■在随机对照试验中,含有二丙酸倍氯米松/富马酸福莫特罗/格隆溴铵87/5/9μg的体外单吸入器三联疗法(efSITT)已证明对慢性阻塞性肺疾病(COPD)患者有效。
■TRIWIN研究评估了efSITT在以前接受过多次吸入三联疗法(MITT)治疗的COPD患者中递送二丙酸倍氯米松/富马酸福莫特罗/格隆溴铵87/5/9μg的有效性。希腊的一项现实研究。
■预期,多中心,观察,非干预性研究进行了24周.
■总共475名符合条件的患者患有中度至重度COPD,使用efSITT治疗的适应症,尽管接受了MITT,但仍有症状。COPD评估测试(CAT)评分,肺功能参数,使用救援药物,并在基线(第1次访视)记录吸入器使用的依从性,3(访问2)治疗后6个月(访视3)。
■平均CAT得分从第1次访问时的21.4分下降到第2次访问时的16.6分和第3次访问时的15.1分(所有配对比较的p<0.001)。在第3次访问时,79.8%的患者达到了超过最小临床重要差异的CAT改善(2),与基线相比。1s内平均用力呼气量(%pred。)从第1次访问时的55.4%增加到研究期结束时的63.5%(p<0.001),而意味着强迫肺活量(%pred。)从第1次访问时的71.1%增加到第3次访问时的76.7%(p<0.001)。坚持吸入器的平均测试分数从42.5分增加到45.3分和46.3分,对于三次访问,分别(比较访问1/2和访问1/3,p<0.001;比较访问2/3,p=0.006)。显示良好依从性的患者百分比从基线时的33.7%上升到第3次访问时的58.3%。在研究期间结束时,使用救护药物的患者百分比从16.2%下降到7.4%(p<0.001)。肺功能参数也得到改善。
■TRIWIN结果表明,二丙酸倍氯米松/富马酸福莫特罗/格隆铵可以有效改善健康状况,肺功能,和依从性,并减少以前接受MITT治疗的COPD患者的抢救药物使用,在希腊的现实世界中。
UNASSIGNED: The extrafine single inhaler triple therapy (efSITT) containing beclomethasone dipropionate/formoterol fumarate/glycopyrronium 87/5/9 μg has proved to be efficacious in patients with chronic obstructive pulmonary disease (COPD) in randomized control trials.
UNASSIGNED: TRIWIN
study evaluated the effectiveness of efSITT delivering beclomethasone dipropionate/formoterol fumarate/glycopyrronium 87/5/9 μg in COPD patients previously treated with multiple-inhaler triple therapy (MITT) in a real-world
study in Greece.
UNASSIGNED: Prospective, multicenter, observational, non-interventional
study was conducted over 24 weeks.
UNASSIGNED: A total of 475 eligible patients had moderate-to-severe COPD, an indication for treatment with efSITT, and were symptomatic despite receiving MITT. COPD Assessment Test (CAT) score, pulmonary function parameters, use of rescue medication, and adherence to inhaler use were recorded at baseline (Visit 1), 3 (Visit 2), and 6 months (Visit 3) after treatment.
UNASSIGNED: Mean CAT score decreased from 21.4 points at Visit 1, to 16.6 at Visit 2 and 15.1 at Visit 3 (p < 0.001 for all pair comparisons). At Visit 3, 79.8% of patients reached a CAT improvement exceeding minimal clinically important difference (⩾2), compared to baseline. Mean forced expiratory volume in 1 s (%pred.) increased from 55.4% at Visit 1 to 63.5% at the end of
study period (p < 0.001), while mean forced vital capacity (%pred.) increased from 71.1% at Visit 1, to 76.7% at Visit 3 (p < 0.001). The mean Test of Adherence to Inhalers score increased from 42.5 to 45.3 and 46.3 points, for the three visits, respectively (p < 0.001 comparing Visits 1/2 and Visits 1/3; p = 0.006 comparing Visits 2/3). The percentage of patients showing good adherence rose from 33.7% at baseline to 58.3% at Visit 3. The percentage of patients using rescue medication during the last month dropped from 16.2% to 7.4% at the end of
study period (p < 0.001). Pulmonary function parameters also improved.
UNASSIGNED: The TRIWIN results suggest that extrafine beclomethasone dipropionate/formoterol fumarate/glycopyrronium is effective in improving health status, pulmonary function, and adherence and in reducing rescue medication use in COPD patients previously treated with MITT, in a real-world setting in Greece.