Glycopyrrolate and formoterol fumarate for the treatment of COPD

References

• Global Initiative for Chronic Obstructive Lung Disease. Global initiative for chronic obstructive lung disease report 2020 [Internet]. 2020 [cited 2020 Apr 2]. Available from: http://goldcopd.org/
   Google Scholar
• Soriano JB, Abajobir AA, Abate KH, et al. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990–2015: a systematic analysis for the global burden of disease study 2015. Lancet Respir Med. 2017;5:691–706.
   PubMed Web of Science ®Google Scholar
• Wang C, Xu J, Yang L, et al. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China pulmonary health [CPH] study): a national cross-sectional study. Lancet. 2018;391:1706–1717.
   PubMed Web of Science ®Google Scholar
• Criner GJ, Celli BR, Brightling CE, et al. Benralizumab for the prevention of COPD exacerbations. N Engl J Med. 2019;381:1023–1034.
   PubMed Web of Science ®Google Scholar
• Ohgoda O, Robinson IN. Toxicological evaluation of DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine). Fundam Toxicol Sci. 2020;7:55–76.
   Google Scholar
• Doty A, Schroeder J, Vang K, et al. Drug delivery from an innovative LAMA/LABA co-suspension delivery technology fixed-dose combination mdi: evidence of consistency, robustness, and reliability. AAPS PharmSciTech [ Internet]. 2018;19:837–844. Available from: http://dx.doi.org/10.1208/s12249-017-0891-1
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Assessment report - Bevespi Aerosphere [Internet]. 2018 [cited 2020 Apr 2]. Available from: https://www.ema.europa.eu
   Google Scholar
• Taylor G, Warren S, Dwivedi S, et al. Gamma scintigraphic pulmonary deposition study of glycopyrronium/formoterol metered dose inhaler formulated using co-suspension delivery technology. Eur J Pharm Sci [ Internet]. 2018;111:450–457. Available from: https://doi.org/10.1016/j.ejps.2017.10.026
   PubMed Web of Science ®Google Scholar
• Corcoran TE. Imaging in aerosol medicine. Respir Care. 2015;60:850–855.
   PubMed Web of Science ®Google Scholar
• Lipworth BJ, Collier DJ, Gon Y, et al. Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: A randomized phase III study conducted in Asia, Europe, and the USA. Int J COPD. 2018;13:2969–2984.
   Google Scholar
• Martinez FJ, Rabe KF, Ferguson GT, et al. Efficacy and safety of glycopyrrolate/formoterol metered dose inhaler formulated using co-suspension delivery technology in patients with COPD. Chest [ Internet]. 2017;151:340–357. Available from: http://dx.doi.org/10.1016/j.chest.2016.11.028
   PubMed Web of Science ®Google Scholar
• Hanania NA, Tashkin DP, Kerwin EM, et al. Long-term safety and efficacy of glycopyrrolate/formoterol metered dose inhaler using novel co-suspensionTM delivery technology in patients with chronic obstructive pulmonary disease. Respir Med [ Internet]. 2017;126:105–115. Available from: http://dx.doi.org/10.1016/j.rmed.2017.03.015
   PubMed Web of Science ®Google Scholar
• De Backer W, De Backer J, Vos W, et al. A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD. Int J COPD. 2018;13:2673–2684.
   Google Scholar
• Reisner C, Gottschlich G, Fakih F, et al. 24-h bronchodilation and inspiratory capacity improvements with glycopyrrolate/formoterol fumarate via co-suspension delivery technology in COPD. Respir Res. 2017;18:1–11.
   PubMed Web of Science ®Google Scholar
• Ferguson GT, Reisner C, Pearle J, et al. Cardiovascular safety profile of a fixed-dose combination of glycopyrrolate and formoterol fumarate delivered via metered dose inhaler using co-suspension delivery technology. Pulm Pharmacol Ther [ Internet]. 2018;49:67–74. Available from: https://doi.org/10.1016/j.pupt.2018.01.007
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Annex I: summary of product characteristics - Bevespi aerosphere [Internet]. 2019 [cited 2020 Apr 2]. Available from: https://www.ema.europa.eu/
   Google Scholar
• Ferguson GT, Rodriguez-Roisin R, Reisner C, et al. Pharmacokinetics of glycopyrronium/formoterol fumarate dihydrate delivered via metered dose inhaler using co-suspension delivery technology in patients with moderate-to-very severe COPD. Int J COPD. 2018;13:945–953.
   Google Scholar
• Reisner C, Miller J, DePetrillo P, et al. Pharmacokinetics and safety of a single dose of the novel LAMA/LABA fixed-dose combination of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler, formulated using co-suspension delivery technology, in Japanese healthy subjects. Pulm Pharmacol Ther [ Internet]. 2018;53:33–38. Available from: https://doi.org/10.1016/j.pupt.2018.09.005
   PubMed Web of Science ®Google Scholar
• Fakih F, Spangenthal S, Sigal B, et al. Randomized study of the effects of aerochamber plus® flow-vu® on the efficacy, pharmacokinetics and safety of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler in patients with chronic obstructive pulmonary disease. Respir Med [ Internet]. 2018;138:74–80. Available from: https://doi.org/10.1016/j.rmed.2018.03.033
   PubMed Web of Science ®Google Scholar
• Dumitras S, Sechaud R, Drollmann A, et al. Effect of cimetidine, a model drug for inhibition of the organic cation transport (OCT2/MATE1) in the kidney, on the pharmacokinetics of glycopyrronium. Int J Clin Pharmacol Ther. 2013;51:771–779.
   PubMed Web of Science ®Google Scholar
• Mariotti F, Ciurlia G, Spaccapelo L, et al. A two-period open-label, single-dose crossover study in healthy volunteers to evaluate the drug–drug interaction between cimetidine and inhaled extrafine CHF 5993. Eur J Drug Metab Pharmacokinet. 2017;42:269–279.
   PubMed Web of Science ®Google Scholar
• Kerwin EM, Spangenthal S, Kollar C, et al. A phase IIb randomized, chronic-dosing, incomplete block, cross-over study of glycopyrronium, delivered via metered dose inhaler, compared with a placebo and an active control in patients with moderate-to-severe COPD. Respir Res. 2018;19:1–13.
   PubMed Web of Science ®Google Scholar
• Reisner C, Fabbri LM, Kerwin EM, et al. A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel co-suspensionTM delivery technology in patients with moderate-to-very severe chronic obstructive. Respir Res [ Internet]. 2017;18:1–13. Available from: http://dx.doi.org/10.1186/s12931-016-0491-8
   PubMed Web of Science ®Google Scholar
• Reisner C, Pearle J, Kerwin EM, et al. Efficacy and safety of four doses of glycopyrrolate/formoterol fumarate delivered via a metered dose inhaler compared with the monocomponents in patients with moderate-to-severe COPD. Int J COPD. 2018;13:1965–1977.
   Google Scholar
• Tashkin DP, Martinez FJ, Rodriguez-Roisin R, et al. A multicenter, randomized, double-blind dose-ranging study of glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler compared to the monocomponents and open-label tiotropium dry powder inhaler in patients with moderate-to-severe CO. Respir Med [ Internet]. 2016;120:16–24. Available from: http://dx.doi.org/10.1016/j.rmed.2016.09.012
   PubMed Web of Science ®Google Scholar
• Maltais F, Ferguson GT, Feldman GJ, et al. A randomized, double-blind, double-dummy study of glycopyrrolate/formoterol fumarate metered dose inhaler relative to umeclidinium/vilanterol dry powder inhaler in COPD. Adv Ther. 2019;36:2434–2449.
   PubMed Web of Science ®Google Scholar
• Martinez FJ, Fabbri LM, Ferguson GT, et al. Baseline symptom score impact on benefits of glycopyrrolate/formoterol metered dose inhaler in COPD. Chest [Internet]. 2017;152:1169–1178. Available from: https://doi.org/10.1016/j.chest.2017.07.007
   PubMed Web of Science ®Google Scholar
• Center for Drug Evaluation and Research. Approval letter for Bevespi [Internet]. 2016 [cited 2020 Apr 2]. Available from: http://www.accessdata.fda.gov
   Google Scholar
• Pharmaceuticals and Medical Devices Agency. New drugs approved in april 2019 - november 2019 [Internet]. 2019 [cited 2020 Apr 2]. Available from: https://www.pmda.go.jp
   Google Scholar
• Magnussen H, Disse B, Rodriguez-Roisin R, et al. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014;371:1285–1294.
   PubMed Web of Science ®Google Scholar
• Watz H, Tetzlaff K, Wouters EFM, 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 [ Internet]. 2016;4:390–398. Available from: http://dx.doi.org/10.1016/S2213-2600(16)00100-4
   PubMed Web of Science ®Google 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;391:1076–1084.
   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;389:1919–1929.
   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 tr. Lancet Respir Med [ Internet]. 2018;6:747–758. Available from: http://dx.doi.org/10.1016/S2213-2600(18)30327-8
   PubMed Web of Science ®Google Scholar
• Rabe KF, Martinez FJ, Ferguson GT, et al. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 μg and 160/18/9.6 μg using co-suspension delivery technology in moderate-to-very severe COPD: the ETHOS study protocol. Respir Med [ Internet]. 2019;158:59–66. Available from: https://doi.org/10.1016/j.rmed.2019.08.010
   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;383:35–48.
   PubMed Web of Science ®Google Scholar