Beeh Kai Michael, Kirsten Anne-Marie, Tanase Ana-Maria, Richard Alexia, Cao Weihua, Hederer Bettina, Beier Jutta, Kornmann Oliver, van Zyl-Smit Richard N
Insaf Respiratory Research Institute Wiesbaden, Wiesbaden, Germany,
Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.
Int J Chron Obstruct Pulmon Dis. 2018 Dec 6;13:3923-3936. doi: 10.2147/COPD.S179293. eCollection 2018.
Fixed-dose combinations of a long-acting beta agonist and an inhaled corticosteroid are more effective than the individual components in COPD. The primary study objective was to demonstrate that the combination indacaterol acetate/mometasone furoate (IND/MF [QMF149]) was non-inferior to the twice-daily combination salmeterol xinafoate/fluticasone propionate (Sal/Flu) in terms of trough FEV at week 12 (day 85). Secondary objectives were to compare the efficacy of IND/MF (QMF149) vs Sal/Flu with respect to other lung function parameters, COPD exacerbations, symptoms and dyspnea, health status/health-related quality of life, and rescue medication use.
This was a 12-week multicenter, randomized, double-blind, double-dummy, parallel-group, Phase II study in patients with moderate-to-very-severe COPD, who were randomized (1:1) to IND/MF (QMF149) (150/160 µg once daily; n=316) or Sal/Flu (50/500 µg twice daily; n=313).
Over 90% of patients completed the study: 94.6% in the IND/MF (QMF149) group and 92.0% in the Sal/Flu group. The primary objective of non-inferiority of IND/MF (QMF149) to Sal/Flu for trough FEV at week 12 (day 85) was met: the lower limit of the CI (95% CI: 27.7, 83.3 mL) was greater than -60 mL. The analysis for superiority of IND/MF (QMF149) to Sal/Flu demonstrated superiority of IND/MF (QMF149), with a difference of 56 mL (<0.001). In addition, IND/MF (QMF149) treatment significantly improved COPD exacerbation-related parameters during the 12-week period. Other significant improvements with IND/MF (QMF 149) vs Sal/Flu were noted for dyspnea at week 12 and other COPD symptoms and COPD rescue medication use over the 12 weeks. The safety and tolerability profiles of both the treatments were similar.
IND/MF (QMF149) (150/160 µg once daily) offered superior lung function and symptom efficacy and a favorable safety profile compared with Sal/Flu (50/500 µg twice daily) in patients with moderate-to-very severe COPD.
长效β受体激动剂与吸入性糖皮质激素的固定剂量组合在慢性阻塞性肺疾病（COPD）治疗中比单一成分更有效。主要研究目的是证明在第12周（第85天）的低谷第一秒用力呼气容积（FEV）方面，醋酸茚达特罗/糠酸莫米松组合（IND/MF [QMF149]）不劣于每日两次的沙美特罗辛纳福/丙酸氟替卡松组合（Sal/Flu）。次要目的是比较IND/MF（QMF149）与Sal/Flu在其他肺功能参数、COPD急性加重、症状与呼吸困难、健康状况/与健康相关的生活质量以及急救药物使用方面的疗效。
这是一项为期12周的多中心、随机、双盲、双模拟、平行组II期研究，纳入中度至极重度COPD患者，随机（1:1）分为IND/MF（QMF149）组（每日一次150/160μg；n = 316）或Sal/Flu组（每日两次50/500μg；n = 313）。
超过90%的患者完成了研究：IND/MF（QMF149）组为94.6%，Sal/Flu组为92.0%。IND/MF（QMF149）在第12周（第85天）低谷FEV方面不劣于Sal/Flu这一主要目标达成：置信区间（CI）下限（95%CI：27.7，83.3mL）大于 - 60mL。IND/MF（QMF149）优于Sal/Flu的分析显示IND/MF（QMF149）具有优越性，差值为56mL（<0.001）。此外，IND/MF（QMF149）治疗在12周期间显著改善了与COPD急性加重相关的参数。在第12周的呼吸困难以及12周内的其他COPD症状和COPD急救药物使用方面，IND/MF（QMF149）与Sal/Flu相比也有其他显著改善。两种治疗的安全性和耐受性概况相似。
在中度至极重度COPD患者中，与每日两次50/500μg的Sal/Flu相比，每日一次150/160μg的IND/MF（QMF149）具有更优的肺功能和症状疗效以及良好的安全性。
