POPE study: rationale and methodology of a study to phenotype patients with COPD in Central and Eastern Europe

. 2016 ; 11 () : 611-22. [epub] 20160322

Jazyk angličtina Země Nový Zéland Médium electronic-ecollection

Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie

Perzistentní odkaz   https://www.medvik.cz/link/pmid27042048

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) constitutes a major health challenge in Central and Eastern European (CEE) countries. However, clinical phenotypes, symptom load, and treatment habits of patients with COPD in CEE countries remain largely unknown. This paper provides a rationale for phenotyping COPD and describes the methodology of a large study in CEE. METHODS/DESIGN: The POPE study is an international, multicenter, observational cross-sectional survey of patients with COPD in CEE. Participation in the study is offered to all consecutive outpatients with stable COPD in 84 centers across the CEE region if they fulfill the following criteria: age >40 years, smoking history ≥10 pack-years, a confirmed diagnosis of COPD with postbronchodilator FEV1/FVC <0.7, and absence of COPD exacerbation ≥4 weeks. Medical history, risk factors for COPD, comorbidities, lung function parameters, symptoms, and pharmaceutical and nonpharmaceutical treatment are recorded. The POPE project is registered in ClinicalTrials.gov with the identifier NCT02119494. OUTCOMES: The primary aim of the POPE study was to phenotype patients with COPD in a real-life setting within CEE countries using predefined classifications. Secondary aims of the study included analysis of differences in symptoms, and diagnostic and therapeutic behavior in participating CEE countries. CONCLUSION: There is increasing acceptance toward a phenotype-driven therapeutic approach in COPD. The POPE study may contribute to reveal important information regarding phenotypes and therapy in real-life CEE.

Zobrazit více v PubMed

Goldcopd.com [homepage on the Internet] Global Initiative for Chronic Obstructive Lung Disease; Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. c2013. [Accessed November 8, 2014]. [updated January 2014; cited November 8, 2014]. Available from: http://www.goldcopd.org/uploads/users/files/GOLD_Report_2014_Jun11.pdf.

Erswhitebook.org [homepage on the Internet] European Lung White Book; European Respiratory Society. c2013. [Accessed August 6, 2015]. [updated 2015; cited August 6, 2015]. Available from: http://www.erswhitebook.org/chapters/chronic-obstructive-pulmonary-disease/

Buist AS, McBurnie MA, Vollmer WM, et al. International variation in the prevalence of COPD (the BOLD Study): a population-based prevalence study. Lancet. 2007;370(9589):741–750. PubMed

Whoint [homepage on the Internet] Chronic obstructive pulmonary disease (COPD) World Health Organisation; c2007. [Accessed August 6, 2015]. [updated January 2015; cited August 6, 2015]. Available from: http://www.who.int/mediacentre/factsheets/fs315/en/

Lopez AD, Shibuya K, Rao C, et al. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J. 2006;27(2):397–412. PubMed

Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011;155(3):179–191. PubMed

De Marco R, Accordini S, Antò JM, et al. Long-term outcomes in mild/moderate chronic obstructive pulmonary disease in the European Community Respiratory Health Survey. Am J Respir Crit Care Med. 2009;180(10):956–963. PubMed

Gould NS, Min E, Gauthier S, et al. Aging adversely affects the cigarette smoke–induced glutathione adaptive response in the lung. Am J Respir Crit Care Med. 2010;182(9):1114–1122. PubMed PMC

Barrecheguren M, Esquinas C, Miravitlles M. The asthma-chronic obstructive pulmonary disease overlap syndrome (ACOS): opportunities and challenges. Curr Opin Pulm Med. 2015;21(1):74–79. PubMed

Soler-Cataluña JJ, Cosío B, Izquierdo JL, et al. Consensus document on the overlap phenotype COPD-asthma in COPD. Arch Bronconeumol. 2012;48(9):331–337. PubMed

Weiss ST. What genes tell us about the pathogenesis of asthma and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010;181(11):1170–1173. PubMed

Matkovic Z, Tudoric N, Miravitlles M. Impact of chronic bronchial infection in the lung and beyond. Eur Respir Mon. 2013;60:46–57.

Hnizdo E, Sullivan PA, Bang KM, Wagner G. Association between chronic obstructive pulmonary disease and employment by industry and occupation in the US population: a study of data from the Third National Health and Nutrition Examination Survey. Am J Epidemiol. 2002;156(8):738–746. PubMed

Torres-Duque C, Maldonado D, Pérez-Padilla R, et al. Biomass fuels and respiratory diseases. Proc Am Thorac Soc. 2008;5(5):577–590. PubMed

Leuppi JD, Schuetz P, Bingisser R, et al. Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial. JAMA. 2013;309(21):2223–2231. PubMed

Qaseem A, Hopkins R, Kutty K, et al. homepage on the Internet . Management of Chronic Obstructive Pulmonary Disease: Review of the Performance Measures by the Performance Measurement Committee of the American College of Physicians. American College of Physicians; c2015. [Accessed August 6, 2015]. [updated 2015; cited August 6, 2015]. Available from: http://www.acponline.org/clinical_information/performance_measurement/measures/pmc_copd_review.pdf.

Tashkin DP, Rennard SI, Uryniak T, et al. Effect Of Budesonide/Formoterol (BUD/FM) Versus FM Alone On The Rate Of Exacerbations (Either Including Or Excluding The Use Of Antibiotics As Part Of Exacerbation Definition), Lung Function, And Rescue Medication Use In Patients With Moderate To Very Severe Chronic Obstructive Pulmonary Disease (COPD). B39 COPD exacerbations: precipitating factors, prevention, and outcome [homepage on the Internet] American Thoracic Society; 2014. [Accessed August 6, 2015]. pp. A2882–A2882. c1998–2015 [updated 2015; cited August 6, 2015]. Available from: http://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2014.189.1_MeetingAbstracts.A2882. DOI

Montuschi P, Malerba M, Santini G, Miravitlles M. Pharmacological treatment of chronic obstructive pulmonary disease: from evidence-based medicine to phenotyping. Drug Discov Today. 2014;19(12):1928–1935. PubMed

Dong YH, Lin HH, Shau WY, et al. Comparative safety of inhaled medications in patients with chronic obstructive pulmonary disease: systematic review and mixed treatment comparison meta-analysis of randomised controlled trials. Thorax. 2013;68(1):48–56. PubMed

Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013;1(3):199–209. PubMed

Barnes N, Calverley PM, Kaplan A, Rabe KF. Chronic obstructive pulmonary disease and exacerbations: patient insights from the global Hidden Depths of COPD survey. BMC Pulm Med. 2013;13:54. PubMed PMC

Emerman CL. Effectiveness of inhaled steroids in the management of chronic obstructive pulmonary disease. Curr Emerg Hosp Med Rep. 2013;1(4):189–192.

Jayaram L, Wong C, McAuley S, et al. Combined therapy with tiotropium and formoterol in chronic obstructive pulmonary disease: effect on the 6-minute walk test. COPD. 2013;10(4):466–472. PubMed

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–383. PubMed

Thoracic.org [homepage on the Internet] ATS documents: statements, guidelines & reports. American Thoracic Society. c1998–2015. [Accessed February 12, 2015]. [updated 2015; cited February 12, 2015]. Available from: http://www.thoracic.org/statements/

Bestall JC, Paul EA, Garrod R, et al. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999;54(7):581–586. PubMed PMC

Jones PW, Harding G, Berry P, et al. Development and first validation of the COPD assessment test. Eur Respir J. 2009;34(3):648–654. PubMed

Miravitlles M, Barrecheguren M, Roman-Rodriguez M. Frequency and characteristics of different clinical phenotypes of COPD. Int J Tuberc Lung Dis. 2015;19(8):992–998. PubMed

Miravitlles M, Soler-Cataluña JJ, Calle M, Soriano JB. Treatment of COPD by clinical phenotypes: putting old evidence into clinical practice. Eur Respir J. 2013;41(6):1252–1256. PubMed

Higgins V, Price D, Baker CL, et al. Real-world characterization and differentiation of the Global Initiative for Chronic Obstructive Lung Disease strategy classification. Int J Chron Obstruct Pulmon Dis. 2014;9:551–561. PubMed PMC

Bang KM. Chronic obstructive pulmonary disease in nonsmokers by occupation and exposure: a brief review. Curr Opin Pulm Med. 2015;21(2):149–154. PubMed

Zielinski J, Bednarek M, Górecka D, et al. Increasing COPD awareness. Eur Respir J. 2006;27(4):833–852. PubMed

Nadkarni PM, Brandt CM, Frawley S, et al. Managing attribute – value clinical trials data using the ACT/DB client – server database system. J Am Med Inform Assoc. 1998;5(2):139–151. PubMed PMC

Nadkarni PM, Brandt CM, Marenco L. WebEAV: automatic metadata-driven generation of web interfaces to entity-attribute-value databases. J Am Med Inform Assoc. 2000;7(4):343–356. PubMed PMC

Nadkarni PM, Marenco L. Easing the transition between attribute-value databases and conventional databases for scientific data. Proc AMIA Symp. 2001:483–487. PubMed PMC

Schiavi E, Stirbulov R, Hernández Vecino R, et al. COPD screening in primary care in four Latin American countries: methodology of the PUMA study. Arch Bronconeumol. 2014;50(11):469–474. PubMed

Han MK, Agusti A, Calverley PM, et al. Chronic obstructive pulmonary disease phenotypes. Am J Respir Crit Care Med. 2010;182(5):598–604. PubMed PMC

Lee YM. Chronic obstructive pulmonary disease: respiratory review of 2014. Tuberc Respir Dis (Seoul) 2014;77(4):155–160. PubMed PMC

Blasi F, Chalmers JD, Aliberti S. COPD and bronchiectasis: phenotype, endotype or co-morbidity. COPD. 2014;11(6):603–604. PubMed

Novotna B, Koblizek V, Zatloukal J, et al. Czech multicenter research database of severe COPD. Int J Chron Obstruct Pulmon Dis. 2014;9:1265–1274. PubMed PMC

Allen-Ramey FC, Gupta S, DiBonaventura MD. Patient characteristics, treatment patterns, and health outcomes among COPD phenotypes. Int J Chron Obstruct Pulmon Dis. 2012;7:779–787. PubMed PMC

Koblizek V, Chlumsky J, Zindr V, et al. Chronic Obstructive Pulmonary Disease: official diagnosis and treatment guidelines of the Czech Pneumological and Phthisiological Society; a novel phenotypic approach to COPD with patient-oriented care. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2013;157(2):189–201. PubMed

Miravitlles M, Soler-Cataluña JJ, Calle M, et al. Spanish guideline for COPD (GesEPOC). Update 2014. Arch Bronconeumol. 2014;50(Suppl 1):1–16. PubMed

Louie S, Zeki AA, Schivo M, et al. The asthma-chronic obstructive pulmonary disease overlap syndrome: pharmacotherapeutic considerations. Expert Rev Clin Pharmacol. 2013;6(2):197–219. PubMed PMC

Miravitlles M, Soler-Cataluña JJ, Cale M, et al. A new approach to grading and treating COPD based on clinical phenotypes: summary of the Spanish COPD guidelines (GesEPOC) Prim Care Respir J. 2013;22(1):117–121. PubMed PMC

Burgel PR, Paillasseur JL, Peene B, et al. Two distinct chronic obstructive pulmonary disease (COPD) phenotypes are associated with high risk of mortality. PLoS One. 2012;7(12):e51048. PubMed PMC

Garcia-Aymerich J, Gómez FP, Benet M, et al. Identification and prospective validation of clinically relevant chronic obstructive pulmonary disease (COPD) subtypes. Thorax. 2011;66(5):430–437. PubMed

Magnussen H, Disse B, Rodriguez-Roisin R, et al. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014;371(14):1285–1294. PubMed

Rossi A, Guerriero M, Corrado A. Withdrawal of inhaled corticosteroids can be safe in COPD patients at low risk of exacerbation: a real-life study on the appropriateness of treatment in moderate COPD patients (OPTIMO) Respir Res. 2014;15:77. PubMed PMC

Gershon AS, Campitelli MA, Croxford R, et al. Combination long-acting β-agonists and inhaled corticosteroids compared with long-acting β-agonists alone in older adults with chronic obstructive pulmonary disease. JAMA. 2014;312(11):1114–1121. PubMed

Rennard SI, Calverley PM, Goehring UM, et al. Reduction of exacerbations by the PDE4 inhibitor roflumilast-the importance of defining different subsets of patients with COPD. Respir Res. 2011;12:18. PubMed PMC

Nizankowska-Mogilnicka E, Mejza F, Buist AS, et al. Prevalence of COPD and tobacco smoking in Malopolska region-results from the BOLD study in Poland. Pol Arch Med Wewn. 2007;117(9):402–410. PubMed

Golec M, Skórska C, Mackiewicz B, et al. Relationship between COPD and lower socioeconomic status in farmers from South-Eastern Poland (Lublin region) Rural Remote Health. 2014;14:2531. PubMed

Eea.europa.eu [homepage on the Internet] European environment agency; Air quality in Europe – 2014 report. c2015. [Accessed August 6, 2015]. p. 35. [updated July 30, 2015; cited August 6, 2015]. Available from: http://www.eea.europa.eu/publications/air-quality-in-europe-2014.

Camp PG, Ramirez-Venegas A, Sansores RH, et al. COPD phenotypes in biomass smoke-versus tobacco smoke-exposed Mexican women. Eur Respir J. 2014;43(3):725–734. PubMed

Davidova J, Praznovcova L, Lundborg CS. Pricing and reimbursement of pharmaceuticals in the Czech Republic and Sweden. Pharm World Sci. 2008;30(1):57–64. PubMed

Celli BR, MacNee W, Agusti A, et al. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004;23(6):932–946. PubMed

Bellamy D, Bouchard J, Henrichsen S, et al. International Primary Care Respiratory Group (IPCRG) guidelines: management of chronic obstructive pulmonary disease (COPD) Prim Care Respir J. 2006;15(1):48–57. PubMed PMC

Jones PW, Brusselle G, Dal Negro RW, et al. Patient-centred assessment of COPD in primary care: experience from a cross-sectional study of health- related quality of life in Europe. Prim Care Respir J. 2012;21(3):329–336. PubMed PMC

Zobrazit více v PubMed

ClinicalTrials.gov
NCT02119494

Najít záznam

Citační ukazatele

Nahrávání dat ...

Možnosti archivace

Nahrávání dat ...