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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的主要目的是回答这样一个问题：什么是改善小剂量吸入性皮质类固醇不能控制哮喘的儿童的最佳方法？增加吸入性皮质类固醇的剂量？或者，保持吸入皮质类固醇剂量不变，并添加另一种药物[长效β-受体激动剂（如沙美特罗）或白三烯受体拮抗剂（如顺尔宁）]？为了回答这个问题，受试者将在整个研究期间的不同时间服用这三种药物中的每一种，沿着每日吸入性皮质类固醇。 本研究将使用的吸入性皮质类固醇为Flovent ®。美国食品药品监督管理局（FDA）批准本研究中使用的剂量用于成人和4岁及以上儿童的哮喘。 顺尔宁是本研究将使用的白三烯受体拮抗剂（片剂）。FDA批准其用于成人和6岁及以上儿童的哮喘，剂量为本研究所用。 Advair Padulus本研究将使用含有长效β受体激动剂（沙美特罗）和吸入性皮质类固醇（与Flovent β受体激动剂中发现的类型相同）的药物。它是FDA批准用于成人和4岁及以上儿童的哮喘。 研究的另一个目的是确定什么样的身体特征，包括参与者？？这些基因可能与对这些哮喘药物的良好或不良反应有关。 将在随机化访视（V2 a）期间采集血液样本，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联系的理解，以及个体是否会对哮喘药物产生反应。参与本研究需要进行遗传分析。约36例受试者将在National Jewish入组本研究。 共有180例受试者将在美国5个不同的研究中心参加本研究。