慢性阻塞性肺疾病患者的每日一次三联疗法：患者报告的症状和生活质量。
Once-Daily Triple Therapy in Patients with COPD: Patient-Reported Symptoms and Quality of Life.
机构信息
Value Evidence and Outcomes, GSK, Stockley Park, UK.
UCL Respiratory, University College London, London, UK.
出版信息
Adv Ther. 2018 Jan;35(1):56-71. doi: 10.1007/s12325-017-0650-4. Epub 2018 Jan 8.
INTRODUCTION
Directly recorded patient experience of symptoms and health-related quality of life (HRQoL) can complement lung function and exacerbation rate data in chronic obstructive pulmonary disease (COPD) clinical studies. The FULFIL study recorded daily symptoms and activity limitation together with additional patient-reported outcomes of dyspnea and HRQoL, as part of the prespecified analyses. FULFIL co-primary endpoint data have been previously reported.
METHODS
FULFIL was a phase III, 24-week, randomized, double-blind, double-dummy, multicenter study comparing once-daily single inhaler triple therapy [fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI)] 100 µg/62.5 µg/25 µg with twice-daily inhaled corticosteroid/long-acting β-agonist therapy [budesonide/formoterol (BUD/FOR)] 400 µg/12 µg in patients with symptomatic COPD at risk of exacerbations. A subset participated for 52 weeks. Patient-reported assessments were: Evaluating Respiratory Symptoms in COPD™ (E-RS: COPD), St George's Respiratory Questionnaire (SGRQ) for COPD, COPD Assessment Test (CAT), baseline and transitional dyspnea indices (TDI) and daily and global anchor questions for activity limitation.
RESULTS
FF/UMEC/VI showed greater reductions from baseline in 4-weekly mean E-RS: COPD total and all subscale scores compared with BUD/FOR; differences were statistically significant (P < 0.05) at each time period. FF/UMEC/VI also demonstrated greater improvements from baseline at weeks 4 and 24 in SGRQ domain scores and TDI focal score compared with BUD/FOR. At weeks 4 and 24, improvements greater than the minimal clinically important difference from baseline were observed in CAT score with FF/UMEC/VI, but not BUD/FOR; differences were statistically significant (P ≤ 0.003).
CONCLUSION
These findings demonstrate sustained daily symptom and HRQoL benefits of FF/UMEC/VI versus BUD/FOR. The inclusion of the CAT may provide data that are readily generalizable to everyday clinical practice.
TRIAL REGISTRATION
ClinicalTrials.gov number: NCT02345161.
FUNDING
GSK.
介绍
直接记录患者的症状和健康相关生活质量（HRQoL）体验，可以补充慢性阻塞性肺疾病（COPD）临床研究中的肺功能和加重率数据。FULFIL 研究记录了日常症状和活动受限情况，以及呼吸困难和 HRQoL 等额外的患者报告结局，这是预先规定的分析内容之一。FULFIL 的主要次要终点数据此前已报告过。
方法
FULFIL 是一项为期 24 周、随机、双盲、双模拟、多中心的 III 期研究，比较了每日一次的三联单吸入疗法[糠酸氟替卡松/乌美溴铵/维兰特罗（FF/UMEC/VI）]100μg/62.5μg/25μg 与每日两次的吸入皮质激素/长效β激动剂疗法[布地奈德/福莫特罗（BUD/FOR）]400μg/12μg，用于有加重风险的症状性 COPD 患者。一部分患者参加了 52 周的研究。患者报告的评估包括：COPD 患者呼吸症状评估工具（E-RS：COPD）、COPD 圣乔治呼吸问卷（SGRQ）、COPD 评估测试（CAT）、基线和过渡性呼吸困难指数（TDI）以及日常和全球活动受限锚定问题。
结果
与 BUD/FOR 相比，FF/UMEC/VI 从基线到第 4 周的 4 周平均 E-RS：COPD 总分和所有子量表评分均有更大的降低；在每个时间段，差异均具有统计学意义（P < 0.05）。与 BUD/FOR 相比，FF/UMEC/VI 在第 4 周和第 24 周时，SGRQ 域评分和 TDI 焦点评分也有更大的改善。在第 4 周和第 24 周时，与 BUD/FOR 相比，CAT 评分的改善超过了从基线开始的最小临床重要差异，这在 FF/UMEC/VI 中是观察到的，但在 BUD/FOR 中没有观察到；差异具有统计学意义（P ≤ 0.003）。
结论
这些发现表明，与 BUD/FOR 相比，FF/UMEC/VI 持续改善了日常症状和 HRQoL。CAT 的纳入可能提供更易于推广到日常临床实践的数据。
试验注册
ClinicalTrials.gov 编号：NCT02345161。
资金来源
GSK。
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