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受着不成比例的负担。AHRQ在其2005年关于医疗保健中种族差异的报告中指出，因哮喘住院是黑人与白人在医疗保健质量方面的第二大差距。长效β-激动剂(LABA)是一种流行的哮喘治疗药物，属于ADRB2类药物，即使与ICS一起使用，也会罕见地失去长期哮喘控制，并增加包括死亡和呼吸衰竭在内的严重不良后果。黑人哮喘的风险似乎是非黑人哮喘患者的四到五倍。与LABA/ICS在黑人中的研究相比较，黑人是少数族裔的研究表明，黑人可能比其他种族群体受益要少得多。此外，最近的数据(Wechsler 2009)表明，ADRB2基因第16位的多态识别了一组黑人(那些精氨酸(Arg16Arg)纯合子)，在这些黑人中，向ICS添加LABA的反应进一步减弱。这种多态存在于大约20%的美国黑人身上。为了解决由此产生的知识差距，建议进行一项研究，以确定在一年的基于实践的、真实的、随机的、前瞻性的、平行的组纵向比较有效性试验中，对于具有临床重要性的哮喘加重的主要结果，在自认为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(硫托溴铵)联合ICS(Tio/ICS)。这项研究还将旨在确定，在20%携带Arg16Arg ADRB2的自认为患有哮喘的黑人患者中，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，为350万患有哮喘的黑人提供基于证据的、个性化的关于治疗算法和潜在替代治疗建议的建议。这项研究在现实生活中的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群体的日常实践，这些少数群体经历了不成比例的哮喘负担，在以前的哮喘研究中一直被低估。

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.