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.

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。 这项研究的主要目的是回答这个问题：对于没有接受低剂量吸入皮质类固醇控制的儿童，改善哮喘控制的最佳方法是什么？增加吸入皮质类固醇的剂量？或者，保持吸入的皮质类固醇剂量相同，并添加另一种药物[长效β-激动剂(例如沙美特罗)或白三烯受体拮抗剂(例如Singulair)]？为了回答这个问题，受试者将在整个研究的不同时间服用这三种药物选项中的每一种，以及你每天吸入的皮质类固醇。 FloventDiskus是本研究中将使用的吸入型皮质类固醇。它被食品和药物管理局(FDA)批准用于成人和4岁及以上儿童哮喘，剂量为本研究所使用的剂量。 Singulair是白三烯受体拮抗剂(片剂)，将在本研究中使用。FDA批准了这项研究中使用的剂量用于成人和6岁及以上儿童哮喘的治疗。 Advair Diskus将用于这项研究，它含有长效β-激动剂(沙美特罗)和吸入型皮质类固醇(与FloventDiskus中发现的类型相同)。FDA批准它用于成人和4岁及以上儿童的哮喘。 这项研究的另一个目的是确定哪些身体特征，包括参与者的S基因，可能与对这些哮喘药物的良好或不良反应有关。在随机访问(V2a)期间将采集血样，以帮助寻找这些特征。这些发现可能会增加我们对哮喘和过敏之间可能的联系，以及个人是否会对哮喘药物有反应的理解。参与这项研究需要进行基因分析。大约36名受试者将在国家犹太人学校参加这项研究。共有180名受试者将在全美5个不同地点参与这项研究。