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Original Research: COPD |

Roflumilast for the Treatment of COPD in an Asian PopulationRoflumilast in an Asian COPD Population: A Randomized, Double-Blind, Parallel-Group Study

Jinping Zheng, MD; Jinghua Yang, MSc; Xiangdong Zhou, MD; Li Zhao, PhD; Fuxin Hui, BSc; Haoyan Wang, MD; Chunxue Bai, MD, PhD, FCCP; Ping Chen, BSc; Huiping Li, PhD, FCCP; Jian Kang, MD, PhD, FCCP; Manja Brose, MSc; Frank Richard, MD; Udo-Michael Goehring, MD; Nanshan Zhong, MD
Author and Funding Information

From the State Key Laboratory of Respiratory Disease (Profs Zheng and Zhong), Guangzhou Institute of Respiratory Disease, 1st Affiliated Hospital of Guangzhou Medical University, Guangzhou, China; Beijing Anzhen Hospital affiliated to Capital Medical University (Prof Yang), Beijing, China; Southwest Hospital (First Affiliated Hospital of Third Military Medical University of PLA) (Prof Zhou), Chongqing, China; Shengjing Hospital of China Medical University (Prof Zhao), Shenyang, Liaoning, China; Wuxi People’s Hospital (Dr Hui), Wuxi, Jiangsu, China; Beijing Friendship Hospital affiliated to Capital Medical University (Prof Wang), Beijing, China; Zhongshan Hospital Fudan University and Shanghai Respiratory Research Institute (Prof Bai), Shanghai, China; The General Hospital of Shenyang Military Region of PLA (Prof Chen), Shenyang, Liaoning Province, China; School of Medicine (Prof Li), Shanghai Pulmonary Hospital, Tongji University, Shanghai, China; The First Hospital of China Medical University (Prof Kang), Shenyang, Liaoning, China; and Analytical Science (Ms Brose) and Clinical Science (Drs Richard and Goehring), Takeda Pharmaceuticals International GmbH, Zurich, Switzerland.

Correspondence to: Nanshan Zhong, MD, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Disease, 1st Affiliated Hospital of Guangzhou Medical University, No. 151 Yanjiang Rd, Guangzhou 510120, China; e-mail: nanshan@vip.163.com


Drs Zheng and Zhong contributed equally.

The protocol and preliminary results of this study were presented at the 17th Congress of the Asian Pacific Society of Respirology, December 15, 2012, Hong Kong, China.

Funding/Support: This study was supported by Takeda Pharmaceuticals International GmbH.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2014;145(1):44-52. doi:10.1378/chest.13-1252
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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.

Trial registry:  ClinicalTrials.gov; No.: NCT01313494; URL: www.clinicaltrials.gov.

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