COPD Clinical Research Network

描述（由申请人提供）： 在美国，慢性阻塞性肺疾病是导致死亡和残疾的主要原因。影响对COPD进行有效研究的因素包括：对该疾病不可逆和不可治疗的误解，以及对评估该患者人群的最佳功能结局指标缺乏共识。COPD临床研究网络（CRN）代表了NIH的一项重要承诺，即解决这些阻碍COPD有效研究的障碍。因此，我们本提案的主要目的是：通过满足必要的亚临床招募目标，提供多中心试验的专家执行，并提供亚临床表征和结局创新技术方面的专业知识，为COPD临床研究网络做出富有成效的贡献。 我们的中心带来了在多中心临床试验中获得的丰富经验，包括NIH赞助的NETT，FORTE和肺部健康研究。这一经验与我们接触到大量研究感兴趣的主题相结合，证实了我们将成为COPD-CRN的强大贡献者。我们招募的范围包括IRB批准的肺气肿登记;最近完成肺部健康研究的受试者;我们参与匹兹堡SPORE（高风险吸烟者筛查项目）;以及扩展的三级护理医院网络。我们还带来了在使用运动，肺力学和定量计算机断层扫描在COPD的结果评估的科学研究的强有力的记录。这些技能与我们在不列颠哥伦比亚省大学和我们自己的临床药理学部门的强大的基础科学合作者协同作用。最近的一篇期刊社论指出：“匹兹堡的患者人群与温哥华的病理学专业知识相结合，证明了地理上分离的中心之间合作的力量。" 我们提出的项目代表了针对COPD不同类别结局的临床试验，这些临床试验具有完整性，独立于特定干预措施。项目1研究抗炎药（氟替卡松）对COPD急性加重严重程度的影响。我们将考虑将此设计作为测试其他不断发展的抗炎药物类别的基础。项目2讨论了对吸入性支气管扩张剂反应的个体差异，并试图根据肺功能、功能表现和症状的创新指标来区分最有可能获益的受试者。这种方法可以应用于其他干预措施假设，以提高功能能力。我们相信，我们强大的临床试验经验，对研究感兴趣的主题的非凡访问以及基础和临床科学记录将使我们成为COPD-CRN的强有力参与者。

DESCRIPTION (provided by applicant): Chronic obstructive pulmonary disease is a leading cause of death and disability in the U.S. Factors, which have impaired effective research in COPD, include misconceptions that the disease is irreversible and untreatable and a lack of consensus on optimal functional outcome measures available to assess this patient population. The COPD clinical research network (CRN) represents an important commitment by the NIH to address these impediments to effective research in COPD. Thus our primary aim of this proposal will be to: CONTRIBUTE PRODUCTIVELY TO THE COPD CLINICAL RESEARCH NETWORK BY MEETING NECESSARY SUBJECT RECRUITMENT GOALS, PROVIDING EXPERT LOCAL EXECUTION OFA MULTI-CENTER TRIAL AND OFFER EXPERTISE IN INNOVATIVE TECHNIQUES IN SUBJECT CHARACTERIZATION AND OUTCOMES. Our center brings extensive experience gained in multicenter clinical trials including the NIH sponsored NETT, FORTE and Lung Health Studies. This experience combined with our access to large numbers of research-interested subjects confirms that we would be a strong contributor to the COPD-CRN. The breadth of our recruitment extends from our IRB approved emphysema registry; subjects recently completing the Lung Health study; our participation with the Pittsburgh SPORE (high risk smoker screening project); and an extended tertiary care hospital network. We also bring a strong record of scientific investigation in the use of exercise, pulmonary mechanics and quantitative computed tomography in the assessment of outcome in COPD. These skills synergize with those of our strong basic science collaborators at the University of British Columbia and in our own Division of Clinical Pharmacology. A recent journal editorial noted: "the combination of a well characterized patient population in Pittsburgh with the pathology expertise in Vancouver, demonstrates the power of collaboration between centers geographically separated." Our proposed projects represent clinical trials targeting different categories of outcome in COPD that have integrity, independent of the specific intervention. Project 1 addresses the impact of an anti-inflammatory agent (fluticasone) on the severity of COPD exacerbation. We would consider this design as a basis for testing other evolving classes of anti-inflammatory pharmaceutical agents. Project 2 addresses the individual variation in response to inhaled bronchodilators and attempts to discriminate subjects, which are most likely to benefit, based upon innovative measures of lung function, functional performance and symptoms. Such an approach can be applied to other interventions hypothesized to improve functional capacity. We believe that our strong clinical trials experience, extraordinary access to research interested subjects and basic and clinical science record would make us strong participants in the COPD-CRN.