Servicio de Neumología, IISAragón, Hospital Universitario Miguel Servet, Zaragoza, Spain.
CIBER Enfermedades Respiratorias, Madrid, Spain.
Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620963021. doi: 10.1177/1753466620963021.
The IMPACT trial has compared the benefit in the reduction of moderate/severe exacerbations of single inhaler triple therapy (SITT) with fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) dual therapy with FF/VI (ICS/LABA) and UMEC/VI (LAMA/LABA) in the treatment of patients with chronic obstructive disease (COPD). This study performs a subgroup analysis of the cohort from Spain in the IMPACT study.
In IMPACT, a 52-week randomized, double-blind, parallel-group, multicenter study ( = 10,355), patients ⩾40 years of age with COPD and ⩾1 moderate/severe exacerbations in the previous year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25 µg, FF/VI 100/25 µg or UMEC/VI 62.5/25 µg administered via the Ellipta inhaler. Here, we present a subgroup analysis of the 499 patients from Spain, included in the intent-to-treat (ITT) population in the study. Endpoint assessed included exposure-adjusted rate of moderate and severe exacerbations.
In the Spain cohort, the exposure-adjusted rate of on-treatment moderate/severe COPD exacerbations per year for FF/UMEC/VI was 1.31 1.43 and 1.57 for FF/VI and UMEC/VI, respectively. No new adverse events were identified. The results are consistent with those observed in the overall ITT study population.
In the Spain cohort of the IMPACT study, patients receiving triple therapy with FF/UMEC/VI had a lower exposure-adjusted rate of exacerbations compared with FF/VI and UMEC/VI, similar to the overall population. A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease: https://www.clinicaltrialsregister.eu/ctr-search/search?query=CTT116855/ https://clinicaltrials.gov/ct2/show/NCT02164513: GSK (CTT116855/NCT02164513).
IMPACT 试验比较了氟替卡松糠酸酯（FF）/乌美溴铵（UMEC）/维兰特罗（VI）三联单吸入器治疗与 FF/VI（ICS/LABA）和 UMEC/VI（LAMA/LABA）双联治疗慢性阻塞性肺疾病（COPD）患者中中度/重度加重的获益。本研究对 IMPACT 研究中西班牙队列进行了亚组分析。
在 IMPACT 中，一项为期 52 周的随机、双盲、平行组、多中心研究（ = 10355），年龄 ⩾40 岁、前一年有 ⩾1 次中度/重度加重的 COPD 患者按 2:2:1 比例随机分配至每日一次 FF/UMEC/VI 100/62.5/25 μg、FF/VI 100/25 μg 或 UMEC/VI 62.5/25 μg，通过 Ellipta 吸入器给药。在此，我们展示了研究中意向治疗（ITT）人群中来自西班牙的 499 名患者的亚组分析。评估的终点包括治疗中调整后的中度和重度 COPD 加重发生率。
在西班牙队列中，FF/UMEC/VI 的治疗中调整后的每年中度/重度 COPD 加重发生率分别为 1.31 比 1.43 和 1.57 比 FF/VI 和 UMEC/VI。未发现新的不良事件。结果与总体 ITT 研究人群一致。
在 IMPACT 研究的西班牙队列中，接受 FF/UMEC/VI 三联治疗的患者与 FF/VI 和 UMEC/VI 相比，治疗中调整后的加重发生率较低，与总体人群相似。一项为期 52 周、随机、双盲、3 臂平行组研究，比较了氟替卡松糠酸酯/乌美溴铵/维兰特罗固定剂量三联复方与氟替卡松/维兰特罗和乌美溴铵/维兰特罗固定剂量双重组合，均每日一次，在慢性阻塞性肺疾病患者中通过干粉吸入器给药：https://www.clinicaltrialsregister.eu/ctr-search/search?query=CTT116855/https://clinicaltrials.gov/ct2/show/NCT02164513: GSK（CTT116855/NCT02164513）。
