197
Views
1
CrossRef citations to date
0
Altmetric
Study Protocol

The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease (COPD) in an Italian Context of Real Life: The TRITRIAL Study Protocol

, ORCID Icon, , &
Pages 159-166 | Published online: 27 Jan 2021

References

  • James GD, Donaldson GC, Wedzicha JA, Nazareth I. Trends in management and outcomes of COPD patients in primary care, 2000–2009: a retrospective cohort study. NPJ Prim Care Respir Med. 2014;24:14015. doi:10.1038/npjpcrm.2014.15
  • Vetrano DL, Zucchelli A, Bianchini E, et al. Triple inhaled therapy in COPD patients: determinants of prescription in primary care. Respir Med. 2019;154:12–17. doi:10.1016/j.rmed.2019.05.022
  • Singh D, Papi A, Corradi M, et al. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting β2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet. 2016;388(10048):963–973. doi:10.1016/S0140-6736(16)31354-X
  • 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(10082):1919–1929. doi:10.1016/S0140-6736(17)30188-5
  • 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 [published correction appears in Lancet. 2018 Feb 26]. Lancet. 2018;391(10125):1076–1084. doi:10.1016/S0140-6736(18)30206-X
  • Lipworth B, Manoharan A, Anderson W. Unlocking the quiet zone: the small airway asthma phenotype. Lancet Respir Med. 2014;2(6):497–506. doi:10.1016/S2213-2600(14)70103-1
  • Singh D, Vezzoli S, Petruzzelli S, Papi A. The efficacy of extrafine beclomethasone dipropionate-formoterol fumarate in COPD patients who are not “frequent exacerbators”: a post hoc analysis of the FORWARD study. Int J Chron Obstruct Pulmon Dis. 2017;12:3263–3271. doi:10.2147/COPD.S141416
  • Santus P, Radovanovic D, Pecchiari M, et al. The relevance of targeting treatment to small airways in asthma and COPD [published online ahead of print, 2020 Mar 24]. Respir Care. 2020;65(9):respcare.07237. doi:10.4187/respcare.07237
  • Scichilone N, Battaglia S, Sorino C, et al. Effects of extra-fine inhaled beclomethasone/formoterol on both large and small airways in asthma. Allergy. 2010;65(7):897–902. doi:10.1111/j.1398-9995.2009.02306.x
  • 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(26):2645–2653. doi:10.1056/NEJMoa032158
  • Hogg JC, Chu FS, Tan WC, et al. Survival after lung volume reduction in chronic obstructive pulmonary disease: insights from small airway pathology. Am J Respir Crit Care Med. 2007;176(5):454–459. doi:10.1164/rccm.200612-1772OC
  • Crisafulli E, Pisi R, Aiello M, et al. Prevalence of small-airway dysfunction among COPD patients with different GOLD stages and its role in the impact of disease. Respiration. 2017;93(1):32–41. doi:10.1159/000452479
  • Gupta N, Pinto LM, Morogan A, Bourbeau J. The COPD assessment test: a systematic review. Eur Respir J. 2014;44(4):873–884. doi:10.1183/09031936.00025214
  • Basile M, Baiamonte P, Mazzuca E, et al. Sleep disturbances in COPD are associated with heterogeneity of airway obstruction. COPD. 2018;15(4):350–354. doi:10.1080/15412555.2018.1504015
  • Pokrzywinski RF, Meads DM, McKenna SP, Glendenning GA, Revicki DA. Development and psychometric assessment of the COPD and asthma sleep impact scale (CASIS). Health Qual Life Outcomes. 2009;7:98. doi:10.1186/1477-7525-7-98
  • Lange P, Marott JL, Vestbo J, Nordestgaard BG. Prevalence of night-time dyspnoea in COPD and its implications for prognosis. Eur Respir J. 2014;43(6):1590–1598. doi:10.1183/09031936.00196713
  • Melani AS, Paleari D. Maintaining control of chronic obstructive airway disease: adherence to inhaled therapy and risks and benefits of switching devices. COPD. 2016;13(2):241–250. doi:10.3109/15412555.2015.1045972
  • Adherence to long-term therapies: evidence for action. World Health Organization; 2003. Available from: https://www.who.int/chp/knowledge/publications/adherence_full_report.pdf?ua=1. Accessed June 2020.
  • Plaza V, López-Viña A, Entrenas LM, et al. Differences in adherence and non-adherence behaviour patterns to inhaler devices between COPD and asthma patients. COPD. 2016;13(5):547–554. doi:10.3109/15412555.2015.1118449
  • Zucchelli A, Vetrano DL, Bianchini E, et al. Adherence to COPD free triple inhaled therapy in the real-world: a primary care based study [published online ahead of print, 2020 Mar 26]. Clin Respir J. 2020. doi:10.1111/crj.13190
  • Singh D, Agusti A, Anzueto A, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease: the GOLD science committee report 2019. Eur Respir J. 2019;53(5):1900164. doi:10.1183/13993003.00164-2019
  • Nolan CM, Longworth L, Lord J, et al. The EQ-5D-5L health status questionnaire in COPD: validity, responsiveness and minimum important difference. Thorax. 2016;71(6):493–500. doi:10.1136/thoraxjnl-2015-207782
  • Kon SS, Canavan JL, Jones SE, et al. Minimum clinically important difference for the COPD assessment test: a prospective analysis. Lancet Respir Med. 2014;2(3):195–203. doi:10.1016/S2213-2600(14)70001-3
  • Bosnic-Anticevich S, Chrystyn H, Costello RW, et al. The use of multiple respiratory inhalers requiring different inhalation techniques has an adverse effect on COPD outcomes [published correction appears in Int J Chron Obstruct Pulmon Dis. 2019 Aug 02;14:1739]. Int J Chron Obstruct Pulmon Dis. 2016;12:59–71. doi:10.2147/COPD.S117196
  • Yu AP, Guerin A, de Leon LP, et al. Clinical and economic outcomes of multiple versus single long-acting inhalers in COPD. Respir Med. 2011;105(12):1861–1871. doi:10.1016/j.rmed.2011.07.001
  • Chrystyn H, Small M, Milligan G, Higgins V, Gil EG, Estruch J. Impact of patients’ satisfaction with their inhalers on treatment compliance and health status in COPD. Respir Med. 2014;108(2):358–365. doi:10.1016/j.rmed.2013.09.021
  • Singh D. Single inhaler triple therapy with extrafine beclomethasone, formoterol, and glycopyrronium for the treatment of chronic obstructive pulmonary disease. Expert Opin Pharmacother. 2018;19(11):1279–1287. doi:10.1080/14656566.2018.1498841