Asthma Clinical Research Network

哮喘临床研究网络

• 批准号: 6800519
• 负责人: William J Calhoun
• 金额: $ 76.51万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-15 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6800519
• 关键词: antiinflammatory agents; asthma; beta adrenergic agent; bronchodilators; chemokine; clinical research; clinical trials; cooperative study; corticosteroids; drug metabolism; genetic polymorphism; human subject; human therapy evaluation; inhalation drug administration; leukotrienes; patient care management; patient oriented research; pharmacogenetics; respiratory airflow measurement; respiratory disorder chemotherapy; respiratory function; respiratory pharmacology; theophylline; tomography

DESCRIPTION (provided by applicant): This application for an Asthma Clinical Research Network site presents the multitude of strengths which the University of Pittsburgh would bring to the ACRN. Asthma affects more than 14 million Americans, and disproportionately affects African-Americans and Hispanics. Guidelines for asthma management highlight the role of inhaled corticosteroids [ICS] for asthma, based on a large body of literature demonstrating superiority, on average, of ICS over other options, including leukotriene modifiers [LTM]. This recommendation is based on the concept that the majority of asthmatics will improve with ICS. A recent ACRN publication (MICE), however, strongly suggests that response to ICS is neither universal nor uniform. A principal theme of this application is that variability in response to therapy can be identified prospectively, and used to improve the care of patients with asthma. Genetic and metabolic factors underlie variability in clinical response. We propose to measure polymorphisms in genes related to asthma and in drug metabolizing enzymes, to measure functional activity of drug metabolizing enzymes, and to measure clinical response to ICS, LTM, and theophylline in the Determinants in Asthma of Response to Therapy [DART] protocol. We then may be able to use these factors as predictors of positive response to asthma therapy. Another key question is whether LTM, theophylline, or higher dose ICS improve asthma control, especially lung function and rates of exacerbation. This question will be addressed in the Evaluation of Supplemental Therapy for Asthma [ESTA] trial. The University of Pittsburgh offers an existing, productive infrastructure with a track record of productivity in clinical trials in asthma, and an NIH-funded basic and translational research program. We have a large existing cadre of asthma patients, links to the UPMC Health Plan for access to more than 5000 additional asthmatics, and a demonstrated history of recruiting and retaining minority subjects. We offer collaboration with the (Pitt) Center for Minority Health, extremely strong minority recruiting strategies, a strong GCRC, world-class gene expression microarray analysis, an innovative Center for Clinical Pharmacology, including a Clinical Pharmacology Analytic Facility, and a Pharmaco-genomics Core Laboratory. Pitt strongly supports collaborative, clinical network research. Data from the DART and ESTA trials can help to improve the care of patients with asthma.

描述（由申请人提供）：哮喘临床研究网络网站的申请介绍了匹兹堡大学将为ACRN带来的众多优势。 哮喘影响超过1400万美国人，并且不成比例地影响非洲裔美国人和西班牙裔美国人。 哮喘管理指南强调了吸入性皮质类固醇[ICS]在哮喘中的作用，这是基于大量文献，这些文献平均证明了ICS优于其他选择，包括白三烯调节剂[LTM]。 这一建议是基于这样的概念，即大多数哮喘患者将改善与ICS。 然而，ACRN最近的一份出版物（MICE）强烈表明，对ICS的反应既不普遍也不统一。 本申请的一个主要主题是可以前瞻性地识别对治疗反应的变异性，并用于改善哮喘患者的护理。遗传和代谢因素是临床反应变异性的基础。 我们建议测量哮喘相关基因和药物代谢酶的多态性，测量药物代谢酶的功能活性，并在哮喘治疗反应的决定因素[DART]方案中测量对ICS、LTM和茶碱的临床反应。 然后，我们可能能够使用这些因素作为预测哮喘治疗的积极反应。 另一个关键问题是LTM、茶碱或更高剂量的ICS是否能改善哮喘控制，尤其是肺功能和加重率。 这个问题将在哮喘补充治疗评价[ESTA]试验中得到解决。 匹兹堡大学提供现有的生产性基础设施，在哮喘临床试验中具有良好的生产力记录，以及NIH资助的基础和转化研究计划。 我们现有大量哮喘患者，与UPMC健康计划联系，可获得5000多名额外的哮喘患者，并有招募和保留少数民族受试者的历史。 我们与（皮特）少数民族健康中心合作，提供非常强大的少数民族招募策略，强大的GCRC，世界一流的基因表达微阵列分析，创新的临床药理学中心，包括临床药理学分析设施和药物基因组学核心实验室。 Pitt大力支持协作式临床网络研究。 DART和ESTA试验的数据可以帮助改善哮喘患者的护理。