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临床试验/NCT01620645
NCT01620645Unknown不适用

The Mechanisms of Inflammation and Immunity in COPD and Their Relationship to Exacerbations and Disease Progression.

University College, London1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1

研究概览

简要总结

The UK Medical Research Council (MRC) together with the Association of British Pharmaceutical Industries (ABPI) have recently funded a program designed to foster collaboration between academic COPD researchers and the pharmaceutical industry in the UK, with the aim of developing and furthering our research capacity and expertise for the benefit of patients living with this prevalent and disabling condition. This builds on the strong international track record of COPD research in the UK. The program is divided into four work packages (WP1-4), each with specific aims. WP1 will collate and establish data from patient cohorts and share this information through the development of knowledge management platforms. WP2 will specifically assess how airway micro-organisms impact on COPD and how the effects of bacteria and viruses may be modified. WP3 is concerned with tissue injury and repair which are fundamental processes in the development of COPD. WP4 will examine in detail the potential for improving patient outcomes by targeting the skeletal muscle dysfunction that can profoundly affect exercise capacity.

详细描述

This study is a multi-centre UK based observational study of a cohort of patients with chronic obstructive pulmonary disease (COPD) funded by the MRC, as part of the MRC/ABPI Inflammation and Immunology Initiative in COPD. This consortium brings together key researchers in the COPD research community with long-standing expertise in understanding bacterial infection, inflammation and immunity.

Understanding the role of bacterial and viral infections, which are often the trigger for exacerbations, and the mechanism of tissue re-modelling and repair following exacerbations is extremely important. Exacerbations and the progression of the disease impose a considerable disability on patients and a financial burden on the health service. In additional, pulmonary inflammation in COPD may result in systemic inflammation. This is associated skeletal muscle dysfunction, as well as worsening other common diseases, such as cardiovascular disease.

We now have a much better understanding of the cellular and molecular mechanisms that underlie COPD and cause the chronic inflammatory process, both locally within the lung and systemically. However, current therapy for COPD is inadequate and relies on long-acting bronchodilators, which do not ameliorate the underlying chronic inflammatory process. Currently available anti-inflammatory therapies are incompletely effective. An improved understanding of the complex mechanisms in COPD is required in order to develop future effective treatments, for which there is a pressing need.

Patients will be recruited from existing cohorts of COPD patients, and indirectly through their general practitioner and outpatient clinics. Patients must have COPD, and all patients will be assessed to ensure the correct diagnosis.

Study patients will be phenotyped by lung morphology and function, biomarkers in blood, sputum and urine, bacterial and viral load in sputum, cardiovascular behaviour, co-morbidities and skeletal muscle function. The patients will be followed up over initially 18 months, with a planned extension to 5 years, to accurately determine the relationship between bacterial and viral infections, tissue re-modelling and skeletal muscle dysfunction with exacerbation frequency and disease progression.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed spirometric evidence of moderate to very severe COPD (stage II to IV) according to the WHO GOLD criteria:
  • All patients FEV1/FVC <70%
  • Stage II FEV1 50-80% predicted
  • Stage III FEV1 30-50% predicted
  • Stage IV FEV1 <30% predicetd or <50% predicted and chronic respiratory symptoms
  • Past or present smokers
  • Gender: male or female
  • Age >40 years at recruitment
  • Reasonable command of English to complete daily diary cards

排除标准

  • History of asthma
  • History of neoplasia
  • History of other significant respiratory disease
  • Pregnancy

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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