Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Improves Exacerbation Outcomes in Patients with COPD without a Recent Exacerbation History: A Subgroup Analysis of KRONOS

References

• Global Initiative for Chronic Obstructive Lung Disease. 2020 Report. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease; 2020. Available from: https://goldcopd.org/wp-content/uploads/2019/11/GOLD-2020-REPORT-ver1.0wms.pdf. Accessed January 28, 2020.
   Google Scholar
• Price D, Miravitlles M, Pavord I, et al. First maintenance therapy for COPD in the UK between 2009 and 2012: a retrospective database analysis. NPJ Prim Care Respir Med. 2016;26(1):16061. doi:10.1038/npjpcrm.2016.61
   PubMedGoogle Scholar
• Wei YF, Kuo PH, Tsai YH, et al. Factors associated with the prescription of inhaled corticosteroids in GOLD group A and B patients with C. Int J Chron Obstruct Pulmon Dis. 2015;10(10):1951–1956. doi:10.2147/COPD.S88114
   PubMedGoogle Scholar
• Papi A, Vestbo J, Fabbri L, et al. Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial. Lancet. 2018;391(10125):1076–1084. doi:10.1016/S0140-6736(18)30206-X
   PubMed Web of Science ®Google Scholar
• Singh D, Papi A, Corradi M, et al. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting β2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet. 2016;388(10048):963–973. doi:10.1016/S0140-6736(16)31354-X
   PubMed Web of Science ®Google Scholar
• Vestbo J, Papi A, Corradi M, et al. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. Lancet. 2017;389(10082):1919–1929. doi:10.1016/S0140-6736(17)30188-5
   PubMed Web of Science ®Google Scholar
• Lipson DA, Barnacle H, Birk R, et al. FULFIL trial: once-daily triple therapy for patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2017;196(4):438–446. doi:10.1164/rccm.201703-0449OC
   PubMed Web of Science ®Google Scholar
• Lipson DA, Barnhart F, Brealey N, et al. Once-daily single-inhaler triple versus dual therapy in patients with COPD. N Engl J Med. 2018;378(18):1671–1680. doi:10.1056/NEJMoa1713901
   PubMed Web of Science ®Google Scholar
• Rabe KF, Martinez FJ, Ferguson GT, et al. Triple inhaled therapy at two glucocorticoid doses in moderate-to-very-severe COPD. N Engl J Med. 2020;383(1):35–48. doi:10.1056/NEJMoa1916046
   PubMed Web of Science ®Google Scholar
• Ferguson GT, Rabe KF, Martinez FJ, et al. Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, Phase 3 randomised controlled trial. Lancet Respir Med. 2018;6(10):747–758. doi:10.1016/S2213-2600(18)30327-8
   PubMed Web of Science ®Google Scholar
• Anthonisen NR, Manfreda J, Warren CP, Hershfield ES, Harding GK, Nelson NA. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 1987;106(2):196–204. doi:10.7326/0003-4819-106-2-196
   PubMed Web of Science ®Google Scholar
• Halpin DMG, Birk R, Brealey N, et al. Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses. ERJ Open Res. 2018;4(2):00119–2017. doi:10.1183/23120541.00119-2017
   PubMedGoogle Scholar
• Han MK, Quibrera PM, Carretta EE, et al. Frequency of exacerbations in patients with chronic obstructive pulmonary disease: an analysis of the SPIROMICS cohort. Lancet Respir Med. 2017;5(8):619–626. doi:10.1016/S2213-2600(17)30207-2
   PubMed Web of Science ®Google Scholar
• Ding B, Small M, Holmgren U. A cross-sectional survey of current treatment and symptom burden of patients with COPD consulting for routine care according to GOLD 2014 classifications. Int J Chron Obstruct Pulmon Dis. 2017;12:1527–1537. doi:10.2147/COPD.S133793
   PubMed Web of Science ®Google Scholar
• Brusselle G, Price D, Gruffydd-Jones K, et al. The inevitable drift to triple therapy in COPD: an analysis of prescribing pathways in the UK. Int J Chron Obstruct Pulmon Dis. 2015;10:2207–2217. doi:10.2147/COPD.S91694
   PubMed Web of Science ®Google Scholar
• Savran O, Godtfredsen N, Sørensen T, Jensen C, Ulrik CS. COPD patients prescribed inhaled corticosteroid in general practice: based on disease characteristics according to guidelines? Chron Respir Dis. 2019;16:1479973119867949. doi:10.1177/1479973119867949
   Web of Science ®Google Scholar
• Graf J, Jörres RA, Lucke T, Nowak D, Vogelmeier CF, Ficker JH. Medical Treatment of COPD: an analysis of guideline-adherent prescribing in a large national cohort (COSYCONET). Dtsch Arztebl Int. 2018;155(37):599–605. doi:10.3238/arztebl.2018.0599
   PubMedGoogle Scholar
• Lane DC, Stemkowski S, Stanford RH, Tao Z. Initiation of triple therapy with multiple inhalers in chronic obstructive pulmonary disease: an analysis of treatment patterns from a U.S. retrospective database study. J Manag Care Spec Pharm. 2018;24(11):1165–1172. doi:10.18553/jmcp.2018.24.11.1165
   PubMed Web of Science ®Google Scholar
• Magnussen H, Disse B, Rodriguez-Roisin R, et al. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014;371(14):1285–1294. doi:10.1056/NEJMoa1407154
   PubMed Web of Science ®Google Scholar
• Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med. 2016;374(23):2222–2234. doi:10.1056/NEJMoa1516385
   PubMed Web of Science ®Google Scholar
• Roche N, Chapman KR, Vogelmeier CF, et al. Blood eosinophils and response to maintenance chronic obstructive pulmonary disease treatment. Data from the FLAME trial. Am J Respir Crit Care Med. 2017;195(9):1189–1197. doi:10.1164/rccm.201701-0193OC
   PubMed Web of Science ®Google Scholar
• 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. 2015;192(4):523–525. doi:10.1164/rccm.201502-0235LE
   PubMed Web of Science ®Google Scholar
• Pascoe S, Barnes N, Brusselle G, et al. Blood eosinophils and treatment response with triple and dual combination therapy in chronic obstructive pulmonary disease: analysis of the IMPACT trial. Lancet Respir Med. 2019;7(9):745–756. doi:10.1016/S2213-2600(19)30190-0
   PubMed Web of Science ®Google Scholar
• 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. 2015;3(6):435–442. doi:10.1016/S2213-2600(15)00106-X
   PubMed Web of Science ®Google Scholar
• Anzueto A. Impact of exacerbations on COPD. Eur Respir Rev. 2010;19(116):113–118. doi:10.1183/09059180.00002610
   PubMedGoogle Scholar
• Halpin DMG, Decramer M, Celli BR, Mueller A, Metzdorf N, Tashkin DP. Effect of a single exacerbation on decline in lung function in COPD. Respir Med. 2017;128:85–91. doi:10.1016/j.rmed.2017.04.013
   PubMed Web of Science ®Google Scholar
• Donaldson GC, Seemungal TAR, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002;57(10):847–852. doi:10.1136/thorax.57.10.847
   PubMed Web of Science ®Google Scholar
• Dransfield MT, Kunisaki KM, Strand MJ, et al. Acute exacerbations and lung function loss in smokers with and without chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2017;195(3):324–330. doi:10.1164/rccm.201605-1014OC
   PubMed Web of Science ®Google Scholar
• Soler-Cataluña JJ, Martínez-García MA, Román Sánchez P, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax. 2005;60(11):925–931. doi:10.1136/thx.2005.040527
   PubMed Web of Science ®Google Scholar
• Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural history of chronic obstructive pulmonary disease exacerbations in a general practice-based population with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;198(4):464–471. doi:10.1164/rccm.201710-2029OC
   PubMed Web of Science ®Google Scholar
• Suissa S, Dell’Aniello S, Ernst P. Long-term natural history of chronic obstructive pulmonary disease: severe exacerbations and mortality. Thorax. 2012;67(11):957–963. doi:10.1136/thoraxjnl-2011-201518
   PubMed Web of Science ®Google Scholar
• Battisti WP, Wager E, Baltzer L, et al. Good publication practice for communicating company-sponsored medical research: GPP3. Ann Intern Med. 2015;163(6):461–464. doi:10.7326/M15-0288
   PubMed Web of Science ®Google Scholar