BELT: Blacks & Exacerbations on LABA vs. Tiotropium

腰带：黑人

• 批准号: 8010155
• 负责人: Elliot Israel
• 金额: $ 717.75万
• 依托单位: HARVARD CLINICAL RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2013-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8010155
• 关键词: BELT; Blacks; Exacerbations; LABA; vs.

DESCRIPTION (provided by applicant): Blacks bear a disproportionate burden of asthma morbidity and mortality. In its 2005 report on ethnic disparities in health care, AHRQ identified hospital admissions for asthma as the second largest disparity in quality of health care for Blacks versus Whites. Long-acting beta-agonists (LABAs), a popular treatment option for asthma, are in a class of drugs acting at ADRB2, which have been associated with rare loss of long-term asthma control and increased serious adverse outcomes including death and respiratory failure, even when used with ICS. The risk appears to be four to five-folds greater in Blacks than non-Black patients with asthma. Comparison of studies with LABA/ICS in Blacks versus studies where Blacks were a small minority suggests that Blacks may have much less benefit than other racial groups. Additionally, recent data (Wechsler 2009) suggest that a polymorphism at the 16th position of the ADRB2 gene identifies a group of Blacks (those homozygous for arginine (Arg16Arg)) in whom the response of adding a LABA to an ICS is further diminished. This polymorphism is present in ~20% of U.S. Blacks. In order to address the resulting knowledge gaps, a study is proposed to determine, in a one year practice-based, real-world, randomized, prospective, parallel group, longitudinal comparative effectiveness trial with the clinically important primary outcome of asthma exacerbations, whether in self-identified Black patients with asthma, treatment with LABA/ICS is superior to use of a non-2-adrenergic bronchodilator (tiotropium) combined with ICS (Tio/ICS). The study will also aim to determine, whether in the 20% of self-identified Black patients with asthma bearing Arg16Arg of ADRB2, treatment with LABA/ICS is superior to use of a non-2-adrenergic bronchodilator combined with ICS. PUBLIC HEALTH RELEVANCE: The results of this study will provide the information necessary to make evidence-based, individualized, recommendations concerning treatment algorithms and potential alternative treatment recommendations for the 3.5 million Blacks with asthma. The performance of this study in real life primary care settings will hasten the translation of these findings into day to day practice for this minority population that experiences a disproportionate burden of asthma and has been underrepresented in previous asthma studies.

描述（由申请人提供）：黑人承担着不成比例的哮喘发病率和死亡率负担。 AHRQ 在 2005 年关于医疗保健种族差异的报告中指出，因哮喘入院是黑人与白人医疗保健质量的第二大差异。长效 β 受体激动剂 (LABA) 是一种流行的哮喘治疗选择，属于一类作用于 ADRB2 的药物，该药物与罕见的哮喘长期失控以及增加严重不良后果（包括死亡和呼吸衰竭）有关，即使与 ICS 一起使用。黑人哮喘患者的患病风险似乎是非黑人哮喘患者的四到五倍。将 LABA/ICS 在黑人中进行的研究与黑人占少数的研究进行比较表明，黑人获得的益处可能比其他种族群体要少得多。此外，最近的数据（Wechsler 2009）表明，ADRB2 基因第 16 位的多态性识别出一组黑人（精氨酸 (Arg16Arg) 纯合子），其中向 ICS 添加 LABA 的反应进一步减弱。这种多态性存在于约 20% 的美国黑人中。为了解决由此产生的知识差距，建议进行一项研究，以确定在为期一年的基于实践的、现实世界的、随机的、前瞻性的、平行组的纵向比较有效性试验中，以哮喘急性发作的临床重要主要结果，是否在自认患有哮喘的黑人患者中，使用 LABA/ICS 治疗优于使用非 2-肾上腺素能支气管扩张剂（噻托溴铵）联合 ICS (Tio/ICS)。该研究还旨在确定，在 20% 的自认患有 ADRB2 Arg16Arg 的黑人哮喘患者中，使用 LABA/ICS 治疗是否优于使用非 2-肾上腺素能支气管扩张剂联合 ICS。 公共卫生相关性：这项研究的结果将提供必要的信息，以便为 350 万患有哮喘的黑人提出有关治疗算法和潜在替代治疗建议的循证、个性化建议。这项研究在现实生活中的初级保健环境中进行，将加速将这些发现转化为少数群体的日常实践，这些群体经历着不成比例的哮喘负担，并且在之前的哮喘研究中代表性不足。