Choosing an inhaler for COPD made simple. Dr Simon Hart Castle Hill Hospital

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1 Choosing an inhaler for COPD made simple Dr Simon Hart Castle Hill Hospital 1

2 Declaration of interests I have received speaker fees, sponsorship to attend conferences, and funding for research from companies that make COPD treatments

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4

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6 What is COPD? characterized by persistent airfow limitation (reduced FEV 1 and FEV 1 /FVC ratio) that is usually progressive a leading cause of morbidity and mortality worldwide and results in an economic and social burden that is both substantial and increasing. Chronic bronchitis Emphysema

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8 Hyperinflation in COPD

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10 Treating airflow obstruction bronchodilators

11 Bronchodilators: relax airway smooth muscle

12 The impact of effective bronchodilation Bronchodilators increase the radius of the small airways and so reduce the resistance of the airflow during breathing Air flow resistance 1/r 4 Airflow is inversely proportional to the radius of the small airway to the power of four 1 r A small change makes a big difference r Bronchoconstriction Bronchodilation 1) Chang DW. Clinical Application of Mechanical Ventilation 2nd Edition. 2005

13 β2 agonist Muscarinic antagonist

14 LAMA/LABA combination inhalers Long acting muscarinic antagonist (LAMA) Long acting beta agonist (LABA) Daily dosing Anoro Umeclidinium 55 mcg Vilanterol 22 mcg One dose Once daily Ultibro Glycopyrronium 50 mcg Indacaterol 110 mcg One dose Once daily Duaklir Aclidinium 340 mcg Formoterol 12 mcg One dose Twice daily Spiolto Tiotropium 2.5 mcg Olodaterol 2.5 mcg Two doses Once daily

15 Summary effects of LABA/LAMA combination versus comparators on changes in trough FEV1 at 3 months, 6 months and 12 months. Yuji Oba et al. Thorax 2016;71:15-25 Copyright BMJ Publishing Group Ltd & British Thoracic Society. All rights reserved.

16 Summary effects of LABA/LAMA combination versus comparators on changes in (A) St. George s Respiratory Questionnaire and (B) Transition Dyspnoea Index at 3 months and 6 months. Yuji Oba et al. Thorax 2016;71:15-25 Copyright BMJ Publishing Group Ltd & British Thoracic Society. All rights reserved.

17 Summary effects of LABA/LAMA combination versus comparators on proportion of SGRQ and TDI responders at 6 months. Yuji Oba et al. Thorax 2016;71:15-25 Copyright BMJ Publishing Group Ltd & British Thoracic Society. All rights reserved.

18 Summary effects of LABA/LAMA combination versus comparators on COPD exacerbations. Yuji Oba et al. Thorax 2016;71:15-25 Copyright BMJ Publishing Group Ltd & British Thoracic Society. All rights reserved.

19 How much do they cost? LAMA alone LAMA/LABA combination

20 Treating airflow obstruction bronchodilators Use a LAMA/LABA combination inhaler

21 Treating airways inflammation Inhaled steroids

22

23 Exacerbation rate 1.32/yr on placebo vs 0.99/yr on fluticasone ISOLDE 2000 TORCH 2007: exacerbations Placebo Salmeterol Fluticasone Salm/Flut mod/severe * 0.93* 0.85* requiring steroids * 0.52* 0.46* hospitalised * * pneumonia 3 year rate 12.3% 13.3% 18.3%* 19.6%*

24 ICS in COPD: benefit vs risk fewer exacerbations more pneumonia local side effects systemic side effects cost

25 Dose response curves for the rate ratio (solid lines) and 95% CIs (dashed lines) of pneumonia as a function of inhaled fluticasone (blue lines) and budesonide (red lines) dose in μg (measured in fluticasone equivalents) estimated by cubic splines model fit by conditional logistic regression. fluticasone budesonide Suissa S et al. Thorax 2013;68: Copyright BMJ Publishing Group Ltd & British Thoracic Society. All rights reserved.

26 Steroid molecule beginning with F Options? Seretide fluticasone propionate + salmeterol Fostair fine particle beclometasone + formoterol Relvar fluticasone furoate + vilanterol Duoresp Spiromax budesonide + formoterol Symbicort

27 Targeted steroid therapy

28 J. bras. pneumol. vol.32 no.3 São Paulo May/June 2006

29 Percentage reduction in moderate/severe exacerbation rates with fluticasone propionate (FP)/salmeterol (SAL) and monocomponents for treatment comparisons of interest in 1-year studies by percentage baseline blood eosinophil level in (A) INSPIRE, (B) TRISTAN and (C) SCO Ian D Pavord et al. Thorax 2016;71: Copyright BMJ Publishing Group Ltd & British Thoracic Society. All rights reserved.

30 Patient 1, aged 72 yrs, COPD 0.16 eosinophil count eosinophil count /09/ /10/ /11/ /12/2015 eosinophil reference range x 10 9 /L

31 Patient 2, aged 71 yrs, COPD 1.2 eosinophil count eosinophil count eosinophil reference range x 10 9 /L

32 Conclusions Treatable traits Airflow obstruction LAMA/LABA combination inhaler Eosinophilic airway inflammation inhaled corticosteroid

33 ICS/LABA LAMA LAMA/LABA cheap ICS Cost saving 35%

34

35 Targeted oral steroid therapy for acute exacerbations of COPD

36 Blood eosinophils to direct corticosteroid treatment of exacerbations of chronic obstructive pulmonary disease: a randomized placebo-controlled trial Bafadhel, M, et al Am J Respir Crit Care Med 2012, 186,

37 Blood eosinophils to direct corticosteroid treatment of exacerbations of chronic obstructive pulmonary disease: a randomized placebo-controlled trial Bafadhel, M, et al Am J Respir Crit Care Med 2012, 186,

38 Consort figure for all analysed data taken from the three randomised control trials Blood eosinophils <2% 2% Intervention placebo prednisolone placebo prednisolone Treatment failure (retreatment, hospitalisation or death within 90 days of randomisation) 16/80 20% 22/84 26% 18/27 66% 12/109 11% Mona Bafadhel et al. Eur Respir J 2014;44: by European Respiratory Society

39 Learning point Blood eosinophils 2% ( 0.15 x 10 9 /L) identify risk and likely steroid responsiveness

40 40

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