Crisor LLC, Clinical Research Institute, 3860 Crater Lake Ave., Medford, OR 97504, USA.
GSK, Brentford, Middlesex, UK.
Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620926949. doi: 10.1177/1753466620926949.
In chronic obstructive pulmonary disease (COPD), both the time needed for patients to gain symptom improvement with long-acting bronchodilator therapy and whether an early response is predictive of a sustained response is unknown. This study aimed to investigate how quickly meaningful symptom responses are seen in patients with COPD with bronchodilator therapy and whether these responses are sustained.
Early MAXimisation of bronchodilation for improving COPD stability (EMAX) was a 24-week, double-blind, double-dummy, parallel-group trial that randomised patients to umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol. Daily Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score and rescue salbutamol use were captured an electronic diary and analysed initially in 4-weekly periods. analyses assessed change from baseline in daily E-RS:COPD score and rescue medication use weekly (Weeks 1-8), and association between E-RS:COPD responder status at Weeks 1-4 and later time points.
In the intent-to-treat population ( = 2425), reductions from baseline in E-RS:COPD scores and rescue medication use were apparent from Day 2 with all treatments. Treatment differences for UMEC/VI either monotherapy plateaued by Week 4-8 and were sustained at Weeks 21-24; improvements were consistently greater with UMEC/VI. For all treatments, most patients (60-85%) retained their Weeks 1-4 E-RS:COPD responder/non-responder status at Weeks 21-24. Among patients receiving UMEC/VI who were E-RS:COPD responders at Weeks 1-4, 70% were responders at Weeks 21-24.
Patients with symptomatic COPD had greater potential for early symptom improvements with UMEC/VI either monotherapy. This benefit was generally maintained for 24 weeks. Early monitoring of treatment response can provide clinicians with an early indication of a patient's likely longer-term response to prescribed bronchodilator treatment and will facilitate appropriate early adjustments in care.
NCT03034915, 2016-002513-22 (EudraCT Number).
在慢性阻塞性肺疾病（COPD）中，患者接受长效支气管扩张剂治疗后获得症状改善所需的时间以及早期反应是否可预测持续反应尚不清楚。本研究旨在探讨 COPD 患者接受支气管扩张剂治疗后何时能迅速看到有意义的症状缓解，以及这些缓解是否可持续。
早期最大程度改善 COPD 稳定性的支气管扩张（EMAX）是一项为期 24 周、双盲、双模拟、平行组试验，将患者随机分为乌美溴铵/维兰特罗（UMEC/VI）、乌美溴铵或沙美特罗组。每日评估 COPD 患者的呼吸系统症状（E-RS：COPD）评分和急救沙丁胺醇使用情况通过电子日记记录，并在最初的 4 周期间进行分析。分析评估了从基线开始每周（第 1-8 周）每日 E-RS：COPD 评分和急救药物使用的变化，以及第 1-4 周时 E-RS：COPD 应答者状态与后期时间点的关联。
在意向治疗人群（ = 2425）中，所有治疗组在第 2 天即开始出现 E-RS：COPD 评分和急救药物使用的降低。UMEC/VI 任一单药治疗的差异在第 4-8 周时达到平台期，并在第 21-24 周时保持稳定；UMEC/VI 的改善始终更大。对于所有治疗，大多数患者（60-85%）在第 21-24 周时保持了第 1-4 周的 E-RS：COPD 应答者/非应答者状态。在第 1-4 周时对 E-RS：COPD 有应答的接受 UMEC/VI 治疗的患者中，70%在第 21-24 周时仍有应答。
有症状的 COPD 患者接受 UMEC/VI 任一单药治疗时，早期症状改善的潜力更大。这种益处通常可持续 24 周。早期监测治疗反应可以为临床医生提供患者对处方支气管扩张剂治疗的可能长期反应的早期迹象，并有助于早期调整护理。
NCT03034915，2016-002513-22（EudraCT 编号）。
