Blood eosinophils and response to maintenance chronic obstructive pulmonary disease treatment data from the FLAME Trial

American Journal of Respiratory and Critical Care Medicine

Volumn 195, Issue 9, 2017, Pages 1189-1197

  Roche, Nicolas ^a   Chapman, Kenneth R ^b   Vogelmeier, Claus F ^c   Herth, Felix J F ^d   Thach, Chau ^e   Fogel, Robert ^e   Olsson, Petter ^f   Patalano, Francesco ^e   Banerji, Donald ^e   Wedzicha, Jadwiga A ^g  

^a ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^b UNIVERSITY HEALTH NETWORK   (Canada)

^c UNIVERSITY HOSPITAL MARBURG   (Germany)

^d UNIVERSITY OF HEIDELBERG   (Germany)

^e NOVARTIS PHARMA AG   (Switzerland)

^f Novartis Sverige AB Vastra Frolunda   (Sweden)

^g NATIONAL HEART AND LUNG INSTITUTE   (United Kingdom)

Author keywords

Bronchodilation; Chronic obstructive pulmonary disease; Exacerbations; Inhaled corticosteroids; QVA149

Indexed keywords

BIOLOGICAL MARKER; FLUTICASONE PROPIONATE PLUS SALMETEROL; GLYCOPYRRONIUM BROMIDE PLUS INDACATEROL; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; CORTICOSTEROID; FLUTICASONE PROPIONATE PLUS SALMETEROL XINAFOATE; INDACATEROL; INDAN DERIVATIVE; QUINOLONE DERIVATIVE;

ADULT; AGED; ARTICLE; CARDIOVASCULAR MORTALITY; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL EVALUATION; CONTROLLED STUDY; CORRELATION ANALYSIS; DISEASE EXACERBATION; DRUG EFFICACY; EOSINOPHIL COUNT; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HEART DISEASE; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; PNEUMONIA; POST HOC ANALYSIS; PRIORITY JOURNAL; PROSPECTIVE STUDY; RISK REDUCTION; ST. GEORGE RESPIRATORY QUESTIONNAIRE; TREATMENT OUTCOME; TREATMENT RESPONSE; BLOOD; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DOUBLE BLIND PROCEDURE; DRUG EFFECTS; EOSINOPHIL; LEUKOCYTE COUNT; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RANDOMIZED CONTROLLED TRIAL;

ADRENAL CORTEX HORMONES; ADRENERGIC BETA-2 RECEPTOR AGONISTS; AGED; BIOMARKERS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; EOSINOPHILS; FEMALE; FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE DRUG COMBINATION; HUMANS; INDANS; LEUKOCYTE COUNT; MALE; MIDDLE AGED; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUINOLONES; TREATMENT OUTCOME;

EID: 85018998078     PISSN: 1073449X     EISSN: 15354970     Source Type: Journal    
DOI: 10.1164/rccm.201701-0193OC     Document Type: Article

References (45)

1. Tashkin DP, Celli B, Senn S., Burkhart D, Kesten S, Menjoge S., Decramer M; UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008; 359: 1543-1554.
2. Kerwin E, Hébert J, Gallagher N, Martin C, Overend T, Alagappan VK, Lu Y, Banerji D. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J 2012; 40:1106-1114.
3. Decramer ML, Chapman KR, Dahl R, Frith P., Devouassoux G, Fritscher C, Cameron R., Shoaib M, Lawrence D, Young D., et al.; INVIGORATE investigators. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. Lancet Respir Med 2013; 1: 524-533.
4. Wedzicha JA, Decramer M, Ficker J.H., Niewoehner DE, Sandström T, Taylor A.F., D'Andrea P, Arrasate C, Chen H., Banerji D. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med 2013; 1: 199-209.
5. Wedzicha JA, Calverley PM, Seemungal T.A., Hagan G., Ansari Z, Stockley RA; INSPIRE Investigators. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med 2008; 177:19-26.
6. Calverley PM, Anderson JA, Celli B, Ferguson G.T., Jenkins C., Jones PW, Yates JC, Vestbo J; TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007; 356:775-789.
7. Szafranski W, Cukier A, Ramirez A., Menga G, Sansores R, Nahabedian S., Peterson S, Olsson H. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J 2003; 21:74-81.
8. Calverley PM, Boonsawat W, Cseke Z., Zhong N, Peterson S, Olsson H. Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. Eur Respir J 2003; 22:912-919.
9. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease [accessed 2017 Mar 28]. Available from: http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/
10. Wedzicha JA, Banerji D, Chapman K.R., Vestbo J., Roche N, Ayers RT, Thach C, Fogel R., Patalano F, Vogelmeier CF; FLAME Investigators. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med 2016; 374:2222-2234.
11. Crim C, Calverley PM, Anderson J.A., Celli B., Ferguson GT, Jenkins C, Jones PW, Willits L.R., Yates JC, Vestbo J. Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results. Eur Respir J 2009; 34: 641-647.
12. Yawn BP, Li Y, Tian H., Zhang J, Arcona S, Kahler KH Inhaled corticosteroid use in patients with chronic obstructive pulmonary disease and the risk of pneumonia: a retrospective claims data analysis. Int J Chron Obstruct Pulmon Dis 2013; 8:295-304.
13. Price D, Yawn B, Brusselle G., Rossi A. Risk-to-benefit ratio of inhaled corticosteroids in patients with COPD. Prim Care Respir J 2013; 22: 92-100.
14. Suissa S, Coulombe J, Ernst P. Discontinuation of inhaled corticosteroids in COPD and the risk reduction of pneumonia. Chest 2015; 148:1177-1183.
15. Woodruff PG, Agusti A, Roche N., Singh D, Martinez FJ. Current concepts in targeting chronic obstructive pulmonary disease pharmacotherapy: making progress towards personalised management. Lancet 2015; 385:1789-1798.
16. Brightling CE, McKenna S, Hargadon B., Birring S, Green R, Siva R., Berry M, Parker D, Monteiro W., Pavord ID, et al. Sputum eosinophilia and the short term response to inhaled mometasone in chronic obstructive pulmonary disease. Thorax 2005; 60:193-198.
17. Leigh R, Pizzichini MM, Morris M.M., Maltais F., Hargreave FE, Pizzichini E. Stable COPD: predicting benefit from high-dose inhaled corticosteroid treatment. Eur Respir J 2006; 27:964-971.
18. Bafadhel M, McKenna S, Terry S., Mistry V, Reid C, Haldar P., McCormick M, Haldar K, Kebadze T., Duvoix A, et al. Acute exacerbations of chronic obstructive pulmonary disease: identification of biologic clusters and their biomarkers. Am J Respir Crit Care Med 2011; 184:662-671.
19. Liesker JJ, Bathoorn E, Postma D.S., Vonk JM, Timens W, Kerstjens HA. Sputum inflammation predicts exacerbations after cessation of inhaled corticosteroids in COPD. Respir Med 2011; 105:1853-1860.
20. Barnes NC, Qiu YS, Pavord I.D., Parker D., Davis PA, Zhu J, Johnson M, Thomson N.C., Jeffery PK; SCO30005 Study Group. Antiinflammatory effects of salmeterol/fluticasone propionate in chronic obstructive lung disease. Am J Respir Crit Care Med 2006; 173:736-743.
21. Lacy P, Lee JL, Vethanayagam D. Sputum analysis in diagnosis and management of obstructive airway diseases. Ther Clin Risk Manag 2005; 1:169-179.
22. Bafadhel M, McKenna S, Terry S., Mistry V, Pancholi M, Venge P., Lomas DA, Barer MR, Johnston SL, Pavord I.D., et al. Blood eosinophils to direct corticosteroid treatment of exacerbations of chronic obstructive pulmonary disease: a randomized placebo-controlled trial. Am J Respir Crit Care Med 2012; 186:48-55.
23. Eltboli O, Mistry V, Barker B., Brightling CE. Relationship between blood and bronchial submucosal eosinophilia and reticular basement membrane thickening in chronic obstructive pulmonary disease. Respirology 2015; 20:667-670.
24. Pascoe S, Locantore N, Dransfield M.T., Barnes NC, Pavord ID. Blood eosinophil counts, exacerbations, and response to the addition of inhaled fluticasone furoate to vilanterol in patients with chronic obstructive pulmonary disease: a secondary analysis of data from two parallel randomised controlled trials. Lancet Respir Med 2015; 3:435-442.
25. Hinds DR, DiSantostefano RL, Le H.V., Pascoe S. Identification of responders to inhaled corticosteroids in a chronic obstructive pulmonary disease population using cluster analysis. BMJ Open 2016; 6:e010099.
26. Siddiqui SH, Guasconi A, Vestbo J., Jones P, Agusti A, Paggiaro P., Wedzicha JA, Singh D. Blood eosinophils: a biomarker of response to extrafine beclomethasone/formoterol in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2015; 192:523-525.
27. Pavord ID, Lettis S, Locantore N., Pascoe S, Jones PW, Wedzicha J.A., Barnes NC. Blood eosinophils and inhaled corticosteroid/long-acting β-2 agonist efficacy in COPD. Thorax 2016; 71:118-125.
28. Chapman K, Vogelmeier C, FowlerTaylor A., Ayres T, Thach C, Shrinivasan A., Fogel R, Patalano F, Banerji D. Effect of indacaterol/glycopyrronium (IND/GLY) vs salmeterol/fluticasone (SFC) on moderate or severe COPD exacerbations and lung function based on baseline blood eosinophil counts: results from the FLAME study. Eur Respir J 2016; 48:PA296.
29. Anthonisen NR, Manfreda J, Warren C.P., Hershfield ES, Harding GK, Nelson NA. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med 1987; 106:196-204.
30. Vedel-Krogh S., Nielsen SF, Lange P, Vestbo J., Nordestgaard BG. Blood eosinophils and exacerbations in chronic obstructive pulmonary disease: the Copenhagen general population study. Am J Respir Crit Care Med 2016; 193:965-974.
31. Price D, Rigazio A, Postma D., Papi A, Brusselle G, Agusti A., Anzueto A, Vogelmeier C, Ryan D., Freeman D, et al. Blood eosinophilia and the number of exacerbations in COPD patients. Eur Respir J 2014; 44 (Suppl 58):4416.
32. Singh D, Kolsum U, Brightling C.E., Locantore N., Agusti A, Tal-Singer R; ECLIPSE investigators. Eosinophilic inflammation in COPD: prevalence and clinical characteristics. Eur Respir J 2014; 44:1697-1700.
33. Casaburi R, Mahler DA, Jones P.W., Wanner A., San PG, ZuWallack RL, Menjoge SS, Serby C.W., Witek T Jr. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J 2002; 19:217-224.
34. Tashkin DP, Celli B, Decramer M., Liu D, Burkhart D, Cassino C., Kesten S. Bronchodilator responsiveness in patients with COPD. Eur Respir J 2008; 31:742-750.
35. D'Urzo A., Ferguson GT, van Noord JA, Hirata K, Martin C, Horton R., Lu Y, Banerji D, Overend T. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res 2011; 12:156.
36. Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF; ACCORD I study investigators. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD 2012; 9:90-101.
37. Jones PW, Singh D, Bateman E.D., Agusti A., Lamarca R, de Miquel G, Segarra R, Caracta C., Garcia Gil E. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J 2012; 40:830-836.
38. Bateman ED, Ferguson GT, Barnes N, Gallagher N., Green Y, Henley M, Banerji D. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J 2013; 42: 1484-1494.
39. Zhong N, Wang C, Zhou X., Zhang N, Humphries M, Wang L., Thach C, Patalano F, Banerji D; LANTERN Investigators. LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. Int J Chron Obstruct Pulmon Dis 2015; 10:1015-1026.
40. Vogelmeier CF, Bateman ED, Pallante J, Alagappan V.K., D'Andrea P, Chen H, Banerji D. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respir Med 2013; 1:51-60.
41. Pavord ID, Lettis S, Anzueto A., Barnes N. Blood eosinophil count and pneumonia risk in patients with chronic obstructive pulmonary disease: a patient-level meta-analysis. Lancet Respir Med 2016; 4: 731-741.
42. Watz H, Tetzlaff K, Wouters E.F., Kirsten A., Magnussen H, Rodriguez-Roisin R, Vogelmeier C, Fabbri L.M., Chanez P., Dahl R, et al. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial. Lancet Respir Med 2016; 4: 390-398.
43. Calverley P, Tetzlaff K, Vogelmeier C., Fabbri L, Magnussen H, Wouters E., Disse B, Finnigan H, Asijee G.M., Watz H. Evaluating blood eosinophils and exacerbation history to predict ICS response in COPD. Eur Respir J 2016; 48:OA1973.
44. Calverley P, Tetzlaff K, Vogelmeier C., Fabbri L, Magnussen H, Wouters E., Disse B, Finnigan H, Asijee G.M., Watz H. Evaluating blood eosinophils and exacerbation history to predict ICS response in COPD. Presented at the European Respiratory (ERS) Society International Congress, September 3-7, 2016, London, UK. Poster OA1973.
45. ClinicalTrials.gov. NCT02164513. A study comparing the efficacy, safety and tolerability of fixed dose combination (FDC) of FF/UMEC/VI with the FDC of FF/VI and UMEC/VI; administered once-daily via a dry powder inhaler (DPI) in subjects with chronic obstructive pulmonary disease (COPD) [updated 2016 Nov 21; accessed 2017 Mar 28]. Available from http://clinicaltrials.gov/ct2/show/NCT02164513