Umeclidinium bromide and vilanterol in combination for the treatment of chronic obstructive pulmonary disease

References

• Buist AS, McBurnie MA, Vollmer WM, et al. International variation in the prevalence of COPD (the BOLD Study): a population-based prevalence study. Lancet 2007;370:741-50
   PubMed Web of Science ®Google Scholar
• Murray CJ, Lopez AD. Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease Study. Lancet 1997;349:1498-504
   PubMed Web of Science ®Google Scholar
• Zhong N, Wang C, Yao W, et al. Prevalence of chronic obstructive pulmonary disease in China: a large, population-based survey. Am J Respir Crit Care Med 2007;176:753-60
   PubMed Web of Science ®Google Scholar
• Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future trends. Lancet 2007;370:765-73
   PubMed Web of Science ®Google Scholar
• Gold PM. The 2007 GOLD Guidelines: a comprehensive care framework. Respir Care 2009;54:1040-9
   PubMed Web of Science ®Google Scholar
• O’Donnell DE, Sciurba F, Celli B, et al. Effect of fluticasone propionate/salmeterol on lung hyperinflation and exercise endurance in COPD. Chest 2006;130:647-56
   PubMed Web of Science ®Google Scholar
• O’Donnell DE, Fluge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J 2004;23:832-40
   PubMed Web of Science ®Google Scholar
• Tashkin DP, Pearle J, Iezzoni D, Varghese ST. Formoterol and tiotropium compared with tiotropium alone for treatment of COPD. COPD 2009;6:17-25
   PubMedGoogle Scholar
• van Noord JA, Aumann JL, Janssens E, et al. Comparison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD. Eur Respir J 2005;26:214-22
   PubMed Web of Science ®Google Scholar
• Curtis JL, Freeman CM, Hogg JC. The immunopathogenesis of chronic obstructive pulmonary disease: insights from recent research. Proc Am Thorac Soc 2007;4:512-21
   PubMedGoogle Scholar
• Spina D. Current and novel bronchodilators in respiratory disease. Curr Opin Pulm Med 2014;20:73-86
   PubMed Web of Science ®Google Scholar
• Vauquelin G, Charlton SJ. Long-lasting target binding and rebinding as mechanisms to prolong in vivo drug action. Br J Pharmacol 2010;161:488-508
   PubMed Web of Science ®Google Scholar
• Casarosa P, Kiechle T, Sieger P, et al. The constitutive activity of the human muscarinic M3 receptor unmasks differences in the pharmacology of anticholinergics. J Pharmacol Exp Ther 2010;333:201-9
   PubMed Web of Science ®Google Scholar
• Roffel AF, Elzinga CR, Zaagsma J. Muscarinic M3 receptors mediate contraction of human central and peripheral airway smooth muscle. Pulm Pharmacol 1990;3:47-51
   PubMedGoogle Scholar
• Brusasco V. Reducing cholinergic constriction: the major reversible mechanism in COPD. Eur Respir Rev 2006;15:32-6
   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
• Cahn A, Tal-Singer R, Pouliquen IJ, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat inhaled doses of umeclidinium in healthy subjects: two randomized studies. Clin Drug Investig 2013;33:477-88
   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
• Donohue JF, Anzueto A, Brooks J, et al. A randomized, double-blind dose-ranging study of the novel LAMA GSK573719 in patients with COPD. Respir Med 2012;106:970-9
   PubMed Web of Science ®Google Scholar
• Decramer M, Maltais F, Feldman G, et al. Bronchodilation of umeclidinium, a new long-acting muscarinic antagonist, in COPD patients. Respir Physiol Neurobiol 2013;185:393-9
   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
• Laine D, Luttmann M, Foley J, et al. The pre-clinical pharmacology of the inhaled muscarinic antagonist GSK573719 predicts once-daily clinical dosing. Eur Respir J 2011
   Google Scholar
• Jones PW, Barnes N, Vogelmeier C, et al. Efficacy of indacaterol in the treatment of patients with COPD. Prim Care Respir J 2011;20:380-8
   PubMedGoogle Scholar
• Slack RJ, Barrett VJ, Morrison VS, et al. In vitro pharmacological characterization of vilanterol, a novel long-acting beta2-adrenoceptor agonist with 24-hour duration of action. J Pharmacol Exp Ther 2013;344:218-30
   PubMed Web of Science ®Google Scholar
• Morrison V, Sturton G, Barrett V, et al. A pharmacological characterisation of GW642444, a long-acting β2-agonist (LABA) with rapid onset and long duration, on isolated large and small human airways. Am J Respir Crit Care Med 2010;181:A4453
   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 beta2 agonist vilanterol in patients with COPD: a randomized placebo-controlled trial. Chest 2012;142:119-27
   PubMed Web of Science ®Google Scholar
• Boscia JA, Pudi KK, Zvarich MT, et al. Effect of once-daily fluticasone furoate/vilanterol on 24-hour pulmonary function in patients with chronic obstructive pulmonary disease: a randomized, three-way, incomplete block, crossover study. Clin Ther 2012;34:1655-66.e5
   PubMed Web of Science ®Google Scholar
• Kelleher DL, Mehta RS, Jean-Francois BM, et al. Safety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: a randomized crossover trial. PLoS One 2012;7:e50716
   PubMed Web of Science ®Google Scholar
• Kainu A, Lindqvist A, Sarna S, et al. FEV1 response to bronchodilation in an adult urban population. Chest 2008;134:387-93
   PubMed Web of Science ®Google Scholar
• Albert P, Agusti A, Edwards L, et al. Bronchodilator responsiveness as a phenotypic characteristic of established chronic obstructive pulmonary disease. Thorax 2012;67:701-8
   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
• 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
• 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
• Kelleher D, Tombs L, Crater G, et al. A placebo- and moxifloxacin-controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects. American Thoracic Society International Conference (ATS); 2013. Philadelphia, USA
   Google Scholar
• Anzueto A, Decramer M, Kaelin T, et al. The efficacy and safety of umeclidinium/vilanterol compared with tiotropium in COPD. Annual Congress of the American Thoracic Society; 2013. Philadelphia, PA, USA
   Google Scholar
• Decramer M, Anzueto A, Kerwin E, et al. Efficacy and safety of umeclidinium/vilanterol compared with umeclidinium or tiotropium in COPD. European Respiratory Society (ERS) Annual Congress; 2013. Barcelona, Spain
   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
• Donohue J, Niewoehner D, Brooks J, et al. Long-term safety and tolerability of umeclidinium/vilanterol and umeclidinium in COPD. Annual Congress of the European Respiratory Society (ERS); 2013. Barcelona, Spain
   Google Scholar
• Global strategy for diagnosis, management, and prevention of COPD. 2014. Available from: www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. [ Last accessed 14 February 2014]
   Google Scholar
• Suissa S, Barnes PJ. Inhaled corticosteroids in COPD: the case against. Eur Respir J 2009;34:13-16
   PubMed Web of Science ®Google Scholar
• Calverley PM, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007;356:775-89
   PubMed Web of Science ®Google Scholar
• Suissa S, Ernst P, Vandemheen KL, Aaron SD. Methodological issues in therapeutic trials of COPD. Eur Respir J 2008;31:927-33
   PubMed Web of Science ®Google Scholar
• La Vecchia C, Fabbri LM. Prevention of death in COPD. N Engl J Med 2007;356:2211-12; author reply 3-4
   PubMed Web of Science ®Google Scholar
• D’Urzo A, Ferguson GT, van Noord JA, et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res 2011;12:156
   PubMed Web of Science ®Google Scholar
• Beeh KM, Singh D, Di Scala L, Drollmann A. Once-daily NVA237 improves exercise tolerance from the first dose in patients with COPD: the GLOW3 trial. Int J Chron Obstruct Pulmon Dis 2012;7:503-13
   PubMed Web of Science ®Google Scholar
• Kerwin E, Hebert J, Gallagher N, et al. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J 2012;40:1106-14
   PubMed Web of Science ®Google Scholar
• Dahl R, Chung KF, Buhl R, et al. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax 2010;65:473-9
   PubMed Web of Science ®Google Scholar
• Donohue JF, Fogarty C, Lotvall J, et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med 2010;182:155-62
   PubMed Web of Science ®Google Scholar
• Buhl R, Dunn LJ, Disdier C, et al. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J 2011;38:797-803
   PubMed Web of Science ®Google Scholar
• Chapman KR, Rennard SI, Dogra A, et al. Long-term safety and efficacy of indacaterol, a long-acting beta(2)-agonist, in subjects with COPD: a randomized, placebo-controlled study. Chest 2011;140:68-75
   PubMed Web of Science ®Google Scholar
• Vogelmeier CF, Bateman ED, Pallante J, et al. 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
   PubMed Web of Science ®Google Scholar
• Wedzicha JA, Decramer M, Ficker JH, et al. 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
   PubMed Web of Science ®Google Scholar
• Dahl R, Chapman KR, Rudolf M, et al. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir Med 2013;107:1558-67
   PubMed Web of Science ®Google Scholar
• Dahl R, Jadayel D, Alagappan VK, et al. Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study. Int J Chron Obstruct Pulmon Dis 2013;8:501-8
   PubMed Web of Science ®Google Scholar
• Riley J, Tabberer M, Richard N, et al. Use of a new dry powder inhaler to deliver umeclidinium/vilanterol in the treatment of COPD. European Respiratory Society Annual Congress; 2013. Barcelona, Spain
   Google Scholar
• Hamilton M, Prime D, Heuscar MB, 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. American Thoracic Society International Conference; 2013. Philadelphia, Pennsylvania, USA
   Google Scholar
• Wielders PL, Ludwig-Sengpiel A, Locantore N, et al. A new class of bronchodilator improves lung function in COPD: a trial with GSK961081. Eur Respir J 2013;42:972-81
   PubMed Web of Science ®Google Scholar
• Hogg JC, Chu F, Utokaparch S, et al. The nature of small-airway obstruction in chronic obstructive pulmonary disease. N Engl J Med 2004;350:2645-53
   PubMed Web of Science ®Google Scholar
• Kelly E, Owen CA, Pinto-Plata V, Celli BR. The role of systemic inflammatory biomarkers to predict mortality in chronic obstructive pulmonary disease. Expert Rev Respir Med 2013;7:57-64
   PubMed Web of Science ®Google Scholar