CAMP Continuation Study/Phase 3

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为期4年的额外跟踪(至21-29岁)，以确定表明成年后慢性气流阻塞的肺功能下降模式的临床和遗传风险因素。没有其他关于儿童哮喘的研究有确定这些危险因素所需的规模、详细的表型和纵向随访。CAMP招募了1041名持续性哮喘患者，以确定定期吸入皮质类固醇(ICS)对肺生长的影响。我们目前正在跟踪869例(原始队列的83%)，以确定持续性哮喘患者在成年期早期达到最大肺生长的预测因素。我们已经确定了生长减少和演变的呼吸道阻塞的模式。对23岁或23岁以上的cAMP参与者的分析表明，28%的人即使在支气管扩张后也没有达到正常的FEV1最大水平。我们还观察到，20%的人已经开始下降，平均下降年龄为19.4岁。这些异常可能是由于提示早期慢性阻塞性肺疾病的持续性炎症所致。我们提出了3个具体目标：1)使用一系列正常的比较人群，确定持续的儿童哮喘患者的易感亚群，这些患者面临获得的最大肺功能降低和随后的肺功能下降的模式的风险；2)确定最大获得的肺功能和早期肺功能下降的遗传相关性(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，这一应用不收费)，将700多名父母和CAMP患者的现有遗传数据与在CAMP所有阶段收集的详细表型数据联系起来，以及3)确定持续使用吸入性抗炎药物治疗4-6年至成年早期的效果。肺活量测定的数据收集程序和其他程序将与CAMP研究的前几阶段使用的程序相同。每年一次的支气管扩张剂治疗前和治疗后的肺活量测定将有助于准确测量肺功能。CAMP是规模最大、特征最全面的哮喘儿童队列。在CAMPCS/3中对这一队列的随访将提供关于这种重要的儿童肺部疾病的自然病史的宝贵信息，这些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。)

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.)