Abstract：
BACKGROUND: Treatment with LABA/LAMA is recommended in GOLD B patients. We hypothesized that triple therapy (LABA/LAMA/ICS) will be superior to LABA/LAMA in achieving and maintaining clinical control (CC), a composite outcome that considers both impact and disease stability in a subgroup of GOLD B patients (here termed GOLD B+ patients) characterized by: (1) remaining symptomatic (CAT≥10) despite regular LABA/LAMA therapy; (2) having suffered one moderate exacerbation in the previous year; and (3) having blood eosinophil counts (BEC) ≥150cells/μL.
METHODS: The ANTES B+ study is a prospective, multicenter, open label, randomized, pragmatic, controlled trial designed to test this hypothesis. It will randomize 1028 B+ patients to continue with their usual LABA/LAMA combination prescribed by their attending physician or to begin fluticasone furoate (FF) 92μg/umeclidinium (UMEC) 55μg/vilanterol (VI) 22μg in a single inhaler q.d. for 12 months. The primary efficacy outcome will be the level of CC achieved. Secondary outcomes include the clinical important deterioration index (CID), annual rate of exacerbations, and FEV1. Exploratory objectives include the interaction of BEC and smoking status, all-cause mortality and proportion of patients on LABA/LAMA arm that switch therapy arms. Safety analysis include adverse events and incidence of pneumonia.
RESULTS: The first patient was recruited on February 29, 2024; results are expected in the first quarter of 2026.
CONCLUSIONS: The ANTES B+ study is the first to: (1) explore the efficacy and safety of triple therapy in a population of B+ COPD patients and (2) use a composite index (CC) as the primary result of a COPD trial.
METHODS: The ANTES B+ study is a prospective, multicenter, open label, randomized, pragmatic, controlled trial designed to test this hypothesis. It will randomize 1028 B+ patients to continue with their usual LABA/LAMA combination prescribed by their attending physician or to begin fluticasone furoate (FF) 92μg/umeclidinium (UMEC) 55μg/vilanterol (VI) 22μg in a single inhaler q.d. for 12 months. The primary efficacy outcome will be the level of CC achieved. Secondary outcomes include the clinical important deterioration index (CID), annual rate of exacerbations, and FEV1. Exploratory objectives include the interaction of BEC and smoking status, all-cause mortality and proportion of patients on LABA/LAMA arm that switch therapy arms. Safety analysis include adverse events and incidence of pneumonia.
RESULTS: The first patient was recruited on February 29, 2024; results are expected in the first quarter of 2026.
CONCLUSIONS: The ANTES B+ study is the first to: (1) explore the efficacy and safety of triple therapy in a population of B+ COPD patients and (2) use a composite index (CC) as the primary result of a COPD trial.
摘要：
背景：建议在GOLDB患者中使用LABA/LAMA治疗。我们假设三联疗法（LABA/LAMA/ICS）在实现和维持临床控制（CC）方面优于LABA/LAMA。在GOLDB患者亚组(此处称为GOLDB+患者)中考虑影响和疾病稳定性的复合结局,其特征在于:(1)尽管接受常规LABA/LAMA治疗,但仍有症状(CAT≥10);(2)在过去一年中经历过一次中度加重;(3)血液嗜酸性粒细胞计数(BEC)≥150个细胞/μL.
方法：ANTESB+研究是一项前瞻性研究，多中心，开放标签,随机化，务实,旨在检验这一假设的对照试验。它将随机分配1028名B患者，以继续使用其主治医师开具的常规LABA/LAMA组合，或开始使用氟替卡松糠酸酯（FF）92μg/umecidinium（UMEC）55μg/维兰特罗（VI）22μg在单个吸入器q.d中进行12个月。主要疗效结果将是达到的CC水平。次要结果包括临床重要恶化指数（CID），年恶化率，和FEV1。探索目标包括BEC和吸烟状况的相互作用，全因死亡率和LABA/LAMA臂上切换治疗臂的患者比例。安全性分析包括不良事件和肺炎发生率。
结果：首例患者于2024年2月29日招募；结果预计在2026年第一季度。
结论：ANTESB+研究是第一个：（1）探索三联疗法在B+COPD患者人群中的疗效和安全性；（2）使用综合指数（CC）作为COPD试验的主要结果。
方法：ANTESB+研究是一项前瞻性研究，多中心，开放标签,随机化，务实,旨在检验这一假设的对照试验。它将随机分配1028名B患者，以继续使用其主治医师开具的常规LABA/LAMA组合，或开始使用氟替卡松糠酸酯（FF）92μg/umecidinium（UMEC）55μg/维兰特罗（VI）22μg在单个吸入器q.d中进行12个月。主要疗效结果将是达到的CC水平。次要结果包括临床重要恶化指数（CID），年恶化率，和FEV1。探索目标包括BEC和吸烟状况的相互作用，全因死亡率和LABA/LAMA臂上切换治疗臂的患者比例。安全性分析包括不良事件和肺炎发生率。
结果：首例患者于2024年2月29日招募；结果预计在2026年第一季度。
结论：ANTESB+研究是第一个：（1）探索三联疗法在B+COPD患者人群中的疗效和安全性；（2）使用综合指数（CC）作为COPD试验的主要结果。
