Predictors of exacerbation risk and response to budesonide in patients with chronic obstructive pulmonary disease: a post-hoc analysis of three randomised trials

The Lancet Respiratory Medicine

Volumn 6, Issue 2, 2018, Pages 117-126

  Bafadhel, Mona ^a   Peterson, Stefan ^b   De Blas, Miguel A ^c   Calverley, Peter M ^d   Rennard, Stephen I ^c,e   Richter, Kai ^c,f   Fagerås, Malin ^f  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b StatMind   (Sweden)

^c ASTRAZENECA   (United Kingdom)

^d UNIVERSITY OF LIVERPOOL   (United Kingdom)

^e UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^f ASTRAZENECA R AND D   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; BRONCHODILATING AGENT; BUDESONIDE; CORTICOSTEROID; FORMOTEROL; LONG ACTING DRUG;

ADULT; AGED; ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; DISEASE EXACERBATION; DRUG EFFICACY; EOSINOPHIL COUNT; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HEALTH STATUS; HUMAN; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; POST HOC ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REGRESSION ANALYSIS; SCORING SYSTEM; ST. GEORGE RESPIRATORY QUESTIONNAIRE; TREATMENT RESPONSE; VERY ELDERLY; BLOOD; CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; EOSINOPHIL; MIDDLE AGED; MULTICENTER STUDY; RISK; THERAPY;

ADULT; AGED; AGED, 80 AND OVER; BRONCHODILATOR AGENTS; BUDESONIDE; DOUBLE-BLIND METHOD; EOSINOPHILS; FEMALE; HUMANS; MALE; MIDDLE AGED; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RISK; THERAPEUTICS;

EID: 85040460999     PISSN: 22132600     EISSN: 22132619     Source Type: Journal    
DOI: 10.1016/S2213-2600(18)30006-7     Document Type: Article

References (29)

1. Global Initiative for Chronic Obstructive Lung Disease, Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease, 2017 http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/ (accessed March 1, 2017).
2. Price, D, West, D, Brusselle, G, et al. Management of COPD in the UK primary-care setting: an analysis of real-life prescribing patterns. Int J Chron Obstruct Pulmon Dis 9 (2014), 889–904.
3. Agarwal, R, Aggarwal, AN, Gupta, D, Jindal, SK, Inhaled corticosteroids vs placebo for preventing COPD exacerbations: a systematic review and meta regression of randomized controlled trials. Chest 137 (2010), 318–325.
4. Ernst, P, Saad, N, Suissa, S, Inhaled corticosteroids in COPD: the clinical evidence. Eur Respir J 45 (2015), 525–537.
5. Suissa, S, Patenaude, V, Lapi, F, Ernst, P, Inhaled corticosteroids in COPD and the risk of serious pneumonia. Thorax 68 (2013), 1029–1036.
6. Bafadhel, M, Pavord, ID, Russell, REK, Eosinophils in COPD: just another biomarker?. Lancet Respir Med 5 (2017), 747–759.
7. Pascoe, S, Locantore, N, Dransfield, MT, 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 3 (2015), 435–442.
8. Siddiqui, SH, Guasconi, A, Vestbo, J, et al. Blood eosinophils: a biomarker of response to extrafine beclomethasone/formoterol in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 192 (2015), 523–525.
9. Watz, H, Tetzlaff, K, Wouters, EF, 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 4 (2016), 390–398.
10. Make, BJ, Eriksson, G, Calverley, PM, et al. A score to predict short-term risk of COPD exacerbations (SCOPEX). Int J Chron Obstruct Pulmon Dis 10 (2015), 201–209.
11. Tashkin, DP, Rennard, SI, Martin, P, et al. Efficacy and safety of budesonide and formoterol in one pressurized metered-dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease: results of a 6-month randomized clinical trial. Drugs 68 (2008), 1975–2000.
12. Rennard, SI, Tashkin, DP, McElhattan, J, et al. Efficacy and tolerability of budesonide/formoterol in one hydrofluoroalkane pressurized metered-dose inhaler in patients with chronic obstructive pulmonary disease: results from a 1-year randomized controlled clinical trial. Drugs 69 (2009), 549–565.
13. Sharafkhaneh, A, Southard, JG, Goldman, M, Uryniak, T, Martin, UJ, Effect of budesonide/formoterol pMDI on COPD exacerbations: a double-blind, randomized study. Respir Med 106 (2012), 257–268.
14. Harrell, FE Jr, rms: regression modeling strategies. R package version 4.5-0, 2016 https://CRAN.R-project.org/package=rms (accessed May 2, 2017).
15. 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 Resp Crit Care Med 193 (2016), 965–974.
16. Kerkhof, M, Sonnappa, S, Postma, DS, et al. Blood eosinophil count and exacerbation risk in patients with COPD. Eur Respir J, 50, 2017 pii 1700761.
17. Hinds, DR, DiSantostefano, RL, Le, HV, Pascoe, S, Identification of responders to inhaled corticosteroids in a chronic obstructive pulmonary disease population using cluster analysis. BMJ Open, 6, 2016, e010099.
18. Bafadhel, M, McKenna, S, Terry, S, et al. Acute exacerbations of chronic obstructive pulmonary disease: identification of biologic clusters and their biomarkers. Am J Respir Crit Care Med 184 (2011), 662–671.
19. Brightling, CE, McKenna, S, Hargadon, B, et al. Sputum eosinophilia and the short term response to inhaled mometasone in chronic obstructive pulmonary disease. Thorax 60 (2005), 193–198.
20. Felarca, AB, Lowell, FC, The total eosinophil count in a nonatopic population. J Allergy 40 (1967), 16–20.
21. Britton, J, Pavord, I, Richards, K, et al. Factors influencing the occurrence of airway hyperreactivity in the general population: the importance of atopy and airway calibre. Eur Respir J 7 (1994), 881–887.
22. Bafadhel, M, McKenna, S, Terry, S, 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 186 (2012), 48–55.
23. Pavord, ID, Chanez, P, Criner, GJ, et al. Mepolizumab for eosinophilic chronic obstructive pulmonary disease. N Engl J Med 377 (2017), 1613–1629.
24. 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 4 (2016), 731–741.
25. Donohue, JF, Worsley, S, Zhu, CQ, Hardaker, L, Church, A, Improvements in lung function with umeclidinium/vilanterol versus fluticasone propionate/salmeterol in patients with moderate-to-severe COPD and infrequent exacerbations. Respir Med 109 (2015), 870–881.
26. Vogelmeier, C, Dahl, R, D'Urzo, T, Chen, P, Green, Y, Banerji, D, Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes versus placebo, indacaterol, glycopyrronium, tiotropium and salmeterol/fluticasone in patients with COPD. Am J Respir Crit Care Med, 187, 2013, A4270.
27. Vogelmeier, C, Paggiaro, PL, Dorca, J, et al. Efficacy and safety of aclidinium/formoterol versus salmeterol/fluticasone: a phase 3 COPD study. Eur Respir J 48 (2016), 1030–1039.
28. Wedzicha, JA, Banerji, D, Chapman, KR, et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med 374 (2016), 2222–2234.
29. Zhong, N, Wang, C, Zhou, X, et al. LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. Int J Chron Obstruct Pulmon Dis 10 (2015), 1015–1026.