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Articles

Long-term safety of once-daily indacaterol acetate/glycopyrronium bromide/mometasone furoate high-dose, and indacaterol acetate/mometasone furoate high-dose, in Japanese patients with inadequately controlled asthma: Results from two open-label, 52-week studies

, MD, PhD, , MD, , MD, , MSc, , MSc, , MSc, , MSc & , MD show all
Pages 403-411 | Received 29 Sep 2021, Accepted 17 Mar 2022, Published online: 30 May 2022

References

  • Adachi M, Hozawa S, Nishikawa M, Yoshida A, Jinnai T, Tamura G. Asthma control and quality of life in a real-life setting: a cross-sectional study of adult asthma patients in Japan (ACQUIRE-2). J Asthma. 2019;56(9):1016–1025. doi:10.1080/02770903.2018.1514628.
  • Ichinose M, Sugiura H, Nagase H, Yamaguchi M, Inoue H, Sagara H, Tamaoki J, Tohda Y, Munakata M, Yamauchi K, et al. Japanese guidelines for adult asthma 2017. Allergol Int. 2017;66(2):163–189. doi:10.1016/j.alit.2016.12.005.
  • Global strategy for asthma management and prevention. 2021. Available from: https://ginasthma.org/. [last accessed 21 Aug 2021].
  • Lipworth BJ. Emerging role of long acting muscarinic antagonists for asthma. Br J Clin Pharmacol. 2014;77(1):55–62. doi:10.1111/bcp.12123.
  • , Cloutier M, Baptist A, Blake K, Brooks E, Bryant-Stephens T, DiMango E, Dixon A, Elward K, Hartert T, Krishnan J, et al. 2020 Focused updates to the asthma management guidelines: a report from the national asthma education and prevention program coordinating committee expert panel working group. J Allergy Clin Immunol. 2020;146(6):1217–1270. Decdoi:10.1016/j.jaci.2020.10.003.
  • Marceau C, Lemiere C, Berbiche D, Perreault S, Blais L. Persistence, adherence, and effectiveness of combination therapy among adult patients with asthma. J Allergy Clin Immunol. 2006;118(3):574–581. doi:10.1016/j.jaci.2006.06.034.
  • Atectura® Breezhaler®. Summary of product characteristics (SmPC). 2021. Available from: https://www.medicines.org.uk/emc/product/11885/smpc. [last accessed 21 Aug 2021].
  • Enerzair® Breezhaler®. Summary of product characteristics (SmPC). 2021. Available from: https://www.medicines.org.uk/emc/product/11886/smpc. [last accessed 21 Aug 2021].
  • Brittain D, D’Andrea P, Gruen E, Hosoe M, Jain D, Jauernig J, Pethe A, Scosyrev E, Tanase A-M, Tillmann H-C, et al. A review of the unique drug development strategy of indacaterol acetate/glycopyrronium bromide/mometasone furoate: a first-in-class, once-daily, single-inhaler, fixed-dose combination treatment for asthma. Adv Ther. 2022; doi:10.1007/s12325-021-02025-w.
  • Onbrez® Breezhaler®. Summary of product characteristics (SmPC). 2021. Available from: https://www.medicines.org.uk/emc/product/7794/smpc. [last accessed 21 Aug 2021].
  • Seebri® Breezhaler® Summary of product characteristics (SmPC). 2021. Available from: https://www.medicines.org.uk/emc/product/2840. [last accessed 21 Aug 2021].
  • Asmanex® Twisthaler® 2021. Summary of product characteristics (SmPC). 2021. Available from: https://www.medicines.org.uk/emc/product/6753/smpc. [last accessed 21 Aug 2021].
  • Vaidya S, Ziegler D, Tanase A-M, Malmqvist U, Kanniess F, Hederer B, Hosoe M. Pharmacokinetics of mometasone furoate delivered via two dry powder inhalers. Pulm Pharmacol Ther. 2021;70:102019. doi:10.1016/j.pupt.2021.102019.
  • Buhl R, Kerstjens H, Nikolaev I, Vaidya S, Bartels C, Jain M, Jauernig J, Kottakis I, Qian C, Tillman H-C, et al. Corresponding doses of mometasone furoate (MF) in once-daily inhaled fixed-dose combination (FDC) of indacaterol/mometasone furoate (IND/MF) and indacaterol/glycopyrronium/mometasone furoate (IND/GLY/MF): results from randomized clinical studies. J Aller Clin Immunol. 2021;147(2):AB59. doi:10.1016/j.jaci.2020.12.235.
  • Kerstjens H, Maspero J, Chapman K, van Zyl-Smit R, Hosoe M, Tanase A-M, Lavecchia C, Pethe A, Shu X, D’Andrea P, et al. Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study. Lancet Respir Med. 2020;8(10):1000–1012. doi:10.1016/S2213-2600(20)30190-9.
  • van Zyl-Smit R, Krüll M, Gessner C, Gon Y, Noga O, Richard A, de los Reyes A, Shu X, Pethe A, Tanase A-M, et al. Once-daily mometasone plus indacaterol versus mometasone or twice-daily fluticasone plus salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled phase 3 study. Lancet Respir Med. 2020;8(10):987–999. doi:10.1016/S2213-2600(20)30178-8.
  • Global strategy for asthma management and prevention. 2016. Available from: https://ginasthma.org/. [last accessed 24 Sep 2016].
  • Scosyrev E, van Zyl-Smit R, Kerstjens H, Gessner C, Kornmann O, Jain D, Aubrun E, D’Andrea P, Hosoe M, Pethe A, et al. Cardiovascular safety of mometasone/indacaterol and mometasone/indacaterol/glycopyrronium once-daily fixed-dose combinations in asthma: pooled analysis of phase 3 trials. Respir Med. 2021;180:106311. doi:10.1016/j.rmed.2021.106311.
  • Gessner C, Kornmann O, Maspero J, van Zyl-Smit R, Krüll M, Salina A, Gupta P, Bostel S, Fucile S, Conde LG, et al. Fixed-dose combination of indacaterol/glycopyrronium/mometasone furoate once-daily versus salmeterol/fluticasone twice-daily plus tiotropium once-daily in patients with uncontrolled asthma: A randomised, Phase IIIb, non-inferiority study (ARGON). Respir Med. 2020;170:106021. doi:10.1016/j.rmed.2020.106021.
  • Kornmann O, Mucsi J, Kolosa N, Bandelli L, Sen B, Satlin L, D’Andrea P. Efficacy and safety of inhaled once-daily low-dose indacaterol acetate/mometasone furoate in patients with inadequately controlled asthma: Phase III randomised QUARTZ study findings. Respir Med. 2020;161:105809. doi:10.1016/j.rmed.2019.105809.

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