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首页> 外文期刊>International Journal of Chronic Obstructive Pulmonary Disease >Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a randomized Phase III study conducted in Asia, Europe, and the USA
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Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a randomized Phase III study conducted in Asia, Europe, and the USA

机译：在COPD中采用共同悬浮输送技术改善了肺功能并向患者报告了结果，其中所述的COPD吸入剂是复方格隆溴铵/福莫特罗富马酸盐计量吸入器：一项在亚洲，欧洲和美国进行的随机III期研究

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Background: COPD is a major global cause of mortality and morbidity. PINNACLE-4 evaluated the efficacy and safety of GFF MDI (glycopyrrolate/formoterol fumarate metered dose inhaler) in patients from Asia, Europe, and the USA with moderate-to-very severe COPD. Methods: In this double-blind, placebo-controlled, Phase III study, patients were randomized to treatment with GFF MDI 18/9.6?μg, glycopyrrolate (GP) MDI 18?μg, formoterol fumarate (FF) MDI 9.6?μg, or placebo MDI (all twice daily) for 24?weeks. Lung function, patient-reported outcomes (symptoms and health-related quality of life), and safety were assessed. Results: Of the 1,756 patients randomized, 1,740 patients were included in the intent-to-treat population (mean age 64.2?years, 74.1% male, and 40.2% Asian). GFF MDI significantly improved morning predose trough FEV1 at Week 24 (primary endpoint) vs placebo MDI, GP MDI, and FF MDI (least squares mean differences: 165, 59, and 72?mL, respectively; all P 0.0001). GFF MDI also significantly improved other lung function endpoints vs placebo MDI, GP MDI, and FF MDI and patient-reported outcomes vs placebo MDI and GP MDI. A larger proportion of patients treated with GFF MDI achieved the minimum clinically important difference in Transition Dyspnea Index score vs GP MDI and placebo MDI and in St George’s Respiratory Questionnaire score vs placebo MDI. Adverse event rates were similar across treatment groups. Conclusion: These results demonstrated the efficacy of GFF MDI in patients with moderate-to-very severe COPD. GFF MDI was well tolerated, with a safety profile commensurate with long-acting bronchodilators.
机译：背景：COPD是全球死亡率和发病率的主要原因。 PINNACLE-4评价了亚洲，欧洲和美国患有中度至非常重度COPD的患者中GFF MDI（吡咯烷酸盐/福莫特罗富马酸盐剂量吸入器）的疗效和安全性。方法：在这项双盲，安慰剂对照的III期研究中，患者被随机分配接受GFF MDI 18 / 9.6？g，格隆溴铵（GP）MDI 18？μg，富马酸福莫特罗（FF）MDI 9.6？μg或安慰剂MDI（每天两次）每天24周。评估了肺功能，患者报告的结局（症状和与健康相关的生活质量）和安全性。结果：在随机分派的1756名患者中，有1740名患者被纳入意向性治疗人群（平均年龄64.2岁，男性74.1％，亚洲40.2％）。与安慰剂MDI，GP MDI和FF MDI相比，GFF MDI在第24周（主要终点）的早剂量谷FEV1有了显着改善（最小二乘均方差分别为165、59和72？mL;所有P <0.0001）。与安慰剂MDI，GP MDI和FF MDI相比，GFF MDI还显着改善了其他肺功能终点，与安慰剂MDI和GP MDI相比，患者报告的结局也有所改善。接受GFF MDI治疗的患者中，较大比例的患者在过渡呼吸困难指数得分，GP MDI和安慰剂MDI以及圣乔治呼吸问卷调查得分和安慰剂MDI方面均达到了最小的临床重要差异。各治疗组的不良事件发生率相似。结论：这些结果证明了GFF MDI在中度至非常重度COPD患者中的疗效。 GFF MDI具有良好的耐受性，其安全性与长效支气管扩张剂相当。

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