BELT: Blacks & Exacerbations on LABA vs. Tiotropium

描述（由申请人提供）：黑人在哮喘发病率和死亡率方面承担着不成比例的负担。在其2005年关于医疗保健中的种族差异的报告中，AHRQ确定哮喘住院是黑人与白人之间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，是一类作用于ADRB 2的药物，即使与ICS联合使用，也会导致罕见的长期哮喘控制丧失和严重不良结局增加，包括死亡和呼吸衰竭。黑人哮喘患者的风险似乎比非黑人哮喘患者高出四到五倍。在黑人中使用LABA/ICS的研究与黑人占少数的研究相比，表明黑人的获益可能比其他种族群体少得多。此外，最近的数据（Wechsler 2009）表明，ADRB 2基因第16位的多态性鉴定了一组黑人（精氨酸（Arg 16 Arg）纯合型），其中将LABA添加至ICS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，提出了一项研究，以确定在一项为期一年的基于实践的、真实世界的、随机的、前瞻性的、平行组的、纵向的比较有效性试验中，是否在自认为患有哮喘的黑人患者中，LABA/ICS治疗上级优于非2-肾上腺素能支气管扩张剂（噻托溴铵）联合ICS（Tio/ICS）。本研究还旨在确定在20%自我确认的携带ADRB 2 Arg 16 Arg的黑人哮喘患者中，LABA/ICS治疗是否上级优于使用非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，为350万黑人哮喘患者提供基于证据的个性化治疗方案和潜在的替代治疗建议。这项研究在真实的生活初级保健环境中的表现将加速将这些发现转化为这一少数人群的日常实践，这些人群经历了不成比例的哮喘负担，并且在以前的哮喘研究中代表性不足。

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.