Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD
单位：[1]Shenzhen Institute of Respiratory Diseases,Shenzhen People’s Hospital, Shenzhen,Guangdong, People’s Republic of China深圳市人民医院深圳医学信息中心[2]Guangzhou Institute of Respiratory Health,State Key Laboratory of RespiratoryDiseases, National Clinical Research Centrefor Respiratory Diseases, First AffiliatedHospital of Guangzhou Medical University,Guangzhou, People’s Republic of China[3]Beijing Friendship Hospital, Capital MedicalUniversity, Beijing, People’s Republic ofChina首都医科大学附属北京友谊医院[4]Sheng Jing Hospital of China MedicalUniversity, Shenyang, Liaoning, People’sRepublic of China中国医科大学附属盛京医院[5]Anhui ProvincialHospital, Hefei, Anhui, People’s Republic ofChina[6]The People’s Hospital of GuangxiZhuang Autonomous Region, Nanning City,Guangxi Zhuang Autonomous Region,People’s Republic of China[7]Formerly ofAstraZeneca, Shanghai, People’s Republic ofChina[8]AstraZeneca, Shanghai, People’sRepublic of China[9]AstraZeneca,Morristown, NJ, USA[10]AstraZeneca,Gaithersburg, MD, USA
Background: Glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) is a long-acting muscarinic antagonist/long-acting beta(2)-agonist fixed-dose combination therapy delivered by MDI, formulated using innovative co-suspension delivery technology. The PINNACLE-4 study evaluated the efficacy and safety of GFF MDI in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) from Asia, Europe, and the USA. This article presents the results from the China subpopulation of PINNACLE-4. Methods: In this randomized, double-blind, placebo-controlled, parallel-group Phase III study (NCT02343458), patients received GFF MDI 18/9.6 mu g, glycopyrrolate (GP) MDI 18 mu g, formoterol fumarate (FF) MDI 9.6 mu g, or placebo MDI (all twice daily) for 24 weeks. The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 second at Week 24. Secondary lung function endpoints and patient-reported outcome measures were also assessed. Safety was monitored throughout the study. Results: Overall, 466 patients from China were included in the intent-to-treat population (mean age 63.6 years, 95.7% male). Treatment with GFF MDI improved the primary endpoint compared to GP MDI, FF MDI, and placebo MDI (least squares mean differences: 98, 104, and 173 mL, respectively; all P <= 0.0001). GFF MDI also improved daily total symptom scores and time to first clinically important deterioration versus monocomponents and placebo MDI, and Transition Dyspnea Index focal score versus placebo MDI. Rates of treatment-emergent adverse events were similar across the active treatment groups and slightly higher in the placebo MDI group. Conclusion: GFF MDI improved lung function and daily symptoms versus monocomponents and placebo MDI and improved dyspnea versus placebo MDI. All treatments were well tolerated with no unexpected safety findings. Efficacy and safety results were generally consistent with the global PINNACLE-4 population, supporting the use of GFF MDI in patients with COPD from China.
第一作者单位：[1]Shenzhen Institute of Respiratory Diseases,Shenzhen People’s Hospital, Shenzhen,Guangdong, People’s Republic of China
通讯作者：
通讯机构：[2]Guangzhou Institute of Respiratory Health,State Key Laboratory of RespiratoryDiseases, National Clinical Research Centrefor Respiratory Diseases, First AffiliatedHospital of Guangzhou Medical University,Guangzhou, People’s Republic of China[*1]Guangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Diseases, National Clinical Research Centre for Respiratory Diseases, First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Road, Guangzhou 510120, Guangdong, People’s Republic of China
推荐引用方式(GB/T 7714)：
Chen Rongchang,Zhong Nanshan,Wang Hao-Yan,et al.Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD[J].INTERNATIONAL JOURNAL of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.2020,15:43-56.doi:10.2147/COPD.S223638.
APA：
Chen, Rongchang,Zhong, Nanshan,Wang, Hao-Yan,Zhao, Li,Mei, Xiaodong...&Reisner, Colin.(2020).Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD.INTERNATIONAL JOURNAL of CHRONIC OBSTRUCTIVE PULMONARY DISEASE,15,
MLA：
Chen, Rongchang,et al."Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD".INTERNATIONAL JOURNAL of CHRONIC OBSTRUCTIVE PULMONARY DISEASE 15.(2020):43-56
