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ORIGINAL RESEARCH

Effectiveness of Extrafine Single Inhaler Triple Therapy in Chronic Obstructive Pulmonary Disease (COPD) in Germany – The TriOptimize Study

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Pages 3019-3031 | Received 28 Jul 2022, Accepted 24 Nov 2022, Published online: 02 Dec 2022

References

  • Brusselle G, Price D, Gruffydd-Jones K, et al. The inevitable drift to triple therapy in COPD: an analysis of prescribing pathways in the UK. Int J Chron Obstruct Pulmon Dis. 2015;10:2207–2217. doi:10.2147/COPD.S91694
  • Martinez FJ, Rabe KF, Ferguson GT, et al. Reduced all-cause mortality in the ETHOS trial of budesonide/glycopyrrolate/formoterol for chronic obstructive pulmonary disease. A randomized, double-blind, multicenter, parallel-group study. Am J Respir Crit Care Med. 2021;203(5):553–564. doi:10.1164/rccm.202006-2618OC
  • Lipson DA, Crim C, Criner GJ, et al. Reduction in all-cause mortality with fluticasone furoate/umeclidinium/vilanterol in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2020;201(12):1508–1516. doi:10.1164/rccm.201911-2207OC
  • Andreas S, Taube C. Inhaled therapy reduces COPD mortality. ERJ Open Res. 2020;6:4. doi:10.1183/23120541.00634-2020
  • Vogelmeier C, Buhl R, Burghuber O, et al. Leitlinie zur Diagnostik und Therapie von Patienten mit chronisch obstruktiver Bronchitis und Lungenemphysem (COPD). Pneumologie. 2018;72(4):253–308. doi:10.1055/s-0043-125031
  • Mäkelä MJ, Backer V, Hedegaard M, Larsson K. Adherence to inhaled therapies, health outcomes and costs in patients with asthma and COPD. Respir Med. 2013;107(10):1481–1490. doi:10.1016/j.rmed.2013.04.005
  • Moreira, ATA, Pinto, CR, Lemos ACM, Assunção-Costa L, Souza GS, Martins Netto, E. Evidence of the association between adherence to treatment and mortality among patients with COPD monitored at a public disease management program in Brazil. J Bras Pneumol. 2022;e20210120. doi:10.36416/1806-3756/e20210120
  • Restrepo RD, Alvarez MT, Wittnebel LD, et al. Medication adherence issues in patients treated for COPD. Int J Chron Obstruct Pulmon Dis. 2008;3(3):371–384. doi:10.2147/copd.s3036
  • Bourbeau J, Bartlett SJ. Patient adherence in COPD. Thorax. 2008;63(9):831–838. doi:10.1136/thx.2007.086041
  • 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. Int J Chron Obstruct Pulmon Dis. 2017;12:59–71. doi:10.2147/COPD.S117196
  • Yu AP, Guérin A, Leon DP, 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
  • Usmani O, Roche N, Wahab E, et al. A scintigraphy study of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler in patients with moderate-to-very severe chronic obstructive pulmonary disease. Respir Res. 2021;22(1):261. doi:10.1186/s12931-021-01813-w
  • Usmani OS, Scichilone N, Mignot B, et al. Airway deposition of extrafine inhaled triple therapy in patients with COPD: a model approach based on functional respiratory imaging computer simulations. Int J Chron Obstruct Pulmon Dis. 2020;15:2433–2440. doi:10.2147/COPD.S269001
  • 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(10125):1076–1084. doi:10.1016/S0140-6736(18)30206-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
  • 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
  • Singh D, Schröder-Babo W, Cohuet G, et al. The bronchodilator effects of extrafine glycopyrronium added to combination treatment with beclometasone dipropionate plus formoterol in COPD: a randomised crossover study (the TRIDENT study). Respir Med. 2016;114:84–90. doi:10.1016/j.rmed.2016.03.018
  • Singh D, Corradi M, Spinola M, et al. Triple therapy in COPD: new evidence with the extrafine fixed combination of beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide. Int J Chron Obstruct Pulmon Dis. 2017;12:2917–2928. doi:10.2147/COPD.S146822
  • Fens T, Zhou G, Postma MJ, van Puijenbroek EP, van Boven JFM. Economic evaluations of chronic obstructive pulmonary disease pharmacotherapy: how well are the real-world issues of medication adherence, comorbidities and adverse drug-reactions addressed? Expert Opin Pharmacother. 2021;22(7):923–935. doi:10.1080/14656566.2021.1873953
  • Chew SY, Koh MS, Loo CM, Thumboo J, Shantakumar S, Matchar DB. Making clinical practice guidelines pragmatic: how big data and real world evidence can close the gap. Ann Acad Med Singap. 2018;47(12):523–527. doi:10.47102/annals-acadmedsg.V47N12p523
  • Tashkin DP, Amin AN, Kerwin EM. Comparing randomized controlled trials and real-world studies in chronic obstructive pulmonary disease pharmacotherapy. Int J Chron Obstruct Pulmon Dis. 2020;15:1225–1243. doi:10.2147/COPD.S244942
  • Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease; 2020. Available from: http://goldcopd.org/gold-. Accessed November 28, 2022.
  • Jones PW, Harding G, Berry P, Wiklund I, Chen W-H, Kline Leidy N. Development and first validation of the COPD assessment test. Eur Respir J. 2009;34(3):648–654. doi:10.1183/09031936.00102509
  • Devine J, Otto C, Rose M, et al. A new computerized adaptive test advancing the measurement of health-related quality of life (HRQoL) in children: the Kids-CAT. Qual Life Res. 2015;24(4):871–884. doi:10.1007/s11136-014-0812-7
  • Plaza V, Fernández-Rodríguez C, Melero C, et al. Validation of the ‘Test of the Adherence to Inhalers’ (TAI) for Asthma and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2016;29(2):142–152. doi:10.1089/jamp.2015.1212
  • Quanjer PH, Stanojevic S, Cole TJ, et al. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012;40(6):1324–1343. doi:10.1183/09031936.00080312
  • Koch B, Friedrich N, Völzke H, et al. Static lung volumes and airway resistance reference values in healthy adults. Respirology. 2013;18(1):170–178. doi:10.1111/j.1440-1843.2012.02268.x
  • Lopez-Campos JL, Carrasco-Hernandez L, Quintana-Gallego E, et al. Triple therapy for COPD: a crude analysis from a systematic review of the evidence. Available from: 10.1177/1753466619885522. Accessed December 17, 2021.
  • 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 trial. Lancet Respir Med. 2018;6(10):747–758. doi:10.1016/S2213-2600(18)30327-8
  • Halpin DMG, Worsley S, Ismaila AS, et al. INTREPID: single- versus multiple-inhaler triple therapy for COPD in usual clinical practice. ERJ Open Res. 2021;7:2. doi:10.1183/23120541.00950-2020
  • Marth K, Renner A, Pohl W. TRICOP - A Real-world effectiveness study with a single-inhaler extrafine triple therapy over 52 weeks in Austrian patients with COPD. Respir Med. 2021;182:106398. doi:10.1016/j.rmed.2021.106398
  • Cazzola M, Celli B. Triple therapy is also effective in real-world when used in chronic obstructive pulmonary disease patients who are frequent exacerbators. Respiration. 2021;100(2):93–95. doi:10.1159/000512728
  • Cheng W, Duan J, Zhou A, et al. Real-world effectiveness of inhalation therapy among patients with symptomatic COPD in China: a multicenter prospective study. Front Pharmacol. 2021;12:753653. doi:10.3389/fphar.2021.753653
  • Richeldi L, Piraino A, Macagno F, Micarelli G, Ingrassia E. 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. Int J Chron Obstruct Pulmon Dis. 2021;16:159–166. doi:10.2147/COPD.S286559
  • Voorham J, Corradi M, Papi A, et al. Comparative effectiveness of triple therapy versus dual bronchodilation in COPD. ERJ Open Res. 2019;5:3. doi:10.1183/23120541.00106-2019
  • von Siemens SM, Alter P, Lutter JI, et al. CAT score single item analysis in patients with COPD: results from COSYCONET. Respir Med. 2019;159:105810. doi:10.1016/j.rmed.2019.105810
  • Worth H, Buhl R, Criée C-P, Kardos P, Mailänder C, Vogelmeier C. The ‘real-life’ COPD patient in Germany: the DACCORD study. Respir Med. 2016;111:64–71. doi:10.1016/j.rmed.2015.12.010
  • Mueller S, Gottschalk F, Groth A, et al. Primary data, claims data, and linked data in observational research: the case of COPD in Germany. Respir Res. 2018;19(1):161. doi:10.1186/s12931-018-0865-1
  • Kon SSC, 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
  • Criée CP, Sorichter S, Smith HJ, et al. Body plethysmography – its principles and clinical use. Respir Med. 2011;105(7):959–971. doi:10.1016/j.rmed.2011.02.006
  • Donohue JF. Minimal clinically important differences in COPD lung function. COPD. 2005;2(1):111–124. doi:10.1081/copd-200053377
  • Jo YS, Kim SK, Park SJ, et al. Longitudinal change of FEV1 and inspiratory capacity: clinical implication and relevance to exacerbation risk in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2019;14:361–369. doi:10.2147/COPD.S189384
  • Pasquale CB, Choate R, McCreary G, et al. Self-reported COPD medication use and adherence in the COPD foundation patient- powered registry network. Chronic Obstr Pulm Dis. 2021;8(4):474–487. doi:10.15326/jcopdf.2021.0252
  • Duarte-de-Araújo A, Teixeira P, Figueiredo M, Hespanhol V, Correia-de-Sousa J. Understanding patient adherence to inhaled medication: the social representations of COPD. Rev Port Pneumol. 2017;23(6):358–359. doi:10.1016/j.rppnen.2017.07.008
  • Zucchelli A, Vetrano DL, Bianchini E, et al. Adherence to COPD free triple inhaled therapy in the real world: a primary care based study. Clin Respir J. 2020;14:732–739. doi:10.1111/crj.13190
  • Lareau SC, Yawn BP. Improving adherence with inhaler therapy in COPD. Int J Chron Obstruct Pulmon Dis. 2010;5:401–406. doi:10.2147/COPD.S14715
  • Hall GL, Filipow N, Ruppel G, et al. Official ERS technical standard: global Lung Function Initiative reference values for static lung volumes in individuals of European ancestry. Eur Respir J. 2021;57:3. doi:10.1183/13993003.00289-2020