单位：[1]Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China- Japan Friendship Hospital, No. 2, East Yinghua Street, Chaoyang District, Beijing 100029, China[2]Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China[3]National Clinical Research Center for Respiratory Diseases, Beijing, China[4]Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[5]Department of Respiratory Medicine, Capital Medical University, Beijing, China[6]The First Hospital of China Medical University, Shenyang, China[7]The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China[8]Shengjing Hospital of China Medical University, Shenyang, China中国医科大学附属盛京医院[9]The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China内蒙古科技大学包头医学院[10]AstraZeneca, Shanghai, China[11]AstraZeneca, Durham, NC, USA[12]AstraZeneca, Morristown, NJ, USA[13]Formerly of AstraZeneca, Durham, NC, USA
Introduction This pre-specified subgroup analysis evaluated the efficacy and safety of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) triple therapy versus corresponding dual therapies in the China subgroup of the phase III, double-blind KRONOS study in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Methods Patients were randomized 2:2:1:1 to BGF MDI 320/18/9.6 mu g, glycopyrrolate/formoterol fumarate (GFF) MDI 18/9.6 mu g, budesonide/formoterol fumarate (BFF) MDI 320/9.6 mu g, or budesonide/formoterol fumarate dry powder inhaler (BUD/FORM DPI) 400/12 mu g twice daily for 24 weeks. The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV1) over weeks 12-24. Secondary endpoints included symptoms, health-related quality of life, and safety. Rate of moderate/severe COPD exacerbations was an additional efficacy endpoint. Results In the China subgroup (n = 432; 22.7% of the KRONOS population), BGF MDI demonstrated nominally significant improvements in the primary endpoint versus BFF MDI (least squares mean (LSM) difference 68 mL; P = 0.0035) and BUD/FORM DPI (LSM difference 78 mL; P = 0.0010) but not GFF MDI (LSM difference - 4 mL; P = 0.8316). BGF MDI demonstrated at least numerical improvements versus comparators in secondary lung function and symptom endpoints. BGF MDI reduced the rate of moderate/severe COPD exacerbations versus GFF MDI (rate ratio 0.41; P = 0.0030), with numerical benefits versus BFF MDI and BUD/FORM DPI. All treatments were well tolerated. Conclusions Results demonstrated that BGF MDI showed benefits on lung function (vs inhaled corticosteroid/long-acting beta(2)-agonist), as well as symptoms and exacerbations relative to dual therapies. Findings support BGF MDI use in Chinese patients with moderate to very severe COPD.
基金：
AstraZenecaAstraZeneca
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2019]版：
大类|3 区医学
小类|3 区医学：研究与实验3 区药学
最新[2025]版：
大类|3 区医学
小类|2 区药学3 区医学：研究与实验
JCR分区：
出版当年[2018]版：
Q2MEDICINE, RESEARCH & EXPERIMENTALQ2PHARMACOLOGY & PHARMACY
最新[2023]版：
Q2MEDICINE, RESEARCH & EXPERIMENTALQ2PHARMACOLOGY & PHARMACY
第一作者单位：[1]Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China- Japan Friendship Hospital, No. 2, East Yinghua Street, Chaoyang District, Beijing 100029, China[2]Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China[3]National Clinical Research Center for Respiratory Diseases, Beijing, China[4]Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[5]Department of Respiratory Medicine, Capital Medical University, Beijing, China
通讯作者：
通讯机构：[1]Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China- Japan Friendship Hospital, No. 2, East Yinghua Street, Chaoyang District, Beijing 100029, China[2]Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China[3]National Clinical Research Center for Respiratory Diseases, Beijing, China[4]Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[5]Department of Respiratory Medicine, Capital Medical University, Beijing, China
推荐引用方式(GB/T 7714)：
Wang Chen,Yang Ting,Kang Jian,et al.Efficacy and Safety of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Chinese Patients with COPD: A Subgroup Analysis of KRONOS[J].ADVANCES in THERAPY.2020,37(4):1591-1607.doi:10.1007/s12325-020-01266-5.
APA：
Wang, Chen,Yang, Ting,Kang, Jian,Chen, Rongchang,Zhao, Li...&Dorinsky, Paul.(2020).Efficacy and Safety of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Chinese Patients with COPD: A Subgroup Analysis of KRONOS.ADVANCES in THERAPY,37,(4)
MLA：
Wang, Chen,et al."Efficacy and Safety of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Chinese Patients with COPD: A Subgroup Analysis of KRONOS".ADVANCES in THERAPY 37..4(2020):1591-1607
