Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.
LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.
Respir Med. 2022 Jun;197:106857. doi: 10.1016/j.rmed.2022.106857. Epub 2022 Apr 22.
In the Phase III ETHOS study (NCT02465567), budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) triple therapy at two inhaled corticosteroid (ICS) doses reduced moderate/severe exacerbation rates and improved symptoms, health-related quality of life (HRQoL), and lung function versus glycopyrronium/formoterol fumarate dihydrate (GFF) or budesonide/formoterol fumarate dihydrate (BFF) dual therapy in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD). Here, we assessed whether the benefit for BGF versus GFF was driven by patients who received ICS before randomization to GFF.
ETHOS was a 52-week, randomized, double-blind, multicenter, parallel-group study in symptomatic patients with COPD and ≥1 moderate/severe exacerbation in the previous year. Patients received BGF 320/14.4/10 μg, BGF 160/14.4/10 μg, GFF 14.4/10 μg, or BFF 320/10 μg twice daily via a single metered dose Aerosphere™ inhaler. In these subgroup analyses, efficacy and safety were assessed in patients with or without prior ICS use in the 30 days before screening.
The modified intent-to-treat population comprised 8509 patients (prior ICS use, n = 6810 [80%]; no prior ICS use, n = 1699 [20%]). Moderate/severe exacerbation rates were reduced by 24% and 23% in patients with and without prior ICS use, respectively, with BGF 320 versus GFF. Benefits of BGF 320 versus GFF were also similar in patients with and without prior ICS use across other endpoints relating to exacerbations, symptoms, HRQoL, lung function, and safety. Trends were similar for BGF 160 versus GFF.
Benefits on exacerbations, symptoms, HRQoL, and lung function with BGF versus GFF were observed, irrespective of prior ICS use in the 30 days before screening.
在 III 期 ETHOS 研究（NCT02465567）中，布地奈德/格隆溴铵/富马酸福莫特罗双水化合物（BGF）三联疗法的两种吸入皮质激素（ICS）剂量降低了中度/重度加重的发生率，并改善了症状、健康相关生活质量（HRQoL）和肺功能，与格隆溴铵/富马酸福莫特罗双水化合物（GFF）或布地奈德/富马酸福莫特罗双水化合物（BFF）双联疗法相比，在中度至重度慢性阻塞性肺疾病（COPD）患者中。在这里，我们评估了与 GFF 相比，BGF 的益处是否是由随机分组前接受 ICS 治疗的患者驱动的。
ETHOS 是一项为期 52 周、随机、双盲、多中心、平行组研究，纳入了有症状的 COPD 患者，这些患者在前一年中有≥1 次中度/重度加重。患者接受 BGF 320/14.4/10μg、BGF 160/14.4/10μg、GFF 14.4/10μg 或 BFF 320/10μg 每日两次，通过单一计量 Aerosphere™吸入器。在这些亚组分析中，在筛选前 30 天内评估了有或没有既往 ICS 使用的患者的疗效和安全性。
意向治疗人群包括 8509 例患者（既往 ICS 使用，n=6810[80%]；无既往 ICS 使用，n=1699[20%]）。与 GFF 相比，既往 ICS 使用患者和无既往 ICS 使用患者的中度/重度加重发生率分别降低了 24%和 23%。在既往 ICS 使用患者和无既往 ICS 使用患者中，BGF 320 与 GFF 相比，其他与加重、症状、HRQoL、肺功能和安全性相关的终点也具有相似的获益。BGF 160 与 GFF 相比，也呈现出相似的趋势。
在筛选前 30 天内有或没有使用 ICS 的情况下，BGF 与 GFF 相比，在加重、症状、HRQoL 和肺功能方面都观察到了获益。
