Efficacy and safety of once-daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol in Japanese patients with inadequately controlled asthma: the CAPTAIN study

References

• Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention; 2020 [cited 2020 Sep 15]. https://ginasthma.org/wp-content/uploads/2020/04/GINA-2020-full-report_-final-_wms.pdf.
   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(9):691–706.
   PubMed Web of Science ®Google Scholar
• Nakamura Y, Tamaoki J, Nagase H, et al. Japanese guidelines for adult asthma 2020. Allergol Int. 2020;69(4):519–548.
   Web of Science ®Google Scholar
• Bernstein DI, Bateman ED, Woodcock A, et al. Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma. J Asthma. 2015;52(10):1073–1083.
   PubMed Web of Science ®Google Scholar
• Davis J, Trudo F, Siddall J, et al. Burden of asthma among patients adherent to ICS/LABA: a real-world study. J Asthma. 2019;56(3):332–340.
   PubMed Web of Science ®Google Scholar
• Lee LK, Obi E, Paknis B, et al. Asthma control and disease burden in patients with asthma and allergic comorbidities. J Asthma. 2018;55(2):208–219.
   PubMed Web of Science ®Google Scholar
• Sulaiman I, Greene G, MacHale E, et al. A randomised clinical trial of feedback on inhaler adherence and technique in patients with severe uncontrolled asthma. Eur Respir J. 2018;51(1):1701126.
   PubMed Web of Science ®Google Scholar
• Adachi M, Hozawa S, Nishikawa M, et al. 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.
   PubMed Web of Science ®Google Scholar
• Nagase H, Adachi M, Matsunaga K, et al. Prevalence, disease burden, and treatment reality of patients with severe, uncontrolled asthma in Japan. Allergol Int. 2020;69(1):53–60.
   PubMed Web of Science ®Google Scholar
• Kerstjens HA, Engel M, Dahl R, et al. Tiotropium in asthma poorly controlled with standard combination therapy. N Engl J Med. 2012;367(13):1198–1207.
   PubMed Web of Science ®Google Scholar
• Kew KM, Dahri K. Long-acting muscarinic antagonists (LAMA) added to combination long-acting beta2-agonists and inhaled corticosteroids (LABA/ICS) versus LABA/ICS for adults with asthma. Cochrane Database Syst Rev. 2016;1:CD011721.
   Google Scholar
• Lee LA, Bailes Z, Barnes N, et al. Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial. Lancet Respir Med. 2021;9(1):69–84.
   PubMed Web of Science ®Google Scholar
• Allen A, Siederer S, Yang S. Population pharmacokinetics of inhaled fluticasone furoate and vilanterol in adult and adolescent patients with asthma. Int J Clin Pharmacol Ther. 2016;54(4):269–281.
   PubMed Web of Science ®Google Scholar
• Reddel HK, Taylor DR, Bateman ED, American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations, et al. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59–99.
   PubMed Web of Science ®Google Scholar
• Virchow JC, Backer V, de Blay F, et al. Defining moderate asthma exacerbations in clinical trials based on ATS/ERS joint statement. Respir Med. 2015;109(5):547–556.
   PubMed Web of Science ®Google Scholar
• Jones PW. St George's Respiratory Questionnaire: MCID. COPD. 2005;2(1):75–79.
   PubMedGoogle Scholar
• Juniper EF, Svensson K, Mörk AC, et al. Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med. 2005;99(5):553–558.
   PubMed Web of Science ®Google Scholar
• Tabberer M, von Maltzahn R, Bacci E, et al. Evaluation of the psychometric properties, scoring algorithm, and score interpretation of the E-RS: asthma in two clinical trials of moderate to severe asthma. Am J Respir Crit Care Med. 2020;201:A5624.
   Web of Science ®Google Scholar
• FDA. TRELEGY ELLIPTA prescribing information; 2020 [cited 2020 Oct 6]. www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Trelegy/pdf/TRELEGY-ELLIPTA-PI-PIL-IFU.PDF.
   Google Scholar
• Kerstjens HAM, Maspero J, Chapman KR, 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.
   PubMed Web of Science ®Google Scholar
• Virchow JC, Kuna P, Paggiaro P, et al. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised, controlled phase 3 trials. Lancet. 2019;394(10210):1737–1749.
   PubMed Web of Science ®Google Scholar
• Suzuki T, Fairburn-Beech J, Sato K, et al. Clinical characteristics, treatment patterns, disease burden, and persistence/adherence in patients with asthma initiating inhaled triple therapy: real-world evidence from Japan. Curr Med Res Opin. 2020;36(6):1049–1057.
   PubMed Web of Science ®Google Scholar
• Bateman ED, Esser D, Chirila C, et al. Magnitude of effect of asthma treatments on Asthma Quality of Life Questionnaire and Asthma Control Questionnaire scores: systematic review and network meta-analysis. J Allergy Clin Immunol. 2015;136(4):914–922.
   PubMed Web of Science ®Google Scholar
• Hozawa S, Ohbayashi H, Fowler A, et al. Long-term safety of once-daily single inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol in Japanese patients with asthma: a phase III open-label study. JSA/WOA Joint Congress; 2020 Sep 17–Oct 20.
   Google Scholar