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临床试验/NCT01376830
NCT01376830已完成不适用

Biomarkers and Clinical Characteristics That Identify the Risk of an Exacerbation Following Viral Upper Respiratory Tract Infections in COPD Patients

Imperial College London1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2011年6月最近更新:
适应症

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.

  1. 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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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