Roflumilast for the treatment of COPD in an Asian population: A randomized, double-blind, parallel-group study

Chest

Volumn 145, Issue 1, 2014, Pages 44-52

  Zheng, Jinping ^a   Yang, Jinghua ^b   Zhou, Xiangdong ^c   Zhao, Li ^d   Hui, Fuxin ^e   Wang, Haoyan ^f   Bai, Chunxue ^g   Chen, Ping ^h   Li, Huiping ⁱ   Kang, Jian ^d   Brose, Manja ^j   Richard, Frank ^j   Goehring, Udo Michael ^j   Zhong, Nanshan ^a  

^a GUANGZHOU MEDICAL UNIVERSITY   (China)

^b CAPITAL MEDICAL UNIVERSITY   (China)

^c THIRD MILITARY MEDICAL UNIVERSITY   (China)

^d CHINA MEDICAL UNIVERSITY   (China)

^e WUXI PEOPLE S HOSPITAL AFFILIATED TO NANJING MEDICAL UNIVERSITY   (China)

^f CAPITAL MEDICAL UNIVERSITY   (China)

^g ZHONGSHAN HOSPITAL OF FUDAN UNIVERSITY   (China)

^h GENERAL HOSPITAL OF NORTHERN THEATER COMMAND   (China)

ⁱ TONGJI UNIVERSITY SCHOOL OF MEDICINE   (China)

^j Takeda Pharmaceuticals International GmbH   (Switzerland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; ROFLUMILAST;

ADULT; ARTICLE; BRONCHODILATING ACTIVITY; CHINESE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; ETHNIC GROUP; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HUMAN; HUMAN CELL; INDIAN; MALAY; MALE; MIDDLE AGED; MORNING DOSAGE; POPULATION RESEARCH; PRIORITY JOURNAL; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT; WEIGHT GAIN;

AGED; AMINOPYRIDINES; ASIAN CONTINENTAL ANCESTRY GROUP; BENZAMIDES; CYCLOPROPANES; DOUBLE-BLIND METHOD; EUROPEAN CONTINENTAL ANCESTRY GROUP; FEMALE; FORCED EXPIRATORY VOLUME; HUMANS; MALE; MIDDLE AGED; PHOSPHODIESTERASE 4 INHIBITORS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84892664131     PISSN: 00123692     EISSN: 19313543     Source Type: Journal    
DOI: 10.1378/chest.13-1252     Document Type: Article

References (24)

1. World Health Organization. Global Burden of Disease 2004 Update. 2008. WHO website. http://www.who.int. Accessed September 2, 2013.
2. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006; 3(11): e442.
3. Zhong N, Wang C, Yao W, et al. Prevalence of chronic obstructive pulmonary disease in China: a large, population-based survey. Am J Respir Crit Care Med. 2007; 176 (8): 753-760.
4. Sandelowsky H, Ställberg B, Nager A, Hasselström J. The prevalence of undiagnosed chronic obstructive pulmonary dis ease in a primary care population with respiratory tract infections - a case finding study. BMC Fam Pract. 2011; 12: 122.
5. Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future trends. Lancet. 2007; 370 (9589): 765-773.
6. Boschetto P, Quintavalle S, Miotto D, Lo Cascio N, Zeni E, Mapp CE. Chronic obstructive pulmonary disease (COPD) and occupational exposures. J Occup Med Toxicol. 2006; 1: 11.
7. Hu G, Zhou Y, Tian J, et al. Risk of COPD from exposure to biomass smoke: a metaanalysis. Chest. 2010; 138 (1): 20-31.
8. Salvi SS, Barnes PJ. Chronic obstructive pulmonary disease in non-smokers. Lancet. 2009; 374 (9691): 733-743.
9. The Global Initiative for Chronic Obstructive Lung Dis ease (GOLD) global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. GOLD website. http://www.goldcopd.org. Revised 2011. Accessed September 2, 2013.
10. Zheng JP, Kang J, Huang SG, et al. Effect of carbocisteine on acute exacerbation of chronic obstructive pulmonary disease (PEACE study): a randomised placebo-controlled study. Lancet. 2008; 371 (9629): 2013-2018.
11. Zhou Y, Wang X, Zeng X, et al. Positive benefits of theophylline in a randomized, double-blind, parallel-group, placebocontrolled study of low-dose, slow-release theophylline in the treatment of COPD for 1 year. Respirology. 2006; 11 (5): 603-610.
12. Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflu milast in symptomatic chronic obstructive pulmonary dis ease: two randomised clinical trials. Lancet. 2009; 374 (9691): 685-694.
13. Chong J, Poole P, Leung B, Black PN. Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2011; (5): CD002309.
14. Fabbri LM, Calverley PM, Izquierdo-Alonso JL, et al; M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet. 2009; 374 (9691): 695-703.
15. Lee SD, Hui DS, Mahayiddin AA, et al. Roflumilast in Asian patients with COPD: a randomized placebo-controlled trial. Respirology. 2011; 16 (8): 1249-1257.
16. Rabe KF, Bateman ED, O'Donnell D, Witte S, Bredenbröker D, Bethke TD. Roflumilast - an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 2005; 366 (9485): 563-571.
17. Zhong NS. Management of Asthma in Developing Counties. Asthma. Philadelphia, PA: Lippincott-Raven; 1997: 1869- 1881.
18. Chow SC. Encyclopedia of Biopharmaceutical Statistics-Revised and Expanded. 2nd ed. Basel, Switzerland: Marcel Dekker; 2009.
19. Zhang FQ, Zheng JP, Wang JH, et al. Comparison of lung volume response with airflow response to bronchodilator in patients with chronic obstructive pulmonary disease [in Chinese]. Zhonghua Jie He He Hu Xi Za Zhi. 2010; 33 (2): 109-113.
20. Tashkin DP, Celli B, Decramer M, et al. Bronchodilator responsiveness in patients with COPD. Eur Respir J. 2008; 31 (4): 742-750.
21. Zheng JP, Yang L, Wu YM, et al. The efficacy and safety of combination salmeterol (50 microg)/fluticasone propionate (500 microg) inhalation twice daily via accuhaler in Chinese patients with COPD. Chest. 2007; 132 (6): 1756-1763.
22. Zhong N, Zheng J, Wen F, et al. Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease. Curr Med Res Opin. 2012; 28 (2): 257-265.
23. Bateman ED, Rabe KF, Calverley PM, et al. Roflumilast with long-acting b 2-agonists for COPD: influence of exacerbation history. Eur Respir J. 2011; 38 (3): 553-560.
24. Rennard SI, Calverley PM, Goehring UM, Bredenbröker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast - the importance of defining different subsets of patients with COPD. Respir Res. 2011; 12: 18.