COPD patients
Chief Investigator: Dr Patrick Mallia Co-investigators: Professor Sebastian Johnston Dr Sarah Elkin
Study Site The study will take place at St Mary's Hospital, London - part of the Imperial College Healthcare NHS Trust.
- Background COPD exacerbations are a major cause of health care costs, morbidity and mortality. Current therapies are only partially effective and have considerable side effects so new treatments are urgently needed. 40 - 50% of COPD exacerbations are associated with virus infections and the commonest viruses detected are rhinoviruses and influenza1,2. Sensitive and rapid diagnostic techniques for viral infections have recently become available3 and drugs effective against rhinovirus and influenza have been developed4, making antiviral therapy a realistic potential treatment option for COPD exacerbations. However our understanding of the relationship between viral infections and COPD exacerbations remains limited and a more information is required before trials of antiviral therapies are carried out.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-85
排除标准
- •Unable to understand English
- •Expected life expectancy < 2 years
- •Unable to attend hospital
结局指标
主要结局
Proportion of colds followed by exacerbations in COPD patients
时间窗: 2 years
次要结局
- Changes in bacterial flora following colds in COPD patients(2 years)
- Clinical characteristics that identify high risk of exacerbation following a cold in COPD patients(2 years)
- Biomarkers that identify the risk of exacerbation following colds in COPD patients(2 years)
