Anti-inflammatory effects of salmeterol/fluticasone propionate 50/250 mcg combination therapy in japanese patients with chronic obstructive pulmonary disease

International Journal of COPD

Volumn 10, Issue , 2015, Pages 803-811

  Asai, Kazuhisa ^a   Kobayashi, Akihiro ^b   Makihara, Yukio ^b   Johnson, Malcolm ^c  

^a OSAKA CITY UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b Development and Medical Affairs Division   (Japan)

^c GLAXOSMITHKLINE   (United Kingdom)

Author keywords

Biomarkers; IL 8; Neutrophils; Serum; Sputum

Indexed keywords

BIOLOGICAL MARKER; C REACTIVE PROTEIN; FLUTICASONE PROPIONATE PLUS SALMETEROL; GAMMA INTERFERON; INTERLEUKIN 6; INTERLEUKIN 8; MYELOPEROXIDASE; PLACEBO; SURFACTANT PROTEIN D; ANTIINFLAMMATORY AGENT; AUTACOID; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; BRONCHODILATING AGENT; FLUTICASONE PROPIONATE PLUS SALMETEROL XINAFOATE; GLUCOCORTICOID;

ADULT; AGED; ANTIINFLAMMATORY ACTIVITY; ARTICLE; BLOOD ANALYSIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CHRONIC OBSTRUCTIVE LUNG DISEASE ASSESSMENT TEST; CLARA CELL; CLINICAL ARTICLE; CLINICAL ASSESSMENT TOOL; CONTROLLED STUDY; DIABETES MELLITUS; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DOWN REGULATION; DRUG EFFICACY; DRUG RESPONSE; DRY POWDER INHALER; DYSPHONIA; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HEALTH STATUS; HUMAN; INFLAMMATION; JAPANESE (PEOPLE); LUNG FUNCTION TEST; MALE; NEUTROPHIL COUNT; OROPHARYNX PAIN; OUTCOME ASSESSMENT; PHARYNGITIS; PROTEIN DETERMINATION; PROTEIN EXPRESSION; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SPUTUM ANALYSIS; SQUAMOUS EPITHELIUM CELL; STOMATITIS; THRUSH; UPREGULATION; VERY ELDERLY; ASIAN CONTINENTAL ANCESTRY GROUP; BLOOD; CYTOLOGY; DRUG EFFECTS; ETHNOLOGY; IMMUNOLOGY; JAPAN; LEUKOCYTE COUNT; LUNG; MIDDLE AGED; NEUTROPHIL; PATHOPHYSIOLOGY; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SPUTUM; TIME FACTOR; TREATMENT OUTCOME;

ADRENERGIC BETA-2 RECEPTOR AGONISTS; ADULT; AGED; AGED, 80 AND OVER; ANTI-INFLAMMATORY AGENTS; ASIAN CONTINENTAL ANCESTRY GROUP; BIOMARKERS; BRONCHODILATOR AGENTS; DOUBLE-BLIND METHOD; FEMALE; FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE DRUG COMBINATION; GLUCOCORTICOIDS; HEALTH STATUS; HUMANS; INFLAMMATION MEDIATORS; JAPAN; LEUKOCYTE COUNT; LUNG; MALE; MIDDLE AGED; NEUTROPHILS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SPUTUM; SURVEYS AND QUESTIONNAIRES; TIME FACTORS; TREATMENT OUTCOME;

EID: 84929401718     PISSN: 11769106     EISSN: 11782005     Source Type: Journal    
DOI: 10.2147/COPD.S79842     Document Type: Article

References (35)

1. Japanese Respiratory Society. [Japanese Respiratory Society COPD Guideline ver. 4]. Tokyo, Japan: Tokyo Incorporated Association, JRS; 2013. Japanese.
2. Betsuyaku T, Kato M, Fujimoto K, et al. A study to assess COPD Symptom-based Management and to Optimise treatment Strategy in Japan (COSMOS-J) based on GOLD 2011. Int J Chron Obstruct Pulmon Dis. 2013;8:453–459.
3. Ichinose M, Aizawa H, Ishizaka A, et al. [Chronic obstructive pulmonary disease (COPD) burden in Japan – confronting COPD Japan survey]. Nihon Kokyuki Gakkai Zasshi. 2007;45(12):927–935. Japanese.
4. Nakano Y, Mishima M, Nagai A, Yoshimoto D, et al. [Undiagnosed COPD in Japanese patients, aged over 40 with history of smoking and repeated chest infections, consulting in primary care]. Japan Med Assoc J. 2013;142:1093–1098. Japanese.
5. Fukuchi Y, Nishimura M, Ichinose M, et al. COPD in Japan: the Nippon COPD Epidemiology study. Respirology. 2004;9(4):458–465.
6. Agusti AGN. COPD, a multicomponent disease: implications for management. Respir Med. 2005;99(6):670–682.
7. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Global Initiative for Chronic Obstructive Lung Disease. Available from: http://www.goldcopd.com/uploads/users/files/GOLD_Report_2014_Oct30.pdf. Accessed December 15, 2014.
8. Ferguson GT, Anzueto A, Fei R, Emmett A, Knobil K, Kalberg C. Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations. Respir Med. 2008;102(8):1099–1108.
9. Ichinose M, Mishima M, Mashiko T, Nagai A. [Clinical study to evaluate the effects of changing from salmeterol to salmeterol/fluticasone propionate combination (SFC) in patients with COPD]. Kokyu. 2008; 27(11):1091–1100. Japanese.
10. Barnes NC, Qiu YS, Pavord ID, et al; SCO30005 Study Group. Antiinflammatory effects of salmeterol/fluticasone propionate in chronic obstructive lung disease. Am J Respir Crit Care Med. 2006;173(7):736–743.
11. Bourbeau J, Christodoulopoulos P, Maltais F, Yamauchi Y, Olivenstein R, Hamid Q. Effect of salmeterol/fluticasone propionate on airway inflammation in COPD: a randomised controlled trial. Thorax. 2007;62(11):938–943.
12. Sin DD, Man SFP, Marciniuk DD, et al; ABC (Advair, Biomarkers in COPD) Investigators. The effects of fluticasone with or without salmeterol on systemic biomarkers of inflammation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2008;177(11):1207–1214.
13. Yawn BP, Raphiou I, Hurley JS, Dalal AA. The role of fluticasone propionate/salmeterol combination therapy in preventing exacerbations of COPD. Int J Chron Obstruct Pulmon Dis. 2010;5:165–178.
14. Hanania NA, Darken P, Horstman D, et al. The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD. Chest. 2003;124(3):834–843.
15. Dal Negro RW, Pomari C, Tognella S, Micheletto C. Salmeterol and fluticasone 50 microg/250 microg bid in combination provides a better long-term control than salmeterol 50 microg bid alone and placebo in COPD patients already treated with theophylline. Pulm Pharmacol Ther. 2003;16(4):241–246.
16. Anzueto A, Ferguson GT, Feldman G, et al. Effect of fluticasone propionate/salmeterol (250/50) on COPD exacerbations and impact on patient outcomes. COPD. 2009;6(5):320–329.
17. MacNee W. Systemic inflammatory biomarkers and co-morbidities of chronic obstructive pulmonary disease. Ann Med. 2013;45(3):291–300.
18. Dickens JA, Miller BE, Edwards LD, Silverman EK, Lomas DA, Tal-Singer R; for the Evaluation of COPD Longitudinally to Identify Surrogate Endpoints (ECLIPSE) study Investigators. COPD association and repeatability of blood biomarkers in the ECLIPSE cohort. Respir Res. 2011;12:146.
19. Röpcke S, Holz O, Lauer G, et al. Repeatability of and relationship between potential COPD biomarkers in bronchoalveolar lavage, bronchial biopsies, serum, and induced sputum. PLoS One. 2012;7(10):e46207.
20. Bizeto L, Mazzolini AB, Ribeiro M, Stelmach R, Cukier A, Nunes MP. Interrelationship between serum and sputum inflammatory mediators in chronic obstructive pulmonary disease. Braz J Med Biol Res. 2008;41(3):193–198.
21. Singh D, Edwards L, Tal-Singer R, Rennard S. Sputum neutrophils as a biomarker in COPD: findings from the ECLIPSE study. Respir Res. 2010;11:77.
22. Paggiaro PL, Chanez P, Holz O, et al. Sputum induction. Eur Respir J Suppl. 2002;37:3s–8s.
23. Vestbo J, Anderson W, Coxson HO, et al; ECLIPSE Investigators. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE). Eur Respir J. 2008;31(4):869–873.
24. van Elteren PH. On the combination of independent two-sample tests of Wilcoxon. B Int Statist Inst. 1960;37:351–361.
25. Henderson AR. The bootstrap: a technique for data-driven statistics. Using computer-intensive analyses to explore experimental data. Clin Chim Acta. 2005;359(1–2):1–26.
26. Stănescu D, Sanna A, Veriter C, et al. Airways obstruction, chronic expectoration, and rapid decline of FEV1 in smokers are associated with increased levels of sputum neutrophils. Thorax. 1996;51(3):267–271.
27. Lin F, Nguyen CM, Wang SJ, Saadi W, Gross SP, Jeon NL. Effective neutrophil chemotaxis is strongly influenced by mean IL-8 concentration. Biochem Biophys Res Commun. 2004;319(2):576–581.
28. Sohani ZN, Strinich TX, Watson B, et al. Reproducibility of sputum differential cell counts is not affected by squamous epithelial cells. J Asthma. 2011;48(9):952–956.
29. Tsoumakidou M, Tzanakis N, Siafakas NM. Induced sputum in the investigation of airway inflammation of COPD. Respir Med. 2003;97(8):863–871.
30. Jen R, Rennard SI, Sin DD. Effects of inhaled corticosteroids on airway inflammation in chronic obstructive pulmonary disease: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2012;7:587–595.
31. Malerba M, Ricciardolo F, Radaeli A, et al. Neutrophilic inflammation and IL-8 levels in induced sputum of alpha-1-antitrypsin PiMZ subjects. Thorax. 2006;61(2):129–133.
32. Kulkarni N, Cooke MS, Grigg J. Neutrophils in induced sputum from healthy children: role of interleukin-8 and oxidative stress. Respir Med. 2007;101(10):2108–2112.
33. Ishikawa N, Hattori N, Kohno N, Kobayashi A, Hayamizu T, Johnson M. Airway inflammation in Japanese COPD patients compared with smoking and nonsmoking controls. Int J Chron Obstruct Pulmon Dis. 2015;10:185–192.
34. Barnes N. Reducing inflammation in COPD: the evidence builds. Thorax. 2007;62(11):927–928.
35. Lazarus SC, Chinchilli VM, Rollings NJ, et al; National Heart Lung and Blood Institute’s Asthma Clinical Research Network. Smoking affects response to inhaled corticosteroids or leukotriene receptor antagonists in asthma. Am J Respir Crit Care Med. 2007;175(8):783–790.