An Italian Delphi Consensus on the Triple inhalation Therapy in Chronic Obstructive Pulmonary Disease

An Italian Delphi Consensus on the Triple inhalation Therapy in Chronic Obstructive Pulmonary Disease

Authors

  • Paolo Solidoro University of Turin, Medical Sciences Department, Pneumology Unit U, Cardiovascular and Thoracic Department, AOU Città Della Salute e Della Scienza di Torino, Italy
  • Federico Dente Respiratory Pathophysiology Unit, Department of Surgery, Medicine, Molecular Biology, and Critical Care, University of Pisa, Pisa, Italy
  • Claudio Micheletto Pneumology Unit, Cardio-Thoracic Department, Azienda Ospedaliera Universitaria Integrata, Verona, Italy
  • Giovanni Pappagallo School of Clinical Methodology, IRCCS “Sacre Heart - Don Calabria”, Negrar di Valpolicella, Italy
  • Girolamo Pelaia Department of Health Sciences, University “Magna Græcia” of Catanzaro, Catanzaro, Italy
  • Alberto Papi Respiratory Medicine Unit, University of Ferrara, Ferrara, Italy

Keywords:

chronic obstructive disease, Delphi process, triple combination therapy, long-acting beta2-agonist, long-acting muscarinic receptor antagonist, inhaled corticosteroid

Abstract

Background: The management of chronic obstructive pulmonary disease (COPD) lacks standardization due to the diverse clinical presentation, comorbidities, and limited acceptance of recommended approaches by physicians. To address this, a multicenter study was conducted among Italian respiratory physicians to assess consensus on COPD management and pharmacological treatment.
Methods: The study employed the Delphi process using the Estimate-Talk-Estimate method, involving a scientific board and expert panel. During a 6-month period, the scientific board conducted the first Delphi round and identified 11 broad areas of COPD management to be evaluated while the second Delphi round translated all 11 items into statements. The statements were subsequently presented to the expert panel for independent rating on a nine-point scale. Consensus was considered achieved if the median score was 7 or higher. Consistently high levels of consensus were observed in the first rating, allowing the scientific board to finalize the statements without requiring further rounds.
Results: Topics generating substantial discussion included the pre-COPD phase, patient-reported outcomes, direct escalation from a single bronchodilator to triple therapy, and the role of adverse events, particularly pneumonia, in guiding triple therapy prescriptions. Notably, these topics exhibited higher standard deviations, indicating greater variation in expert opinions.
Conclusions: The study emphasized the significance that Italian pulmonologists attribute to managing mortality, tailoring treatments, and addressing cardiovascular comorbidities in COPD patients. While unanimous consensus was not achieved for all statements, the results provide valuable insights to inform clinical decision-making among physicians and contribute to a better understanding of COPD management practices in Italy.

References

2023 GOLD Report [Internet]. Global Initiative for Chronic Obstructive Lung Disease - GOLD. [cited 2022 Dec 6]. Available from: https://goldcopd.org/2023-gold-report-2/

WHO. Chronic obstructive pulmonary disease (COPD) [Internet]. [cited 2023 Jun 12]. Available from: https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)

WHO Global Health Estimates. The top 10 causes of death. 2020 [cited july 2022]. Available from: https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death

Dati ISTAT 2022. Available from: http://dati.istat.it/#

Diab N, Gershon AS, Sin DD, Tan WA, Bourbeau J, -Boulet LP, et al. Underdiagnosis and Overdiagnosis of Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med 2018;198:1130-9.

Calabria S, Ronconi G, Dondi L, Pedrini A, Piccinni C, Esposito I, et al. Real-World Analysis of Obstructive Respiratory Tract Disorders: Characterization, Health Care and Costs. Recenti Prog Med 2021;112:285-93.

Ronconi G, Dondi L, Pedrini A, Calabria S, Piccinni C, Capponcelli A, et al. PRS45 Obstructive Airway Diseases: Real Clinical Practice from the Large Italian Administrative Database of Fondazione Ricerca E Salute (RES). Value in Health 2020;23:S725.

Halpin DMG, Decramer M, Celli B, Kesten S, Liu D, Tashkin DP. Exacerbation Frequency and Course of COPD. Int J Chron Obstruct Pulmon Dis 2012;7:653-61.

Donaldson GC, Wilkinson TMA, Hurst JR, Perera WR, Wedzicha JA. Exacerbations and Time Spent Outdoors in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med 2005;171:446-52.

Soler-Cataluña JJ, Martínez-García MA, Román Sánchez P, Salcedo E, Navarro M, Ochando R. Severe Acute Exacerbations and Mortality in Patients with Chronic Obstructive Pulmonary Disease. Thorax 2005;60:925-31.

Patel NK, Shah SJ, Lee NK, Gao Q, Carullo VP, Yang CJ. Intraoperative Intravenous Ibuprofen Use is not Associated with Increased Post-tonsillectomy Bleeding. Int J Pediatr Otorhinolaryngol 2020;133:109965.

Dransfield MT, Criner GJ, Halpin DMG, Han MK, Hartley B, Kalhan R, et al. Time-Dependent Risk of Cardiovascular Events Following an Exacerbation in Patients with Chronic Obstructive Pulmonary Disease: Post Hoc Analysis from the IMPACT Trial. J Am Heart Assoc 2022;11:e024350.

Halpin DMG, Miravitlles M, Metzdorf N, Celli B. Impact and Prevention of Severe Exacerbations of COPD: A Review of the Evidence. Int J Chron Obstruct Pulmon Dis 2017;12:2891-908.

Müllerová H, Shukla A, Hawkins A, Quint J. Risk Factors for Acute Exacerbations of COPD in a Primary Care Population: A Retrospective Observational Cohort Study. BMJ Open 2014;4:e006171.

Solem CT, Sun SX, Sudharshan L, Macahilig C, Katyal M, Gao X. Exacerbation-related Impairment of Quality of Life and Work Productivity in Severe and Very Severe Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis 2013;8:641-52.

Lipson DA, Barnhart F, Brealey N, Brooks J, Criner GJ, Day NC, et al. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. N Engl J Med 2018;378:1671-80.

Lipson DA, Barnacle H, Birk R, Brealey N, Locantore N, Lomas DA, et al. FULFIL Trial: Once-Daily Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med 2017;196:438-46.

Papi A, Vestbo J, Fabbri L, Corradi M, Prunier H, Cohuet G, 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;391:1076-84.

Singh D. Single Inhaler Triple Therapy with Extrafine -Beclomethasone, Formoterol, and Glycopyrronium for the Treatment of Chronic Obstructive Pulmonary Disease. Expert Opin Pharmacother 2018;19:1279-87.

Vestbo J, Lange P. Can GOLD Stage 0 Provide Information of Prognostic Value in Chronic Obstructive Pulmonary Disease? Am J Respir Crit Care Med 2002;166:329-32.

Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, et al. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med 2020;383:35-48.

Lipson DA, Crim C, Criner GJ, Day NC, Dransfield MT, Halpin DMG, 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;201:1508-16.

Martinez FJ, Rabe KF, Ferguson GT, Wedzicha JA, Singh D, Wang C, 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;203:553-64.

Gustafson DH, Shukla RK, Delbecq A, Walster GW. A Comparative Study of Differences in Subjective Likelihood Estimates Made by Individuals, Interacting Groups, Delphi Groups, and Nominal Groups. Organizational Behavior and Human Performance 1973;9:280-91. https://doi.org/10.1016/0030-5073(73)90052-4

Rowe G, Wright G. Expert Opinions in Forecasting: The Role of the Delphi Technique. In: J. Armstrong (Ed.) Principles of Forecasting 2001:125-144. Boston: Kluwer Academic

Jones J, Hunter D. Consensus Methods for Medical and Health Services Research. BMJ 1995;311:376-80.

Kaplan MF. The Influencing Process in Group Decision Making. In: Hendrick C. (Ed.), Group Processes 1987; 189-212. Sage Publications, Inc.

Fitch K, Bernstein SJ, Aguilar MD, Nurnand B, LaCalle JR, Lazaro P, et al. The Rand/UCLA Appropriateness Method User’s Manual. Rand; 2001.

Pauwels RA, Buist AS, Calverley PM, Jenkins CR, Hurd SS, GOLD Scientific Committee. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med 2001;163:1256-76.

Cosío BG, Casanova C, Soler-Cataluña JJ, Soriano JB, García-Río F, de Lucas P, et al. Unravelling Young COPD and Pre-COPD in the General Population. ERJ Open Res 2023;9:00334-2022.

Woodruff PG, Barr RG, Bleecker E, Christenson SA, Couper D, Curtis JL, et al. Clinical Significance of Symptoms in Smokers with Preserved Pulmonary Function. N Engl J Med 2016;374:1811-21.

Vestbo J, Papi A, Corradi M, Blazhko V, Montagna I, Francisco C, 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;389:1919-29.

Martinez FJ, Han MK, Allinson JP, Barr RG, Boucher RC, Calverley PMA, et al. At the Root: Defining and Halting Progression of Early Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med 2018;197:1540-51.

Young KA, Strand MJ, Ragland MF, Kinney GL, Austin EE, Regan EA, et al. Pulmonary Subtypes Exhibit Differential Global Initiative for Chronic Obstructive Lung Disease Spirometry Stage Progression: The COPDGene® study. Chronic Obstr Pulm Dis 2019;6:414-29.

Brusasco V, Pellegrino R, Rodarte JR. Vital Capacities in Acute and Chronic Airway Obstruction: Dependence on Flow and Volume Histories. Eur Respir J 1997;10:1316-20.

Berton DC, Neder JA. Measuring Slow Vital Capacity to Detect Airflow Limitation in a Woman with Dyspnea and a Preserved FEV1/FVC Ratio. J Bras Pneumol 2019;45:e20190084.

Pedersen OF, Butler JP. Expiratory Flow Limitation. Compr Physiol 2011;1:1861-82.

Jones PW, Brusselle G, Dal Negro RW, Ferrer M, Kardos P, Levy ML, et al. Health-Related Quality of Life in Patients by COPD Severity Within Primary Care in europe. Respir Med 2011;105:57-66.

Buist AS, Mcburnie MA, Vollmer WM, Gillespie S, Burney P, Mannino DM, et al. International Variation in the Prevalence of COPD (The BOLD Study): A Population-Based Prevalence Study. Lancet 2007;370:741-50.

US Department of Health and Human Services Food and Drug Administration. Guidance for Industry: Patient--Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims; 2009 [cited July 2022]. Available from: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf.

Gross NJ. Extrapulmonary Effects of Chronic Obstructive Pulmonary Disease. Curr Opin Pulm Med 2001;7:84-92.

Vanfleteren LEGW, Spruit MA, Groenen M, Gaffron S, van Empel VPM, Bruijnzeel PLB, et al. Clusters of Comorbidities Based on Validated Objective Measurements and Systemic Inflammation in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med 2013;187:728-35.

Brennan M, McDonnell MJ, Harrison MJ, Duignan N, O’Regan A, Murphy DM, et al. Antimicrobial Therapies for Prevention of Recurrent Acute Exacerbations of COPD (AECOPD): Beyond the Guidelines. Respir Res 2022;23:58.

Pavord ID, Jones PW, Burgel PR, Rabe KF. Exacerbations of COPD. Int J Chron Obstruct Pulmon Dis 2016;11(Spec Iss):21-30.

Viniol C, Vogelmeier CF. Exacerbations of COPD. Eur Respir Rev 2018;27:170103.

Canepa M, Temporelli PL, Rossi A, Rossi A, Gonzini L, Nicolosi GL, et al. Prevalence and Prognostic Impact of Chronic Obstructive Pulmonary Disease in Patients with Chronic Heart Failure: Data from the GISSI-HF Trial. Cardiology (Switzerland). Cardiology 2017;136:128-37.

Hawkins NM. Chronic Obstructive Pulmonary Disease and Heart Failure in Europe - Further Evidence of the Need for Integrated Care. Eur J Heart Fail 2018;20:111-13.

Axson EL, Sundaram V, Bloom CI, Bottle A, Cowie MR, Quint JK. Temporal Trends in the Incidence of Heart Failure among Patients with Chronic Obstructive Pulmonary Disease and Its Association with Mortality. Ann Am Thorac Soc 2020;17:939-48.

Kaszuba E, Odeberg H, Råstam L, Halling A. Impact of Heart Failure and Other Comorbidities on Mortality in Patients with Chronic Obstructive Pulmonary Disease: A Register-Based, Prospective Cohort Study. BMC Fam Pract 2018;19:178.

Zhang L, Liu Y, Zhao S, Wang Z, Zhang M, Zhang S, et al. The Incidence and Prevalence of Pulmonary Hypertension in the COPD Population: A Systematic Review and Meta-Analysis. Int J Chron Obstruct Pulmon Dis 2022;17:1365-79.

Kovacs G, Avian A, Bachmaier G, Troester N, Tornyos A, Douschan P, et al. Severe Pulmonary Hypertension in COPD: Impact on Survival and Diagnostic Approach. Chest 2022;162:202-12.

Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural History of Chronic Obstructive Pulmonary Disease Exacerbations in a General Practice-Based Population with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med 2018;198:464-71.

Wang M, Lin EPY, Huang LC, Li CY, Shyr Y, Lai CH. Mortality of Cardiovascular Events in Patients With COPD and Preceding Hospitalization for Acute Exacerbation. Chest 2020;158:973-85.

Whittaker H, Rubino A, Müllerová H, Morris T, Varghese P, Xu Y, et al. Frequency and Severity of Exacerbations of COPD Associated with Future Risk of Exacerbations and Mortality: A UK Routine Health Care Data Study. Int J Chron Obstruct Pulmon Dis 2022;17:427-37.

Halpin DMG, Martinez FJ. Pharmacotherapy and Mortality in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med 2022;206:1201-7.

Calverley PMA, Anderson JA, Celli B, Ferguson GT, -Jenkins C, Jones PW, et al. Salmeterol and Fluticasone Propionate and Survival in Chronic Obstructive -Pulmonary Disease. N Engl J Med 2007;356:775-89.

Wise RA, Anzueto A, Cotton D, Dahl R, Devins T, Disse B, et al. Tiotropium Respimat Inhaler and the Risk of Death in COPD. N Engl J Med 2013;369:1491-501.

Vestbo J, Anderson JA, Brook RD, Calverley PMA, Celli BR, Coutney C, et al. Fluticasone Furoate and Vilanterol and Survival in Chronic Obstructive Pulmonary Disease with Heightened Cardiovascular Risk (SUMMIT): A Double-Blind Randomised Controlled Trial. Lancet 2016;387:1817-26.

Fishman A, Martinez F, Naunheim K, Piantadosi S, Wise R, Ries A, et al. A Randomized Trial Comparing Lung--Volume-Reduction Surgery with Medical Therapy for -Severe Emphysema. N Engl J Med 2003;348:2059-73.

Long Term Domiciliary Oxygen Therapy in Chronic Hypoxic Cor Pulmonale Complicating Chronic Cronchitis and Emphysema. Report of the Medical Research Council Working Party. Lancet 1981;1:681-6.

Continuous or Nocturnal Oxygen Therapy in Hypoxemic Chronic Obstructive Lung Disease A Clinical Trial Nocturnal Oxygen Therapy Trial group. Ann Intern Med 1980;93:391-8.

Chen H, Deng ZX, Sun J, Huang Q, Huang L, He YH, et al. Association of Inhaled Corticosteroids With All-Cause Mortality Risk in Patients With COPD: A Meta-analysis of 60 Randomized Controlled Trials. Chest 2023;163:100-14.

Chen H, Sun J, Huang Q, Liu Y, Yuan M, Ma C, et al. -Inhaled Corticosteroids and the Pneumonia Risk in Patients With Chronic Obstructive Pulmonary Disease: A Meta-analysis of Randomized Controlled Trials. Front Pharmacol 2021;12:691621.

Sin DD, Tashkin D, Zhang X, Radner F, Sjöbring U, Thorén A, et al. Budesonide and the Risk of Pneumonia: A Meta-Analysis of Individual Patient Data. Lancet 2009;374:712-9.

Zhang Q, Li S, Zhou W, Yang X, Li J, Cao J. Risk of Pneumonia with Different Inhaled Corticosteroids in COPD Patients: A Meta-Analysis. COPD 2020;17:462-9.

Alcázar-Navarrete B, Jamart L, Sánchez-Covisa J, Juárez M, Graefenhain R, Sicras-Mainar A. Clinical Characteristics, Treatment Persistence, and Outcomes Among Patients With COPD Treated With Single- or Multiple-Inhaler Triple Therapy: A Retrospective Analysis in Spain. Chest 2022;162:1017-29.

Meynell H, Capstick T. Role of Dual and Triple Fixed-Dose Combination Inhalers in the Treatment of Chronic Obstructive Pulmonary Disease. The Pharmaceutical Journal, 2018. Available from: https://pharmaceutical-journal.com/article/research/role-of-dual-and-triple-fixed--dose-combination-inhalers-in-the-treatment-of-chronic-obstructive-pulmonary-disease.

Zhang S, King D, Rosen VM, Ismaila AS. Impact of -Single Combination Inhaler versus Multiple Inhalers to Deliver the Same Medications for Patients with Asthma or COPD: A Systematic Literature Review. Int J Chron Obstruct Pulmon Dis 2020;15:417-38.

Bogart M, Wu B, Germain G, Laliberté F, MacKnight S,

Jung Y, et al. Real World Adherence to Single-Inhaler vs Multiple-Inhaler Triple Therapy Among Patients with COPD in a Commercially Insured us Population. Chest 2020;158:A1773-A74.

Contoli M, Morandi L, Di Marco F, Carone M. A Perspective for Chronic Obstructive Pulmonary Disease (COPD) Management: Six Key Clinical Questions to Improve Disease Treatment. Expert Opin Pharmacother 2021;22:427-37.

Pauwels RA, Buist AS, Calverly PM, Jenkins CR, Hurd SS, Gold Scientific Committee. Global Strategy for the Diagnosis, Management, and the Prevention of Chronic Obstructive Pulmonary Disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary.Am J Respir Crit Care Med 2001;163:1256-76.

Bafadhel M, Rabe KF, Martinez FJ, Singh D, Darken P, Jenkins M, et al. Benefits of Budesonide/-Glycopyrronium/ Formoterol Fumarate Dihydrate on COPD Exacerbations, Lung Function, Symptoms, and Quality of Life Across Blood Eosinophil Ranges: A Post-Hoc Analysis of Data from ETHOS. Int J Chron Obstruct Pulmon Dis 2022;17:3061-73.

Ferguson GT, Rabe KF, Martinez FJ, Fabbri LM, Wang C, Ichinose M, 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;6:747-58.

Lee JH, Lee YK, Kim EK, Kim TH, Huh JW, Lim QJ, et al. Responses to Inhaled Long-Acting Beta-Agonist and Corticosteroid According to COPD Subtype. Respir Med 2010;104:542-9.

Bakeer M, Funk GC, Valipour A. Chronic Obstructive Pulmonary Disease Phenotypes: Imprint on Pharmacological and Non-Pharmacological Therapy. Ann Transl Med 2020;8:1472.

Hogg JC, Macklem PT, Thurlbeck WM. Site and Nature of Airway Obstruction in Chronic Obstructive Lung Disease. N Engl J Med 1968;278:1355-60.

Stockley JA, Cooper BG, Stockley RA, Sapey E. Small Airways Disease: Time for a Revisit? Int J Chron Obstruct Pulmon Dis 2017;12:2343-53.

Burgel PR. The Role of Small Airways in Obstructive -Airway Diseases. Eur Respir Rev 2011;20:23-33.

Liptay MJ, Basu S, Hoaglin MC, Freedman N, Faber LP, Warren WH, et al. Diffusion Lung Capacity for Carbon Monoxide (DLCO) is an Independent Prognostic Factor for Long-Term Survival After Curative Lung Resection for Cancer. J Surg Oncol 2009;100:703-7.

Kim ES, Kim YT, Kang CH, Park IK, Bae W, Choi SM, et al. Prevalence of and Risk Factors for Postoperative Pulmonary Complications after Lung Cancer Surgery in Patients with Early-Stage. Int J Chron Obstruct Pulmon Dis 2016;11:1317-26.

Díaz AA, Pinto-Plata V, Hernández C, Peña J, Ramos C, Díaz JC, et al. Emphysema and DLCO Predict a Clinically Important Difference for 6MWD Decline in COPD. Respir Med 2015;109:882-9.

Grydeland TB, Thorsen E, Dirksen A, Jensen R, Coxson HO, Pillai SG, et al. Quantitative CT Measures of Emphysema and Airway Wall Thickness are Related to DLCO. Respir Med 2011;105:343-51.

Burke H, Wilkinson TMA. Unravelling the Mechanisms Driving Multimorbidity in COPD to Develop Holistic Approaches to Patient-Centred Care. Eur Respir Rev 2021;30:210041.

Mannino DM, Thorn D, Swensen A, Holguin F. Prevalence and Outcomes of Diabetes, Hypertension and Cardiovascular Disease in COPD. Eur Respir J 2008;32:962-9.

Williams NP, Coombs NA, Johnson MJ, Josephs LK, Rigge LA, Staples KJ, et al. Seasonality, Risk Factors and Burden of Community-Acquired Pneumonia in COPD Patients: A Population Database Study Using Linked Health Care Records. Int J Chron Obstruct Pulmon Dis 2017;12:313-22.

Foster TS, Miller JD, Marton JP, Caloyeras JP, Russell MW, Menzin J. Assessment of the Economic Burden of COPD in the U.S.: A Review and Synthesis of the Literature. COPD 2006;3:211-8.

Miller J, Edwards LD, Agustí A, Bakke P, Calverley PMA, Celli B, et al. Comorbidity, Systemic Inflammation and Outcomes in the ECLIPSE Cohort. Respir Med 2013;107:1376-84.

Sin DD, Anthonisen NR, Soriano JB, Agusti AG. Mortality in COPD: Role of Comorbidities. Eur Respir J 2006;28:1245-57.

Sin DD, Man JP, Man SFP. The risk of osteoporosis in Caucasian men and women with obstructive airways disease. Am J Med 2003;114:10-4.

Siris ES, Chen YT, Abbott TA, Barrett-Connor E, Miller PD, Wehren LE, et al. Bone Mineral Density Thresholds for Pharmacological Intervention to Prevent Fractures. Arch Intern Med 2004;164:1108-12.

García Rodríguez LA, Ruigómez A, Martín-Merino E, Johansson S, Wallander MA. Relationship Between Gastroesophageal Reflux Disease and COPD in UK Primary Care. Chest 2008;134:1223-30.

Seymour JM, Spruit MA, Hopkinson NS, Natanek SA, Man WD-C, Jackson A, et al. The Prevalence of Quadriceps Weakness in COPD and the Relationship with Disease Severity. Eur Respir J 2010;36:81-8.

Hanania NA, Müllerova H, Locantore NW, Vestbo J, -Watkins ML, Wouters EFM, et al. Determinants of Depression in the ECLIPSE Chronic Obstructive Pulmonary Disease Cohort. Am J Respir Crit Care Med 2011;183:604-11.

Sin DD, Paul Man SF. Why Are Patients With Chronic Obstructive Pulmonary Disease at Increased Risk of -Cardiovascular Diseases? The Potential Role of Systemic Inflammation in Chronic Obstructive Pulmonary Disease. Circulation 2003;107:1514-9.

Feary JR, Rodrigues LC, Smith CJ, Hubbard RB, Gibson JE. Prevalence of Major Comorbidities in Subjects with COPD and Incidence of Myocardial Infarction and Stroke: A Comprehensive Analysis Using Data from Primary Care. Thorax 2010;65:956-62.

Soriano JB, Visick GT, Muellerova H, Payvandi N, Hansell AL. Patterns of Comorbidities in Newly Diagnosed COPD and Asthma in Primary Care. Chest 2005;128:2099-107.

Hanson C, Rutten EP, Wouters EFM, Rennard S. Influence of Diet and Obesity on COPD Development and Outcomes. Int J Chron Obstruct Pulmon Dis 2014;9:723-33.

Solidoro P, Albera C, Ribolla F, Bellocchia M, Brussino L, Patrucco F. Triple Therapy in COPD: Can We Welcome the Reduction in Cardiovascular Risk and Mortality? Front Med (Lausanne). 2022;9:816843.

Müllerova H, Agusti A, Erqou S, Mapel DW. Cardiovascular Comorbidity in COPD: Systematic Literature -Review. Chest 2013;144:1163-78.

Curkendall SM, DeLuise C, Jones JK, Lanes S, Stang MR, Goehring E Jr, et al. Cardiovascular Disease in Patients with Chronic Obstructive Pulmonary Disease, Saskatchewan Canada: Cardiovascular Disease in COPD Patients. Ann Epidemiol 2006;16:63-70.

Yin HL, Yin SQ, Lin QY, Xu Y, Xu HW, Liu T. Prevalence of Comorbidities in Chronic Obstructive Pulmonary Disease Patients. Medicine (Baltimore) 2017;96:e6836.

Rabe KF, Hurst JR, Suissa S. Cardiovascular Disease and COPD: Dangerous Liaisons? Eur Respir Rev 2018;27:180057.

Axson EL, Ragutheeswaran K, Sundaram V, Bloom CI, Bottle A, Cowie MR, et al. Hospitalisation and Mortality in Patients with Comorbid COPD and Heart Failure: A Systematic Review and Meta-Analysis. Respir Res 2020;21:54.

Canepa M, Straburzynska-Migaj E, Drozdz J, Fernandez-Vivancos C, Pinilla JMG, Nyolczas N, et al. Characteristics, Treatments and 1-year Prognosis of Hospitalized and Ambulatory Heart Failure Patients with Chronic Obstructive Pulmonary Disease in the European Society of Cardiology Heart Failure Long-Term Registry. Eur J Heart Fail 2018;20:100-10.

Xu S, Ye Z, Ma J, Yuan T. The Impact of Chronic -Obstructive Pulmonary Disease on Hspitalization and Mortality in Patients with Heart Failure. Eur J Clin Invest 2021;51:e13402.

Marott JL, Ingebrigtsen TS, Colak Y, Vestbo J, Lange P. Trajectory of Preserved Ratio Impaired Spirometry: Natural History and Long-Term Prognosis. Am J Respir Crit Care Med 2021;204:910-20.

Higbee DH, Granell R, Davey Smith G, Dodd JW. Prevalence, Risk Factors, and Clinical Implications of Preserved Ratio Impaired Spirometry: a UK Biobank Cohort -Analysis. Lancet Respir Med 2022;10:149-57.

Wan ES, Balte P, Schwartz JE, Bhatt SP, Cassano PA, Couper D, et al. Association between Preserved Ratio Impaired Spirometry and Clinical Outcomes in US Adults. JAMA 2021;326:2287-98.

Krishnan S, Tan WC, Farias R, Aaron SD, Benedetti A, Chapman KR, et al. Impaired Spirometry and COPD Increase the Risk of Cardiovascular Disease: A Canadian Cohort Study. Chest 2023;164:637-49.

Calverley PMA, Magnussen H, Miravitlles M, Wedzicha JA. Triple Therapy in COPD: What We Know and What We Don’t. COPD 2017;14:648-62.

Mantero M, Radovanovic D, Santus P, Blasi F. Management of Severe COPD Exacerbations: Focus on Beclomethasone Dipropionate/Formoterol/Glycopyrronium Bromide. Int J Chron Obstruct Pulmon Dis 2018;13:2319-33.

Mcdonald CF, Bardin PG. High or Low Impact? -Triple Therapy in Chronic Obstructive Pulmonary Disease. Respirology 2018;23:891-2.

Montuschi P, Malerba M, Macis G, Mores N, Santini G. Triple Inhaled Therapy for Chronic Obstructive Pulmonary Disease. Drug Discov Today 2016;21:1820-7.

Singh D, Corradi M, Spinola M, Papi A, Usmani OS, Scuri 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;12:2917-28.

Schabert V, Shah S, Holmgren U, Cabrera C. Prescribing Pathways to Triple therapy in Patients with chronic obstructive pulmonary disease in the United States. Ther Adv Respir Dis 2021;15:1753466211001018.

Monteagudo M, Barrecheguren M, Solntseva I, Dhalwani N, Booth A, Nuñez A, et al. Clinical Characteristics and Factors Associated with Triple Therapy Use in Newly Diagnosed Patients with COPD. NPJ Prim Care Respir Med 2021;31:16.

Vanfleteren LEGW, Ullman A, Nordenson A, Andersson A, Andelid K, Fabbri LM. Triple Therapy (ICS/LABA/LAMA) in COPD: Thinking Out of the Box. ERJ Open Res 2019;5:00185-2018.

Lindenauer PK, Dharmarajan K, Qin L, Lin Z, Gershon AS, Krumholz HM. Risk Trajectories of Readmission and Death in the First Year After Hospitalization for Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med 2018;197:1009-17.

Bafadhel M, Pavord ID, Russell REK. Eosinophils in COPD: Just Another Biomarker? Lancet Respir Med 2017;5:747-59.

Calverley PMA, Tetzlaff K, Vogelmeier C, Fabbri LM, Magnussen H, Wouters EFM, et al. Eosinophilia, Frequent Exacerbations, and Steroid Response in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med 2017;196:1219-21.

Mannino D, Bogart M, Germain G, Huang SP, -Ismaila AS, Laliberté F, et al. Benefit of Prompt versus Delayed Use of Single-Inhaler Fluticasone Furoate/-Umeclidinium/ Vilanterol (FF/UMEC/VI) Following a COPD Exacerbation. Int J Chron Obstruct Pulmon Dis 2022;17:491-504.

Lai CC, Chen CH, Chen KH, Wang CY, Huang TM, Wang YH, et al. The Impact of 52-Week Single -Inhaler Device Triple Therapy versus Dual Therapy on the Mortality of COPD Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Life (Basel) 2022;12:173.

.

Downloads

Published

18-09-2024

Issue

Section

Original Research Articles

How to Cite

1.
Solidoro P, Dente F, Micheletto C, Pappagallo G, Pelaia G, Papi A. An Italian Delphi Consensus on the Triple inhalation Therapy in Chronic Obstructive Pulmonary Disease. Multidiscip Respir Med [Internet]. 2024 Sep. 18 [cited 2024 Oct. 12];19(1). Available from: https://mrmjournal.org/index.php/mrm/article/view/949