UAB/BVAMC Clinical Center in COPD

描述(由申请人提供)： 慢性阻塞性肺疾病(COPD)是一个严重的公共卫生问题，每年导致美国50多万人住院，10万人死亡，直接医疗费用高达150亿美元。我们建议在阿拉巴马大学伯明翰分校(UAB)和伯明翰退伍军人事务医疗中心(BVAMC)建立一个合作的COPD CRN临床中心。UAB/BVAMC临床中心将由威廉·C·贝利博士和J.艾伦·D·库珀博士领导。拟议的调查人员及其研究人员在临床试验的招聘和保留以及研究设计和实施方面拥有丰富的经验。UAB和BVAMC之间的合作将使我们能够快速有效地招募大量COPD患者进行临床研究。此外，UAB/BVAMC慢性阻塞性肺病临床中心将接触到阿拉巴马大学伯明翰分校的大型专家网络，他们可以帮助设计和实施临床试验。 UAB/BVAMC临床中心提出了两项旨在加强中重度COPD治疗的研究。第一项研究将检查炎症和对支气管扩张剂挑战的反应性，对全身类固醇治疗的反应性，以及对吸入性类固醇治疗的反应性。这项研究可能为确定最有可能对吸入皮质类固醇有反应的COPD患者亚组提供一种新的方法。第二个项目将研究肺炎球菌疫苗反应差的原因，长期目标是利用这一信息减少COPD患者的肺炎球菌感染和相关恶化。 UAB/BVAMC临床中心还提出了临床研究技能培训核心。加州大学伯克利分校肺部和重症护理医学研究员培训主任J.Allen D.Cooper博士将领导这一核心。学员将获得为期两年的资助，并将被要求参加UAB K30临床研究课程开发奖的一个组成部分(临床研究培训计划或临床研究公共卫生理学硕士学位)。受训人员还将获得一个试点项目的资金，该项目将在培训核心调查员的监督下制定和实施。这些研究人员在慢性阻塞性肺疾病、临床研究和研究设计、行为科学、流行病学和统计学方面拥有专业知识。

DESCRIPTION (provided by applicant): Chronic Obstructive Pulmonary Disease (COPD) is a serious public health problem responsible for more than 500, 000 hospitalizations, 100,000 deaths, and $15 billion in direct costs of medical care in the United States each year. We propose to form a collaborative COPD CRN Clinical Center at the University of Alabama at Birmingham (UAB) and the Birmingham Veterans Affairs Medical Center (BVAMC). The UAB/BVAMC Clinical Center will be headed by, Drs. William C. Bailey and J. Allen D. Cooper. The proposed investigators and their research staff have extensive experience in recruitment and retention for clinical trials, as well as study design and implementation. The collaborative effort between UAB and the BVAMC will allow us to quickly and efficiently recruit large numbers of COPD patients for clinical research studies. In addition, the UAB/BVAMC COPD Clinical Center will have access to a large network of experts at the University of Alabama at Birmingham who can assist in the design and implementation of clinical trials. The UAB/BVAMC Clinical Center proposes two studies aimed at enhancing treatment for moderate-to severe COPD. The first study will examine measures of inflammation and responsiveness to bronchodilator challenge, responsiveness to systemic steroid treatment, and responsiveness to inhaled steroid treatment. This study may provide a new method for identifying subgroups of COPD patients who are most likely to respond to inhaled corticosteroids. The second project will examine the causes of poor responsiveness to the pneumococcal vaccine with the long term goal of using this information to reduce pneumococcal infections and related exacerbations in COPD patients. The UAB/BVAMC Clinical Center also proposes a Clinical Research Skills Training Core. Dr. J. Allen D. Cooper, the Director for fellowship training in Pulmonary and Critical Care Medicine at UAB, will head this core. Trainees will be funded for a total of two years and will be required to enroll in one of the UAB K30 Clinical Research Curriculum Development Award components (either the Clinical Research Training Program or the Master's of Science in Public Health in Clinical Research). Trainees will also receive funding for a pilot project, which will be developed and conducted under the supervision of the Training Core Investigators. These Investigators have expertise in COPD, Clinical Research and Study Design, Behavioral Science, Epidemiology, and Statistics.