COPD Clinical Research Network

描述(由申请人提供)： 在美国，慢性阻塞性肺病是导致死亡和残疾的主要原因。影响COPD有效研究的因素包括错误地认为这种疾病是不可逆转和不可治疗的，以及在评估这一患者群体的最佳功能结果指标方面缺乏共识。COPD临床研究网络(CRN)代表了美国国立卫生研究院为解决COPD有效研究的这些障碍而做出的重要承诺。因此，我们这项建议的主要目标将是：通过满足必要的受试者招募目标，为COPD临床研究网络做出富有成效的贡献，为FA多中心试验提供专家本地执行，并在受试者特征和结果方面提供创新技术方面的专业知识。 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和肺健康研究。这一经验再加上我们接触到大量对研究感兴趣的受试者，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；我们参与匹兹堡孢子(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来评估COPD结果的科学研究方面的强有力的记录。这些技能与我们在不列颠哥伦比亚大学和我们自己的临床药理学部门强大的基础科学合作者的技能相结合。最近的一篇期刊社论指出：“匹兹堡良好的患者群体特征与温哥华的病理专业知识相结合，展示了地理上分散的中心之间合作的力量。” 我们建议的项目代表了针对COPD不同类别结果的临床试验，这些试验具有完整性，独立于特定的干预。项目1涉及抗炎剂(氟替卡松)对COPD恶化程度的影响。我们会考虑将这一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处理吸入支气管扩张剂后的个体差异，并试图根据肺功能、功能表现和症状的创新测量，区分最有可能受益的受试者。这种方法可以应用于其他假想的提高功能能力的干预措施。我们相信，我们丰富的临床试验经验、获得感兴趣的研究对象的非凡机会以及基础和临床科学记录将使我们成为COPD-CRN的强大参与者。

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.