BEST ADD-ON THERAPY GIVING EFFECTIVE RESPONSES (BADGER)

给出有效反应的最佳附加疗法 (BADGER)

• 批准号: 7719408
• 负责人: Stanley J Szefler
• 金额: $ 1.12万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719408
• 关键词: 4 year old; 6 year old; Adrenal Cortex Hormones; Adult; Advair; Age; Agonist; Asthma; Blood specimen; Breathing; Child; Computer Retrieval of Information on Scientific Projects Database; Daily; Dose; Enrollment; Flovent; Funding; Genes; Grant; Hypersensitivity; Individual; Institution; Leukotriene Antagonists; Link; Pharmaceutical Preparations; Purpose; Randomized; Research; Research Personnel; Resources; Salmeterol; Site; Source; Tablets; Time; United States; United States Food and Drug Administration; United States National Institutes of Health; Visit; follower of religion Jewish; genetic analysis; improved; research study; response

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. The main purpose of this study is to answer this question: What is the best way to improve asthma control in children who are not controlled on low-dose inhaled corticosteroids? Increase the dose of inhaled corticosteroid? Or, keep the inhaled corticosteroid dose the same and add another medication [long acting beta-agonist (e.g. salmeterol) or a leukotriene receptor antagonist (e.g. (Singulair¿¿)]? To answer this question, subjects will take each one of these three medication options, along with your daily inhaled corticosteroid, at different times throughout the study. Flovent Diskus¿¿ is the inhaled corticosteroid that will be used in this study. It is approved by the Food and Drug Administration (FDA) for asthma in adults and children age 4 years and older at the dose used in this study. Singulair¿¿ is the leukotriene receptor antagonist (tablet) that will be used in this study. It is approved by the FDA for asthma in adults and children age 6 years and older at the dose used in this study. Advair Diskus¿¿, which contains a long-acting beta-agonist (salmeterol) and an inhaled corticosteroid (same type as found in Flovent Diskus¿¿), will be used for this study. It is FDA approved for asthma in adults and children age 4 years and older. Another purpose of the research study is to determine what body features, including a participant¿??s genes, may be linked with either a good or poor response to each of these asthma medications. A blood sample will be taken during the randomization visit (V2a) to help look for these features. These findings may increase our understanding of the possible link between asthma and allergies and whether an individual will or will not respond to an asthma medication. A genetic analysis is required to participate in this study. Approximately 36 subjects will be enrolling in this study at National Jewish. A total of 180 subjects will be participating in the study at 5 different sites across the United States.

该副本是使用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这是调查员的机构。 这项研究的主要目的是回答这个问题：改善未经低剂量遗传性皮质类固醇的儿童哮喘控制的最佳方法是什么？增加遗传性皮质类固醇的剂量？或者，保持遗传的皮质类固醇剂量相同，并添加另一种药物（例如，长时间表演β-阳性剂（例如Salmeterol）或白细胞受体受体拮抗剂（例如（Singulair®）]？要回答这个问题，主题会在这三种药物方面中的每一种，以及您每天的每日cortionicastericosteric of Corticosteric of Corticasteric inters thers thers thers thers thers thers thers thers thers thers thers thers thers the Bress inters the rysevers。 Flovent圆盘是本研究中将使用的遗传性皮质类固醇。在本研究中使用的剂量下，它已获得食品药物管理局（FDA）的哮喘批准。 Singulair``是白细胞受体拮抗剂（片剂），将在本研究中使用。在本研究中使用的剂量下，FDA批准了FDA的成人和6岁及6岁以上儿童的哮喘。 该研究将用于本研究，其中包含长效的β-激动剂（Salmeterol）和遗传性皮质类固醇（与FloventDiskus®相同的类型），该研究将用于本研究。在4岁及以上的成人和儿童中，它已获得FDA批准哮喘。 研究研究的另一个目的是确定哪些身体特征，包括参与者的基因，可能与对每种哮喘药物的良好反应或不良反应有关。在随机访问（V2A）期间将采集血液样本，以帮助寻找这些功能。这些发现可能会增加我们对哮喘和过敏之间可能联系的理解，以及个人是否会对哮喘药物反应。需要进行遗传分析才能参与这项研究。在国家犹太人的这项研究中，大约有36名受试者将入学。总共有180名受试者将参加美国5个不同地点的研究。