INDIVIDUALIZED APPROACH, EVIDENCE, PRACTICE (BASED ON PROCEEDINGS OF THE 26TH NATIONAL CONGRESS ON RESPIRATORY DISEASES)

1. Herland K., Akselsen J.P., Skjǿnsberg O.H. et al. How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease? Respir. Med. 2005; 99: 11–19.

2. Treweek S., Zwarenstein M. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials. 2009; 10: 37.

3. Godwin M., Ruhland L., Casson I. et al. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med. Res. Methodol. 2003; 3: 28.

4. ABPI. The Vision for Real World Data – Harnessing the opportunities in the UK. White Paper, September 2011. Available at http://www.abpi.org.uk/our-work/library/industry/Documents/Vision-for-Real-World-Data.pdf

5. Bateman E.D., Boushey H.A., Bousquet J. et al. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am. J. Respir. Crit. Care Med. 2004; 170: 836–844.

6. Busse W.W., Shailen R.S., Somerville L. et al. Comparison of adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler and fixed-dose fluticasone propionate/salmeterol dry powder inhaler in asthma patients. J. Allergy Clin. Immunol. 2008; 121 (6): 1407–1414. DOI: 10.1016/j.jaci.2008.03.019.

7. Vestbo J., Anderson J.A., Calverley P.M.A. et al. Adherence to inhaled therapy, mortality and hospital admission in COPD. Thorax. 2009; 64: 939–943.

8. Papi A., Paggiaro P.L., Nicolini G. et al. Inhaled Combination Asthma Treatment versus SYmbicort (ICAT SY) Study Group: beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma. Eur. Respir. J. 2007; 29: 682–689.

9. Breekveldt-Postma N.S., Koerselman J., Erkens J.A. et al. Treatment with inhaled corticosteroids in asthma is too often discontinued. Pharmacoepidemiol. Drug Saf. 2008; 17: 411–422.

10. Janson C., de Marco R., Accordini S. et al. Changes in the use of anti-asthmatic medication in an international cohort. Eur. Respir. J. 2005; 26: 1047–1055.

11. Adams R.J., Fuhlbrigge A., Guilbert T. et al. Inadequate use of asthma medication in the United States: Results of the asthma in America national population survey. J. Allergy Clin. Immunol. 2002; 110: 58–64.

12. Ställberg B., Nystrom K.U., Olsson P. et al. Living with asthma in Sweden – the ALMA study. Respir. Med. 2003; 97: 835–843.

13. de Marco R., Cazzoletti L., Cerveri I. et al. Are the asthma guideline goals achieved in daily practice? A population-based study on treatment adequacy and the control of asthma. Int. Arch. Allergy Immunol. 2005; 138: 225–234.

14. Corrigan C.J. Asthma therapy: there are guidelines, and then there is real life. Prim. Care Respir. J. 2011; 20: 13–14.

15. Vestbo J., Leather D., Bakerly N.D. et al. Effectiveness of fluticasone furoate–vilanterol for COPD in clinical practice. N. Eng. J. Med. 2016; 375: 1253–1260.

16. Agusti A., Calverley P.M., Celli B. et al. Characterisation of COPD heterogeneity in the ECLIPSE cohort. Respir. Res. 2010; 11: 122.

17. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. GOLD, 2016. Available at www.goldcopd.com

18. Casanova C., Marin J.M., Martinez-Gonzalez C. et al. New GOLD classification: longitudinal data on group assignment. Respir. Res. 2014; 15: 3–12.

19. Nannini L.J., Lasserson T.J., Poole P. Combined corticosteroid and long-acting beta(2)-agonist in one inhaler versus long-acting beta(2)-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst. Rev. 2012; (9): CD006829.

20. Nannini L.J., Poole P., Milan S.J. et al. Combined corticosteroid and long-acting beta(2)-agonist in one inhaler versus inhaled corticosteroids alone for chronic obstructive pulmonary disease. Cochrane Database Syst. Rev. 2013; (8): CD006826.

21. Dransfield M.T., Bourbeau J., Jones P.W. et al. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. Lancet Respir. Med. 2013; 1: 210–223.

22. Sharafkhaneh A., South J.G., Goldman M. et al. Effect of budesonide/formoterol pMDI on COPD exacerbations: a double-blind, randomized study. Respir Med. 2012; 106: 257–268.

23. Wedzicha J.A., Singh D., Vestbo J. et al. Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations. Respir. Med. 2014; 108: 1153–1162.

24. Kardos P., Wencker M., Glaab T. et al. Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care Med. 2007; 175: 144–149.

25. EMA completes review of inhaled corticosteroids for chronic obstructive pulmonary disease. EMA/488280/2016. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Inhaled_corticosteroids_Article_31/European_Commission_final_decision/WC500210489.pdf

26. Siddiqui S.H., Guasconi A., Vestbo J. et al. Blood Eosinophils: A biomarker of response to extrafine beclomethasone/formoterol in chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care Med. 2015; 192: 523–525.

27. Pascoe S., Locantore N., Dransfield M.T. et al. Blood eosinophil counts, exacerbations, and response to the addition of inhaled fluticasone furoate to vilanterol in patients with chronic obstructive pulmonary disease: A secondary analysis of data from two parallel randomised controlled trials. Lancet Respir. Med. 2015; 3: 435–442.

28. Pavord I.D., Lettis S., Locantore N. et al. Blood eosinophils and inhaled corticosteroid/long-acting b2-agonist efficacy in COPD. Thorax. 2016; 7: 118–125.

29. Watz H., Tetzlaff K., Wouters E.F.M. et al. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial. Lancet Respir. Med. 2016; 4: 390–398.

30. Müllerová H., Lu C., Li H. et al. Prevalence and burden of breathlessness in patients with chronic obstructive pulmonary disease. PLoS ONE. 2014; 9 (1): e85540.

31. Buhl R., Maltais F., Abrahams R. et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2–4). Eur. Respir. J. 2015; 45: 869–871.

32. Bateman E.D., Ferguson G.T., Barnes N. et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur. Respir. J. 2013; 42: 1484–1494.

33. Maleki-Yazdi M.R., Kaelin T., Richard N. et al. Efficacy and safety of umeclidinium/vilanterol 62.5/25 mcg and tiotropium 18 mcg in chronic obstructive pulmonary disease: results of a 24-week, randomized, controlled trial. Respir. Med. 2014; 108: 1752–1760.

34. Maleki-Yazdi M.R., Singh D., Anzueto A. et al. Assessing short-term deterioration in maintenance-naïve patients with COPD receiving umeclidinium/vilanterol and tiotropium: a pooled analysis of three randomized trials. Adv. Ther. 2017; 33: 2188–2199. Epub. Oct. 28, 2016.

35. Calzetta L., Matera M.G., Cazzola M. Pharmacological interaction between LABAs and LAMAs in the airways: optimizing synergy. Eur. J. Pharmacol. 2015; 761:168–173.

36. Agusti A. The path to personalized medicine in COPD. Thorax. 2014; 69: 857–864.