CAMP Continuation Study/Phase 3

CAMP 继续研究/第 3 阶段

• 批准号: 7364372
• 负责人: ROBERT S ZEIGER
• 金额: $ 15.91万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7364372
• 关键词: Adrenal Cortex Hormones; Adult; Age; Anti-Inflammatory Agents; Anti-inflammatory; Asthma; Breathing; Bronchodilation; Bronchodilator Agents; Child; Childhood; Childhood Asthma; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Clinical; Data; Data Collection; Genetic; Genomics; Growth; Inflammation; Lung; Lung diseases; Measurement; Measures; Natural History; Normal Range; Parents; Participant; Patients; Pattern; Pharmaceutical Preparations; Phase; Phase III Clinical Trials; Phenotype; Population; Procedures; Pulmonary Function Test/Forced Expiratory Volume 1; Recruitment Activity; Respiratory physiology; Risk; Risk Factors; Spirometry; Subgroup; abstracting; aged; airway obstruction; cohort; cost; design; end of life; follow-up; genetic analysis; genetic risk factor; programs; size

DESCRIPTION (provided by applicant): CAMPCS/3 is designed to follow patients with persistent asthma from the Childhood Asthma Management Program (CAMP) trial for 4 additional years (through ages 21-29) to determine clinical and genetic risk factors for patterns of lung function decline indicative of chronic airflow obstruction in later adulthood. No other study of childhood asthma has the size, detailed phenotyping, and longitudinal follow-up needed to determine these risk factors. CAMP recruited 1041 persistent asthmatics to determine the effect of regular inhaled corticosteroid (ICS) on lung-growth. We are currently following 869 (83% of the original cohort) to determine predictors of attained maximal lung growth in early adulthood for persistent asthmatics. We have identified patterns of reduced growth arid evolving airway obstruction. Analysis of CAMP participants, aged 23 years or older, indicate that 28% did not reach normal maximal level of FEV1 even when measured after bronchodilation. We have also observed that 20% have already started to decline, with the mean age of decline 19.4 years. These abnormalities may be due to persistent inflammation suggestive of early chronic obstructive pulmonary disease. We propose 3 specific aims: 1) Define, using a range of normal comparison populations, susceptible subgroups of patients with persistent childhood asthma who are at risk for patterns of reduced attained maximal lung function and of subsequent decline of lung function, 2) Identify genetic correlates of maximal attained lung function and early lung function decline (genetic analyses will be done by Dr. Weiss and the Center for Genetics and Genomics at Harvard, without cost to this application) relating existing genetic data on more than 700 trios of parents and CAMP patients to the detailed phenotypic data collected during all phases of CAMP, and 3) Determine effects into early adulthood of 4-6 years of prior continuous treatment with inhaled anti-inflammatory medications. Data collection procedures for spirometry and other procedures will be identical to those used in previous phases of the CAMP study. Annual pre- and post-bronchodilator spirometry will allow accurate measurement of lung function. CAMP is the largest, most completely characterized cohort of children with asthma. Follow-up of this cohort in CAMPCS/3 will provide valuable information about the natural history of this important childhood lung disease, which can be used to identify patients with asthma who are at risk of chronic airflow obstruction later in adult life. (End of Abstract.)

描述（由申请人提供）： CAMPCS/3 旨在对儿童哮喘管理计划 (CAMP) 试验中的持续性哮喘患者进行额外 4 年（21-29 岁）的跟踪，以确定指示慢性气流阻塞的肺功能下降模式的临床和遗传风险因素在成年后期。没有其他儿童哮喘研究具有确定这些危险因素所需的规模、详细的表型分析和纵向随访。 CAMP 招募了 1041 名持续性哮喘患者来确定定期吸入皮质类固醇 (ICS) 对肺部生长的影响。我们目前正在追踪 869 名患者（占原始队列的 83%），以确定持续性哮喘患者在成年早期达到最大肺部生长的预测因素。我们已经确定了生长减少和气道阻塞不断发展的模式。对年龄 23 岁或以上的 CAMP 参与者的分析表明，即使在支气管扩张后进行测量，28% 的人也没有达到 FEV1 的正常最大水平。我们还观察到，20%的人已经开始衰退，平均衰退年龄为19.4岁。这些异常可能是由于持续炎症引起的，提示早期慢性阻塞性肺病。我们提出了 3 个具体目标：1) 使用一系列正常比较人群，定义持续性儿童哮喘患者的易感亚组，这些患者有最大肺功能下降和随后肺功能下降模式的风险，2) 识别遗传因素达到的最大肺功能和早期肺功能下降的相关性（遗传分析将由 Weiss 博士和哈佛大学遗传学和基因组学中心进行，本申请无需支付费用）将 700 多个三人组的现有遗传数据相关联父母和 CAMP 患者在 CAMP 各个阶段收集的详细表型数据，以及 3) 确定先前持续吸入抗炎药物治疗 4-6 年对成年早期的影响。肺活量测定法和其他程序的数据收集程序将与 CAMP 研究之前阶段使用的相同。每年进行支气管扩张剂使用前和使用后肺活量测定可以准确测量肺功能。 CAMP 是规模最大、特征最完整的哮喘儿童队列。 CAMPCS/3 中该队列的随访将提供有关这种重要儿童肺部疾病自然史的宝贵信息，可用于识别成年后有慢性气流阻塞风险的哮喘患者。 （摘要结束。）