Umeclidinium bromide + vilanterol for the treatment of chronic obstructive pulmonary disease

References

• Cazzola M, Page CP, Calzetta L, Matera MG. Pharmacology and therapeutics of bronchodilators. Pharmacol Rev 2012;64:450-504
   PubMed Web of Science ®Google Scholar
• Cazzola M, Brusasco V, Centanni S, et al. Project PriMo: sharing principles and practices of bronchodilator therapy monitoring in COPD: a consensus initiative for optimizing therapeutic appropriateness among Italian specialists. Pulm Pharmacol Ther 2013;26:218-28
   PubMed Web of Science ®Google Scholar
• Cazzola M, Molimard M. The scientific rationale for combining long-acting β2-agonists and muscarinic antagonists in COPD. Pulm Pharmacol Ther 2010;23:257-67
   PubMed Web of Science ®Google Scholar
• Meurs H, Oenema TA, Kistemaker LE, Gosens R. A new perspective on muscarinic receptor antagonism in obstructive airways diseases. Curr Opin Pharmacol 2013;13:316-23
   PubMed Web of Science ®Google Scholar
• Matera MG, Page CP, Cazzola M. Novel bronchodilators for the treatment of chronic obstructive pulmonary disease. Trends Pharmacol Sci 2011;32:495-506
   PubMed Web of Science ®Google Scholar
• Cazzola M, Rogliani P, Segreti A, Matera MG. An update on bronchodilators in Phase I and II clinical trials. Expert Opin Investig Drugs 2012;21:1489-501
   PubMed Web of Science ®Google Scholar
• Cazzola M, Page C, Matera MG. Long-acting muscarinic receptor antagonists for the treatment of respiratory disease. Pulm Pharmacol Ther 2013;26:307-17
   PubMed Web of Science ®Google Scholar
• Matera MG, Rogliani P, Cazzola M. Muscarinic receptor antagonists for the treatment of chronic obstructive pulmonary disease. Expert Opin Pharmacother 2014;15:961-77
   PubMed Web of Science ®Google Scholar
• Cazzola M, Calzetta L, Matera MG. β2-adrenoceptor agonists: current and future direction. Br J Pharmacol 2011;163:4-17
   PubMed Web of Science ®Google Scholar
• Cazzola M, Page CP, Rogliani P, Matera MG. β2-agonist therapy in lung disease. Am J Respir Crit Care Med 2013;187:690-6
   PubMed Web of Science ®Google Scholar
• Salmon M, Luttmann MA, Foley JJ, et al. Pharmacological characterization of GSK573719 (umeclidinium): a novel, long-acting, inhaled antagonist of the muscarinic cholinergic receptors for treatment of pulmonary diseases. J Pharmacol Exp Ther 2013;345:260-70
   PubMed Web of Science ®Google Scholar
• Church A, Beerahee M, Brooks J, et al. Dose response of umeclidinium administered once or twice daily in patients with COPD: a randomised cross-over study. BMC Pulm Med 2014;14:2
   PubMed Web of Science ®Google Scholar
• Trivedi R, Richard N, Mehta R, Church A. Umeclidinium in patients with COPD: a randomised, placebo-controlled study. Eur Respir J 2014;43:72-81
   PubMed Web of Science ®Google Scholar
• Tal-Singer R, Cahn A, Mehta R, et al. Initial assessment of single and repeat doses of inhaled umeclidinium in patients with chronic obstructive pulmonary disease: two randomised studies. Eur J Pharmacol 2013;701:40-8
   PubMed Web of Science ®Google Scholar
• Slack RJ, Barrett VJ, Morrison VS, et al. In vitro pharmacological characterization of vilanterol, a novel long-acting β2-adrenoceptor agonist with 24-hour duration of action. J Pharmacol Exp Ther 2013;344:218-30
   PubMed Web of Science ®Google Scholar
• Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther 2013;26:256-64
   PubMed Web of Science ®Google Scholar
• Hanania NA, Feldman G, Zachgo W, et al. The efficacy and safety of the novel long-acting β2 agonist vilanterol in patients with COPD: a randomized placebo-controlled trial. Chest 2012;142:119-27
   PubMed Web of Science ®Google Scholar
• Feldman G, Walker RR, Brooks J, et al. 28-Day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trial. Pulm Pharmacol Ther 2012;25:465-71
   PubMed Web of Science ®Google Scholar
• Mehta R, Hardes K, Cahn A, et al. Safety, tolerability and pharmacokinetics (PK) of repeated doses of GSK573719 inhalation powder, a new long-acting muscarinic antagonist, in healthy adults [abstract]. Eur Respir J 2011;38(Suppl 5):723s
   Google Scholar
• Cahn A, Lovick R, Newlands A, et al. Safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of GSK573719 inhalation powder in healthy subjects [abstract]. Eur Respir J 2011;38(Suppl 5):723s
   Google Scholar
• Goyal N, Beerahee M, Kalberg C, et al. Population pharmacokinetics of inhaled umeclidinium and vilanterol in patients with chronic obstructive pulmonary disease. Clin Pharmacokinet 2014;53:637-48
   PubMed Web of Science ®Google Scholar
• Mehta R, Hardes K, Kelleher D, et al. Effects of moderate hepatic impairment on the pharmacokinetic properties and tolerability of umeclidinium and vilanterol in inhalational umeclidinium monotherapy and umeclidinium/vilanterol combination therapy: an open-label, nonrandomized study. Clin Ther 2014;36:1016-27
   PubMed Web of Science ®Google Scholar
• Kelleher D, Hardes K, Brealey N, et al. Effect of severe renal impairment (SRI) on umeclidinium (UMEC) and vilanterol (VI) pharmacokinetics (PK) [abstract]. Eur Respir J 2013;42(Suppl 57):P4148
   Google Scholar
• Mehta R, Kelleher D, Preece A, et al. Effect of verapamil on systemic exposure and safety of umeclidinium and vilanterol: a randomized and open-label study. Int J Chron Obstruct Pulmon Dis 2013;8:159-67
   PubMed Web of Science ®Google Scholar
• Donohue JF, Maleki-Yazdi MR, Kilbride S, et al. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med 2013;107:1538-46
   PubMed Web of Science ®Google Scholar
• Celli B, Crater G, Kilbride S, et al. Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest 2014. [Epub ahead of print]
   Web of Science ®Google Scholar
• Decramer M, Anzueto A, Kerwin E, et al. Efficacy and safety of umeclidinium plus vilanterol versus tiotropium, vilanterol, or umeclidinium monotherapies over 24 weeks in patients with chronic obstructive pulmonary disease: results from two multicentre, blinded, randomised controlled trials. Lancet Respir Med 2014;2:472-86
   PubMed Web of Science ®Google Scholar
• Decramer M, Anzueto A, Richard N, et al. Effect of the once-daily long-acting bronchodilator combination umeclidinium/vilanterol (UMEC/VI) and bronchodilator monotherapy on dyspnoea as measured by the transitional dyspnoea index (TDI) in COPD. Eur Respir J 2014;44:P921
   Google Scholar
• Han MK, Kalberg C, Brooks J, Church A. Bronchodilator response to the long-acting bronchodilator combination of umeclidinium/vilanterol across subgroups of patients with COPD [abstract]. Am J Respir Crit Care Med 2014;189:A3762
   Google Scholar
• Singh D, Worsley S, Zhu CQ, et al. Umeclidinium/vilanterol (UMEC/VI) once daily (OD) vs fluticasone/salmeterol combination (FSC) twice daily (BD) in patients with moderate-to-severe COPD and infrequent COPD exacerbations. Eur Respir J 2014;44:P290
   Google Scholar
• GlaxoSmithKline. Pulmonary Allergy Drugs Advisory Committee Meeting: FDA briefing document. NDA 203-975: umeclidinium and vilanterol inhalation powder for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). 2013. Available from: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/pulmonary-allergydrugsadvisorycommittee/ucm367411.pdf [Last accessed 2 September 2014]
   Google Scholar
• Maltais F, Singh S, Donald A, et al. Effects of a combination of vilanterol and umeclidinium on exercise endurance in subjects with COPD: two randomised clinical trials [abstract]. Eur Respir J 2013;42(Suppl 57):P761
   Google Scholar
• Huisman E, Cockle S, Punekar Y. Comparative assessment of umeclidinium/vilanterol (UMEC/VI) combination therapy among symptomatic COPD patients [abstract]. Eur Respir J 2013;42:P894
   Google Scholar
• Scott LJ, Hair P. Umeclidinium/Vilanterol: first global approval. Drugs 2014;74:389-95
   PubMed Web of Science ®Google Scholar
• Kelleher D, Tombs L, Preece A, et al. A randomized, placebo- and moxifloxacin-controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects. Pulm Pharmacol Ther 2014;29:49-5
   PubMed Web of Science ®Google Scholar
• Naccarelli G, Finkle J, Chopra B, et al. Cardiovascular safety of umeclidinium/vilanterol in COPD: results from eight randomized clinical trials [abstract]. Am J Respir Crit Care Med 2014;189:A3766
   Web of Science ®Google Scholar
• Donohue JF, Niewoehner D, Brooks J, et al. Safety and tolerability of once-daily umeclidinium/vilanterol 125/25 mcg and umeclidinium 125 mcg in patients with chronic obstructive pulmonary disease: results from a 52-week, randomized, double-blind, placebo-controlled study. Respir Res 2014;15:78
   PubMed Web of Science ®Google Scholar
• Bäckman P, Adelmann H, Petersson G, Jones CB. Advances in inhaled technologies: understanding the therapeutic challenge, predicting clinical performance, and designing the optimal inhaled product. Clin Pharmacol Ther 2014;95:509-20
   PubMed Web of Science ®Google Scholar
• Hamilton M, Prime D, Bogalo Huescar M, et al. In–vitro delivery performance of umeclidinium and umeclidinium/vilanterol from a dry powder inhaler using the Electronic Lung breathing simulator to replicate inhalation profiles from patients with varying COPD severity [abstract]. Am J Respir Crit Care Med 2013;187:A4281
   Web of Science ®Google Scholar
• Svedsater H, Dale P, Garrill K, et al. Qualitative assessment of attributes and ease of use of the ELLIPTA™ dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med 2013;13:72
   PubMed Web of Science ®Google Scholar
• Sharma R, Komase Y, Akimoto A, Kobayashi A. Operability of the ELLIPTA™ dry powder inhaler: a comparative evaluation of handling technique in inhalation therapy-naïve subjects [abstract]. Am J Respir Crit Care Med 2014;189:A5693
   Google Scholar
• US Food and Drug Administration. FNA News Release. FDA approves Anoro Ellipta to treat chronic obstructive pulmonary disease. Available from: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm379057.htm [Last accessed 31 August 2014]
   Google Scholar
• CenterWatch. Anoro Ellipta (umeclidinium and vilanterol inhalation powder). Available from: https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/1300/anoro-ellipta-umeclidinium-and-vilanterol-inhalation-powder [Last accessed 5 October 2014]
   Google Scholar
• GlaxoSmithKline, Inc. Anoro Ellipta approved for COPD in Canada. Available from: http:/www. firstwordpharma. com/node/1177487? tsid= 28& region_ id= 3#axzz2qDDGAfxx [Last accessed 31 August 2014]
   Google Scholar
• Reuters Edition UK. Glaxosmithkline Plc and Theravance Inc announce Anoro (Umeclidinium/Vilanterol) gains marketing authorisation in Europe for the treatment of COPD. Available from: http://uk.reuters.com/business/quotes/GSK.L/key-developments/article/2985715 [Last accessed 31 August 2014]
   Google Scholar
• Theravance and GSK Receive Approval for Anoro Ellipta in Japan. Available from: http://www.outsourcedpharma.com/doc/theravance-and-gsk-receive-approval-for-anoro-ellipta-in-japan-0001 [Last accessed 31 August 2014]
   Google Scholar
• Cazzola M, Matera MG. Bronchodilators: current and future. Clin Chest Med 2014;35:191-201
   PubMed Web of Science ®Google Scholar
• Cazzola M, Page C. Long-acting bronchodilators in COPD: where are we now and where are we going? Breathe 2014;10:110-20
   Google Scholar
• Segreti A, Stirpe E, Rogliani P, Cazzola M. Defining phenotypes in COPD: an aid to personalized healthcare. Mol Diagn Ther 2014;18:381-8
   PubMed Web of Science ®Google Scholar
• Cazzola M, Segreti A, Bettoncelli G, et al. Change in asthma and COPD prescribing by Italian general practitioners between 2006 and 2008. Prim Care Respir J 2011;20:291-8
   PubMedGoogle Scholar
• Corrado A, Rossi A. How far is real life from COPD therapy guidelines? An Italian observational study. Respir Med 2012;106:989-97
   PubMed Web of Science ®Google Scholar
• Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of COPD. 2014. Available from: www.goldcopd.org [Last accessed 4 September 2014]
   Google Scholar
• Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med 2011;155:179-91
   PubMed Web of Science ®Google Scholar
• Cazzola M, Rogliani P, Novelli L, Matera MG. Inhaled corticosteroids for chronic obstructive pulmonary disease. Expert Opin Pharmacother 2013;14:2489-99
   PubMed Web of Science ®Google Scholar
• Miravitlles M, Calle M, Soler-Cataluna JJ. Clinical phenotypes of COPD: identification, definition and implications for guidelines. Arch Bronconeumol 2012;48:86-98
   PubMed Web of Science ®Google Scholar
• Rabe KF, Timmer W, Sagkriotis A, Viel K. Comparison of a combination of tiotropium plus formoterol to salmeterol plus fluticasone in moderate COPD. Chest 2008;134:255-62
   PubMed Web of Science ®Google Scholar
• Wedzicha JA, Decramer M, Seemungal TA. The role of bronchodilator treatment in the prevention of exacerbations of COPD. Eur Respir J 2012;40:1545-54
   PubMed Web of Science ®Google Scholar
• Cazzola M, Segreti A, Matera MG. New developments in the combination treatment of COPD: focus on umeclidinium/vilanterol. Drug Des Devel Ther 2013;7:1201-8
   PubMed Web of Science ®Google Scholar