机构:[1]Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China[2]Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China[3]Department of Pulmonary Diseases, the First Hospital of China Medical University, Shenyang, China[4]Department of Pulmonary Diseases, Xinqiao Hospital, Chongqing, China[5]Department of Pulmonary Diseases, the Second Xiangya Hospital of Central South University, Changsha, China[6]Department of Pulmonary Diseases, Zhongshan Hospital, Fudan University, Shanghai, China[7]Department of Pulmonary Diseases, Capital Medical University Affiliated Beijing Friendship Hospital, Beijing, China首都医科大学附属北京友谊医院[8]Department of Pulmonary and Critical Care Medicine, Capital Medical University Affiliated Anzhen Hospital, Capital Medical University, Beijing, China临床科室呼吸内科首都医科大学附属安贞医院[9]Department of Pulmonary Diseases, First Affiliated Hospital of Kunming Medical University, Kunming, China昆明医科大学附属第一医院[10]Department of Pulmonary Diseases, Nanjing Chest Hospital, Nanjing, China[11]Boehringer Ingelheim, Shanghai, China
Purpose: Asthma affects approximately 30 million patients in China; however, tiotropium data for Chinese patients is limited. This study aimed to assess the efficacy and safety of tiotropium in Chinese patients with moderate symptomatic asthma. Methods: A post hoc subgroup analysis was conducted on 430 Chinese patients pooled from two 24-week, replicate phase 3 trials (NCT01172808 and NCT01172821), in which they received once-daily tiotropium 2.5 mu g (Tio R2.5) or 5 mu g (Tio R5) (n = 106 or 109, respectively), twice-daily salmeterol 50 mu g (Sal 50) (n = 110), or placebo (n = 105), while maintaining inhaled corticosteroids (ICS). The co-primary endpoints assessed in week 24 were forced expiratory volume in 1 second (FEV1) peak(0-3h), response, trough FEV1 response, and responder rate as assessed using the Asthma Control Questionnaire (ACQ). Results: For both FEV1 peak(0-)(3h) responses and trough FEV1 responses, the mean treatment differences were greater for Tio R2.5, no R5, and Sal 50 compared with placebo at 0.249 L, 0.234 L, and 0.284 L, and 0.172 L, 0.180 L, and 0.164 L, respectively (P< 0.001). The ACQ responder rate in placebo, Tio R2.5, Tio R5, and Sal 50 was 58.7%, 62.3%, 59.3%, and 69.1%, respectively. Furthermore, 11 (2.6%) of 430 patients had serious adverse events (Tio R5, n = 4; Tio R2.5, n = 1; Sal 50, n = 1; and placebo, n = 5). Conclusions: Once-daily tiotropium, as add-on to medium-dose ICS, was effective and well tolerated for Chinese patients with moderate symptomatic asthma, consistent with the main analysis.
第一作者机构:[1]Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China[*1]Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing 100029, China.
通讯作者:
通讯机构:[*1]Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing 100029, China.
推荐引用方式(GB/T 7714):
Lin Jiangtao,Wan Huanying,Kang Jian,et al.Add-on Tiotropium in Chinese Patients With Moderate Asthma: A Pooled Subgroup Analysis of MezzoTinA-Asthma 1 and 2[J].ALLERGY ASTHMA & IMMUNOLOGY RESEARCH.2019,11(4):519-528.doi:10.4168/aair.2019.11.4.519.
APA:
Lin, Jiangtao,Wan, Huanying,Kang, Jian,Ma, Qianli,Chen, Ping...&Hu, Na.(2019).Add-on Tiotropium in Chinese Patients With Moderate Asthma: A Pooled Subgroup Analysis of MezzoTinA-Asthma 1 and 2.ALLERGY ASTHMA & IMMUNOLOGY RESEARCH,11,(4)
MLA:
Lin, Jiangtao,et al."Add-on Tiotropium in Chinese Patients With Moderate Asthma: A Pooled Subgroup Analysis of MezzoTinA-Asthma 1 and 2".ALLERGY ASTHMA & IMMUNOLOGY RESEARCH 11..4(2019):519-528