The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China
单位：[1]Department of Pulmonary and Critical Care Medicine, Beijing Hospital, China. Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China. National Clinical Research Center for Respiratory Diseases, Beijing, China. Department of Respiratory Medicine, Capital Medical University, Beijing, China. Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[2]Department of Pulmonary and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, China. Beijing Institute of Respiratory Medicine, China北京朝阳医院[3]Department of Pulmonary and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. Beijing Institute of Respiratory Medicine, China北京朝阳医院[4]Department of Pulmonary and Critical Care Medicine, Beijing Hospital, Ministry of Health, Dongdan, China[5]The First Hospital of China Medical University, Heping, Shenyang, China[6]The First Affiliated Hospital of Guangzhou Medical University, Yuexiu, China[7]Henan Provincial People’s Hospital, Zhengzhou, China[8]Jilin University First Hospital, Changchun, China[9]Hebei United University Affiliated Hospital, Tangshan, China[10]Global Medicines Development, AstraZeneca, Shanghai, China[11]Biometrics, AstraZeneca, Osaka, Japan
Background: Patients diagnosed with chronic obstructive pulmonary disease (COPD) in China are commonly prescribed ipratropium plus theophylline (I+T) therapy. Studies have shown that an inhaled corticosteroid (ICS)/long-acting beta(2)-agonist (LABA) combination is also efficacious in reducing symptoms and exacerbations. This study evaluated the efficacy and tolerability of adding budesonide/formoterol (BUD/FORM) to I+T in Chinese patients with severe COPD. Methods: A randomized, parallel-group, open-label, multicenter phase IV study (Clinical Trials.gov identifier: NCT01415518) was conducted in China. Patients received either BUD/FORM (160/4.5 mu g; two inhalations twice daily [bid] via Turbuhaler (R)) + I (20 mu g per inhalation, two inhalations four times daily) + T (100 mg bid) or I+T alone for 12 weeks. The primary efficacy variable was change from baseline in predose forced expiratory volume in 1 s (FEV1). Results: A total of 584 patients were randomized equally between treatment groups. At the end of the study, the BUD/FORM plus I+T group displayed significant improvements in predose FEV1 versus the I+T group (between-group difference 6.9%; 95% confidence interval [CI]: 4.3, 9.6; p < 0.0001). Forced vital capacity, inspiratory capacity, peak expiratory flow and health-related quality of life (HRQoL) scores were significantly improved (all p < 0.0001) and exacerbation frequency was reduced (43.5% reduction; rate ratio 0.565, 95% CI 0.325, 0.981; p = 0.0425) with BUD/FORM plus I+T versus I+T alone. Conclusion: Patients with severe COPD in China treated with BUD/FORM plus I+T showed significant improvements in lung function and HRQoL and a reduction in exacerbations compared with I+T alone. Both treatments were well tolerated and no safety concerns were noted. The reviews of this paper are available via the supplemental material section.
基金：
AstraZenecaAstraZeneca; Research Special Fund for Public Welfare of Health from Ministry of Health of the People's Republic of China [201002008]
第一作者单位：[2]Department of Pulmonary and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, China. Beijing Institute of Respiratory Medicine, China
通讯作者：
通讯机构：[1]Department of Pulmonary and Critical Care Medicine, Beijing Hospital, China. Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China. National Clinical Research Center for Respiratory Diseases, Beijing, China. Department of Respiratory Medicine, Capital Medical University, Beijing, China. Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[*1]Department of Pulmonary and Critical Care Medicine, Beijing Hospital, Ministry of Health, No.1 Dahua Avenue, Dongdan, Beijing 100730, China
推荐引用方式(GB/T 7714)：
Huang Kewu,Guo Yanfei,Kang Jian,et al.The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China[J].THERAPEUTIC ADVANCES in RESPIRATORY DISEASE.2019,13:doi:10.1177/1753466619853500.
APA：
Huang, Kewu,Guo, Yanfei,Kang, Jian,An, Li,Zheng, Zeguang...&Wang, Chen.(2019).The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China.THERAPEUTIC ADVANCES in RESPIRATORY DISEASE,13,
MLA：
Huang, Kewu,et al."The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China".THERAPEUTIC ADVANCES in RESPIRATORY DISEASE 13.(2019)
