Efficacy and Safety of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Chinese Patients with COPD: A Subgroup Analysis of KRONOS.

Autor: Wang C; 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. cyh-birm@263.net.; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China. cyh-birm@263.net.; National Clinical Research Center for Respiratory Diseases, Beijing, China. cyh-birm@263.net.; Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. cyh-birm@263.net.; Department of Respiratory Medicine, Capital Medical University, Beijing, China. cyh-birm@263.net., Yang T; 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.; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China.; National Clinical Research Center for Respiratory Diseases, Beijing, China.; Department of Respiratory Medicine, Capital Medical University, Beijing, China., Kang J; The First Hospital of China Medical University, Shenyang, China., Chen R; The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China., Zhao L; Shengjing Hospital of China Medical University, Shenyang, China., He H; The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China., Assam PN; AstraZeneca, Shanghai, China., Su R; AstraZeneca, Shanghai, China., Bourne E; AstraZeneca, Durham, NC, USA., Ballal S; AstraZeneca, Morristown, NJ, USA., DeAngelis K; Formerly of AstraZeneca, Durham, NC, USA., Dorinsky P; AstraZeneca, Durham, NC, USA.
Jazyk: angličtina
Zdroj: Advances in therapy [Adv Ther] 2020 Apr; Vol. 37 (4), pp. 1591-1607. Date of Electronic Publication: 2020 Mar 06.
DOI: 10.1007/s12325-020-01266-5
Abstrakt: 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 μg, glycopyrrolate/formoterol fumarate (GFF) MDI 18/9.6 μg, budesonide/formoterol fumarate (BFF) MDI 320/9.6 μg, or budesonide/formoterol fumarate dry powder inhaler (BUD/FORM DPI) 400/12 μg twice daily for 24 weeks. The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV 1 ) 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 β 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.
Clinical Trial Registration: ClinicalTrials.gov NCT02497001.
Databáze: MEDLINE
Externí odkaz: