CAMP Continuation Study Phase 2 (CAMPCS / 2)

CAMP 继续研究第二阶段 (CAMPCS / 2)

• 批准号: 7095111
• 负责人: Robert Strunk
• 金额: $ 24.97万
• 依托单位: WASHINGTON UNIVERSITY
• 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 2007-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7095111
• 关键词: adolescence (12-20); asthma; body height; bone density; bronchodilators; clinical research; cooperative study; corticosteroids; developmental genetics; drug adverse effect; eosinophilia; human subject; human therapy evaluation; inhalation drug administration; interleukin 10; longitudinal human study; outcomes research; pathologic process; patient oriented research; respiratory disorder chemotherapy; respiratory function; single nucleotide polymorphism; smoking; spirometry; toll like receptor; young adult human (21-34)

DESCRIPTION (provided by applicant): Childhood asthma can result in significant lung disease in adulthood and possibly the development of COPD. None of the long-term follow-up studies of childhood asthma have had the close follow-up needed to define determinants of outcomes in young adulthood. No study has examined the effects of intensive treatment with potent anti-inflammatory agents on outcomes. CAMP was a multicenter randomized clinical trial designed to determine the effects of three treatments (albuterol alone, albuterol with inhaled corticosteroid [ICS], albuterol with inhaled non-steroid) in 1,041 children (randomized at ages 5-12 years) with mild to moderate asthma on pulmonary function during a 3.5-5.5 year treatment phase. The cohort is being followed currently in a 4-year observational phase (CAMP Continuation Study, CAMPCS) to determine longer-term effects of the treatments on lung and somatic growth. 88% of the original cohort enrolled, with a missed visit rate of less than 1%. At the scheduled end of CAMPCS, only 70% of females and 38% of males will have achieved an age of likely maximal height and level of pulmonary function. Additional follow-up of the CAMP cohort, CAMPCS/2, is designed to follow the cohort for 4 additional years into early adulthood, when the patients will be 17-26 years (55% >greater than or equal too 21 years). We propose 5 specific aims. We will determine the effects of 3.5-5.5 years of ICS therapy started at ages 5 to 12 years on outcomes of pulmonary function, height, bone density, and the clinical course of asthma in young adulthood. Natural history aims will focus on 1) effects of lower respiratory symptoms, allergy, peripheral blood eosinophilia, and personal smoking on attained level lung function FEV1, FVC, FEV1/FVC) and airway reactivity in young adulthood, 2) effects of lung function, airway reactivity, allergy, peripheral blood eosinophilia, and personal smoking on lower respiratory symptoms in young adulthood, and 3) factors associated with a low FEV1/FVC ratio by comparison of FEV1/FVC and FEV1 and FVC in CAMP patients to three sets of pulmonary function values from normal. Genetic analyses will be done by Dr. Weiss and the Center for Genetics and Genomics at Harvard (without cost to this application) with comparison of the genetic data to the phenotypic data collected during CAMP, CAMPCS, and CAMPCS/2 will allow definitive determination of effect of ICS on these measures. CAMP is the largest and most completely characterized group of children with asthma. Follow-up of this cohort for another 4 years in CAMPCS/2 will provide valuable information about the natural history of this important childhood lung disease, and information on how the childhood illness affects adult lung health.

描述（由申请人提供）： 童年哮喘可能导致成年后的肺部疾病，可能导致COPD的发展。 对儿童哮喘的长期随访研究都没有进行定义成年后结果决定因素所需的紧密随访。 没有研究检查有效抗炎药对结局的强化治疗的影响。 CAMP是一项多中心随机临床试验，旨在确定三种治疗方法（单独的白化醇，紫but醇，具有吸入的皮质类固醇[ICS]，Albuterol，具有吸入非甾体类固醇的Albuterol）在1,041名儿童中（5-12岁的5-12岁随机分配），并在3.5-5-5.5-5-5.5-5-5.5-5.5-5-5.5-5-5.5年期间对肺炎中度适度的肺部功能进行了轻度。 该队列目前正在遵循4年的观察阶段（CAMP连续研究，CAMPCS），以确定治疗对肺部和躯体生长的长期影响。 原始人群中有88％的访问率不到1％。 在CAMCC的预定末端，只有70％的女性和38％的男性将达到可能达到最大身高和肺功能水平的年龄。 营地队列（CAMCCS/2）的额外随访旨在跟随该队列在成年后4年，届时患者将达到17-26岁（55％> 55％>大于或相等21岁）。 我们提出了5个具体目标。 我们将确定5至12岁的ICS疗法的3.5 - 5.5年疗法对肺功能，身高，骨密度和临床哮喘成年后的临床疗程的结果。 Natural history aims will focus on 1) effects of lower respiratory symptoms, allergy, peripheral blood eosinophilia, and personal smoking on attained level lung function FEV1, FVC, FEV1/FVC) and airway reactivity in young adulthood, 2) effects of lung function, airway reactivity, allergy, peripheral blood eosinophilia, and personal smoking on lower respiratory symptoms in young成年和3）与FEV1/FVC比率低的因素相关的因素，通过比较CAMP患者的FEV1/FVC和FEV1和FVC与正常患者的三组肺功能值。 遗传分析将由魏斯博士和哈佛大学的遗传学和基因组学中心（无代价）与将遗传数据与在营地，CAMPC和CAMPC/CACKC/2收集的表型数据进行比较，将允许对这些度量的效果确定确定性确定。 营地是哮喘儿童最大，最完全有特征的儿童。 在CAMCC/2中对这一队列的后续进行了4年的跟进将提供有关这种重要儿童肺部疾病的自然史的宝贵信息，以及有关儿童疾病如何影响成人肺部健康的信息。