title: Roflumilast for the treatment of COPD in an Asian population: a randomized, double-blind, parallel-group study.
abstract: BACKGROUND
  Roflumilast is the only oral phosphodiesterase 4 inhibitor indicated for use in the treatment of COPD. Previous studies of roflumilast have predominantly involved European and North American populations. A large study was necessary to determine the efficacy and safety of roflumilast in a predominantly ethnic Chinese population.
  
  
  METHODS
  In a placebo-controlled, double-blind, parallel-group, multicenter, phase 3 study, patients of Chinese, Malay, and Indian ethnicity (N = 626) with severe to very severe COPD were randomized 1:1 to receive either roflumilast 500 μg once daily or placebo for 24 weeks. The primary end point was change in prebronchodilator FEV1 from baseline to study end.
  
  
  RESULTS
  Three hundred thirteen patients were assigned to each treatment. Roflumilast provided a sustained increase over placebo in mean prebronchodilator FEV1 (0.071 L; 95% CI, 0.046, 0.095 L; P < .0001). Similar improvements were observed in the secondary end points of postbronchodilator FEV1 (0.068 L; 95% CI 0.044, 0.092 L; P < .0001) and prebronchodilator and postbronchodilator FVC (0.109 L; 95% CI, 0.061, 0.157 L; P < .0001 and 0.101 L; 95% CI, 0.055, 0.146 L; P < .0001, respectively). The adverse event profile was consistent with previous roflumilast studies. The most frequently reported treatment-related adverse event was diarrhea (6.0% and 1.0% of patients in the roflumilast and placebo groups, respectively).
  
  
  CONCLUSIONS
  Roflumilast plays an important role in lung function improvement and is well tolerated in an Asian population. It provides an optimal treatment choice for patients with severe to very severe COPD.
authors.affiliation: State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Disease, 1st Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
authors.forename: Jinping
authors.initials: J
authors.lastname: Zheng
authors.affiliation: Beijing Anzhen Hospital affiliated to Capital Medical University, Beijing, China.
authors.forename: Jinghua
authors.initials: J
authors.lastname: Yang
authors.affiliation: Southwest Hospital (First Affiliated Hospital of Third Military Medical University of PLA), Chongqing, China.
authors.forename: Xiangdong
authors.initials: X
authors.lastname: Zhou
authors.affiliation: Shengjing Hospital of China Medical University, Shenyang, Liaoning, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zhao
authors.affiliation: Wuxi People's Hospital, Wuxi, Jiangsu, China.
authors.forename: Fuxin
authors.initials: F
authors.lastname: Hui
authors.affiliation: Beijing Friendship Hospital affiliated to Capital Medical University, Beijing, China.
authors.forename: Haoyan
authors.initials: H
authors.lastname: Wang
authors.affiliation: Zhongshan Hospital Fudan University and Shanghai Respiratory Research Institute, Shanghai, China.
authors.forename: Chunxue
authors.initials: C
authors.lastname: Bai
authors.affiliation: The General Hospital of Shenyang Military Region of PLA, Shenyang, Liaoning Province, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Chen
authors.affiliation: School of Medicine, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China.
authors.forename: Huiping
authors.initials: H
authors.lastname: Li
authors.affiliation: The First Hospital of China Medical University, Shenyang, Liaoning, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Kang
authors.affiliation: Analytical Science, Takeda Pharmaceuticals International GmbH, Zurich, Switzerland.
authors.forename: Manja
authors.initials: M
authors.lastname: Brose
authors.affiliation: Clinical Science, Takeda Pharmaceuticals International GmbH, Zurich, Switzerland.
authors.forename: Frank
authors.initials: F
authors.lastname: Richard
authors.affiliation: Clinical Science, Takeda Pharmaceuticals International GmbH, Zurich, Switzerland.
authors.forename: Udo-Michael
authors.initials: UM
authors.lastname: Goehring
authors.affiliation: State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Disease, 1st Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. Electronic address: nanshan@vip.163.com.
authors.forename: Nanshan
authors.initials: N
authors.lastname: Zhong
mesh_terms: D000368:Aged; D000631:Aminopyridines / Q000627:therapeutic use*; D044466:Asian People; D001549:Benzamides / Q000627:therapeutic use*; D003521:Cyclopropanes / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D058988:Phosphodiesterase 4 Inhibitors / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000208:ethnology; D012720:Severity of Illness Index; D016896:Treatment Outcome; D044465:White People
chemical_list: D000631:Aminopyridines; D001549:Benzamides; D003521:Cyclopropanes; D058988:Phosphodiesterase 4 Inhibitors; C424423:Roflumilast