THE STUDY OF ACID REFLUX IN CHILDREN WITH ASTHMA

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 与服用安慰剂的儿童相比，患有症状性哮喘的儿童通过使用质子泵抑制剂兰索拉唑对食道反流进行药物治疗，改善了哮喘的控制。这将是一项多地点、随机、双掩蔽、安慰剂对照、平行组的临床试验。300名儿童将被随机分配到两个治疗组中的一个：口服兰索拉唑或口服安慰剂，为期24周。主要的结果衡量标准是治疗过程中急性冠脉综合征的显著变化。次要结果包括肺功能、哮喘控制不佳的次数、哮喘症状、哮喘相关症状，将在随机分组之前通过食道pH监测对一组参与者进行评估。GERD的严重程度、频率和与哮喘症状的关系将在随机分组之前通过食道pH监测进行评估。V1为筛查访问，V2为随机访问，V3为临时电话访问，V4-V9为每月数据收集访问。参与者将被要求记录每天的哮喘症状、每天早上的呼气峰值流量、因哮喘而在夜间醒来、哮喘治疗和医疗保健使用情况。参与者将完成关于健康和哮喘史、哮喘症状和日常活动、与受试者哮喘相关的生活质量以及胃部症状的问卷调查。肺功能测试包括乙酰甲胆碱激发、肺活量测定、呼出的呼吸冷凝物和一氧化氮。可选的胃酸反流测试是一种24小时的pH探头，参与者将通过鼻子插入探头/管子并向下插入胃部，以测量胃酸结果。将有两次抽血，一次用于测试研究药物水平，第二次用于DNA分析。受试者将被分配为在24周内每天服用质子泵抑制剂兰索拉唑或安慰剂。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Children with symptomatic asthma have improved asthma control with medical treatment of esophageal reflux with the proton-pump inhibitor, lansoprazole, as compared to children treated with placebo. This will be a multi-site, randomized, double-masked, placebo-controlled, parallel group clinical trial. Three hundred children will be randomly assigned to one of two treament groups: oral lansoprazole or oral placebo for 24 weeks. The primary outcome measure is a significant change in the ACS during treatment. Secondary outcomes include lung function, episodes of poor asthma control, asthma symptoms, asthma-related symptoms will be evaluated by esophageal pH monitoring in a subset of participants prior to randomization. GERD severity, frequency, and relationship to asthma symptoms will be evaluated by esophageal pH monitoring in a subset of participants prior to randomization. V1 is the screening visit, V2 is the randomization visit, V3 is an interim phone visit, and V4-V9 are monthly data collection visits. Participants will be asked to record daily asthma symptoms, daily morning peak expiratory flow, awakenings at night because of asthma, asthma treatments, and healthcare use. Participants will complete questionnaires concerning health and asthma history, asthma symptoms and daily activities, quality of life as it relates to the subject's asthma, and stomach symptoms. Lung function tests include methacholine challenge, spirometry, exhaled breath condensate, and nitric oxide. The optional acid reflux test is a 24 hour pH probe where the participant will have a probe/tube inserted through the nose and down into the stomach to measure acid outcome. There will be 2 blood draws, one to test study drug level, and the second for DNA analysis. The subject will be assigned to take either lansoprazole, a proton pump inhibitor, or placebo on a daily basis for 24 weeks.