Effectiveness of Low-dose Theophylline for the Management of biomass-associated COPD

低剂量茶碱治疗生物质相关慢性阻塞性肺病的有效性

基本信息

批准号：
10415226
负责人：
Trishul Siddharthan
金额：
$ 19.63万
依托单位：
UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-07-15 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10415226
关键词：
Adrenal Cortex Hormones Adult Age Agricultural Crops Albuterol Altitude Anti-Inflammatory Agents Attenuated Award Benchmarking Biological Markers Biomass Biometry Body mass index Bronchodilator Agents Cardiovascular Diseases Cause of Death Cessation of life Chronic Chronic Disease Chronic Obstructive Pulmonary Disease Clinical Trials Clinical effectiveness Coal Communities Comparative Effectiveness Research Data Diabetes Mellitus Disease Doctor of Medicine Dose Down-Regulation Effectiveness Epidemiology Evaluation Fibrinogen Forced expiratory volume function Frequencies Funding Genes Genetic Transcription Goals Health Health Status Heating Histopathology Hour Household Air Pollution Income Individual Inflammation Inflammatory Inhalation Intervention K-Series Research Career Programs Lung diseases Measurement Measures Mediating Medical Mentors Mentorship Modeling Outcome Outcome Study Pathogenesis Persons Peru Peruvian Pharmacotherapy Phenotype Placebos Population Study Prognosis Quality-Adjusted Life Years Questionnaires Randomized Randomized Controlled Trials Regimen Research Research Personnel Respiratory Signs and Symptoms Risk Factors Scientist Serum Theophylline Tobacco Training United States National Institutes of Health Urbanization Wood material arm base biomass fuel career chronic respiratory disease cohort cooking cost cost effective cost effective intervention cost effectiveness cost estimate cost-effectiveness ratio economic evaluation effective therapy effectiveness evaluation effectiveness implementation study effectiveness testing experience follow-up functional disability group intervention health care service utilization health related quality of life improved incremental cost-effectiveness instrument longitudinal analysis low and middle-income countries markov model mid-career faculty multidisciplinary patient oriented research pilot trial primary outcome professor pulmonary function pulmonary function decline respiratory sex side effect skills socioeconomics solid fuel standard care treatment response wasting willingness to pay

项目摘要

PROJECT SUMMARY/ABSTRACT This is an application for the K23 Mentored Patient-Oriented Research Career Scientist Award for Trishul Siddharthan M.D. Dr. Siddharthan has shown great promise as a young investigator, and has experience conducting research in epidemiology and chronic disease in low- and middle-income countries (LMICs). However, he is now proposing to gain advanced training in conducting longitudinal analysis and randomized controlled trials requires additional training and mentorship to do so. His overall career goal is to become an independent investigator and expert in evaluating the effectiveness medical therapies for chronic respiratory diseases, and this award will provide Dr. Siddharthan with the support and training to accomplish this goal. He has assembled an experienced mentorship team including: Dr. William Checkley (Primary Mentor, Chronic Respiratory Diseases), Associate Professor (JHU); Dr. Robert Wise (Clinical Trials), Professor (JHU); Dr. James Tonascia (Biostatistics), Professor (JHU); and Dr. David Dowdy (Cost-evaluation), Associate Professor (JHU). Through a combination of close mentorship, formal coursework, and practical experience, Dr. Siddharthan proposes to accomplish the following training goals: 1) Advanced training in longitudinal analysis; 2) Advanced training in randomized controlled trials; and 3) Advanced training in cost-evaluation. Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide, and over 90% of COPD-related deaths occurring in low- and middle-income countries (LMICs). Household air pollution (HAP) – from burning solid fuels such as wood, dung, agricultural crop waste, and coal for energy – is the primary risk factor for COPD in these settings. Biomass-related COPD has a distinct histopathology, phenotype and inflammatory profile when compared to tobacco mediated COPD. Despite the high global burden of biomass- related disease, little is known about the effectiveness of pharmacotherapies for biomass-related COPD; to date, no clinical trials have focused specifically on treatment of biomass-related COPD. Dr. Siddharthan proposes to assess the health impact of biomass-related COPD and test the effectiveness of low dose theophylline compared to standard therapy among adults with biomass-related COPD in Peru. He proposes to assess whether low-dose theophylline improves respiratory symptoms, decreases the inflammatory profile of serum biomarkers and whether administration attenuates the effect of HAP on lung function. He additionally aims to assess whether low-dose theophylline is a cost-effective intervention based on the incremental cost- effectiveness ratio and a range of willingness to pay thresholds. Results from this study will generate preliminary data to compete for an R01-level award to conduct an implementation-effectiveness hybrid trial in multiple communities to assess the impact of chronic pharmacotherapy for biomass-related COPD.

项目摘要/摘要这是K23指导的以患者为导向的研究职业科学家Trishul的申请 Siddharthan M.D. Siddharthan博士在年轻的研究员中表现出了很大的希望，并且有经验低收入和中等收入国家（LMIC）在流行病学和慢性疾病方面进行研究。但是，他现在建议在进行纵向分析和随机分析方面获得高级培训对照试验需要额外的培训和心态。他的整体职业目标是成为一个独立研究者和专家评估慢性呼吸系统的有效性医疗疗法疾病，该奖项将为Siddharthan博士提供支持和培训，以实现这一目标。他已经组建了一个经验丰富的心态团队，其中包括：威廉·奇克利（William Checkley）博士（主要导师，慢性呼吸道疾病），副教授（JHU）；罗伯特·怀斯（Robert Wise）博士（临床试验），教授（JHU）；博士 James Tonascia（生物统计学），教授（JHU）；副教授David Dowdy博士（成本评估）（jhu）。通过仔细的心态，正式课程和实践经验的结合，博士 Siddharthan的提议要实现以下培训目标：1）纵向分析的高级培训； 2）随机对照试验的高级培训； 3）成本评估的高级培训。慢性阻塞性肺疾病（COPD）是全球第四大死亡原因，超过90％在低收入和中等收入国家（LMIC）发生与COPD相关的死亡。家庭空气污染（HAP） - 燃烧固体燃料，例如木材，粪便，农作物废物和能源煤 - 是主要风险在这些设置中COPD的因素。与生物质相关的COPD具有独特的组织病理学，表型和与烟草介导的COPD相比，炎症性特征。尽管存在生物质的全球负担很高 - 相关疾病，关于药物治疗对生物质相关COPD的有效性知之甚少。日期，没有专门针对生物质相关COPD的临床试验。 Siddharthan博士提出评估生物质相关COPD的健康影响并测试低剂量有效性的建议菲林与秘鲁与生物质相关COPD的成年人的标准疗法相比。他提出评估低剂量的phyllline是否改善了呼吸症状，减少了血清生物标志物以及给药是否会减弱HAP对肺功能的影响。他另外旨在评估低剂量phyllline是否是基于增量成本的成本效益的干预措施有效性比率和一系列支付门槛的意愿。这项研究的结果将产生初步数据竞争R01级奖励，以进行实施效果混合试验多个社区评估慢性药物治疗对生物质相关COPD的影响。