Jinping Zheng1, Jinghua Yang2, Xiangdong Zhou3, Li Zhao4, Fuxin Hui5, Haoyan Wang6, Chunxue Bai7, Ping Chen8, Huiping Li9, Jian Kang10, Manja Brose11, Frank Richard12, Udo-Michael Goehring12, Nanshan Zhong13. 1. State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Disease, 1st Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. 2. Beijing Anzhen Hospital affiliated to Capital Medical University, Beijing, China. 3. Southwest Hospital (First Affiliated Hospital of Third Military Medical University of PLA), Chongqing, China. 4. Shengjing Hospital of China Medical University, Shenyang, Liaoning, China. 5. Wuxi People's Hospital, Wuxi, Jiangsu, China. 6. Beijing Friendship Hospital affiliated to Capital Medical University, Beijing, China. 7. Zhongshan Hospital Fudan University and Shanghai Respiratory Research Institute, Shanghai, China. 8. The General Hospital of Shenyang Military Region of PLA, Shenyang, Liaoning Province, China. 9. School of Medicine, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China. 10. The First Hospital of China Medical University, Shenyang, Liaoning, China. 11. Analytical Science, Takeda Pharmaceuticals International GmbH, Zurich, Switzerland. 12. Clinical Science, Takeda Pharmaceuticals International GmbH, Zurich, Switzerland. 13. 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.
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.
RCT Entities:
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.