The case for extra fine particle ICS:! to cover the entire lung!

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1 The case for extra fine particle ICS: to cover the entire lung Richard J. Martin, M.D. Chairman Department of Medicine National Jewish Health The Edelstein Chair in Pulmonary Medicine Professor of Medicine National Jewish Health University of Colorado Denver No COI or disclosures to report on this topic Learning objectives To understand importance of the small airways in asthma To learn if there is a difference in the inflammatory response between large and small airways To determine if consideration of small airway dysfunction is important in selecting medications

2 Current perspectives Small-airways dysfunction associates with respiratory symptoms and clinical features of asthma: A systematic review " van der Wiel, E, ten Hacken, N, Postma D, and van den Berge, M. " " (JACI 2013;131:646-57)" Anatomic evidence: Airway Obstruction in Asthma Normal Asthma Fatal asthma Courtesy of Bruce Rubin, M.D. Physiologic reason for extra fine particle ICS

3 Peripheral Airways Resistance.08" PAR.06" cm H20/ ml/min.04".02" 0" asthma" asthma normal" p BD" Wagner, et al ARRD 1990; 141:584 Uncoupling of the Airways Nocturnal Inflammation Vol Vol Raw Awake Raw Sleep

4 Awake Coupled - Uncoupling During Sleep Volume Early Upright Supine Late Normal Irvin. AJRCCM 2000; 161:50-56 Posture Sleep Asthma Resistance The Small Airways: Role in Recurrent Exacerbations in Asthma 150 Percent 100 Predicted 50 Unstable asthma Stable asthma p =.02 p =.03 0 RV/ CV/ FEV 1 TLC FRC RV TLC dn 2 VC in t Veen, et al. Am J Respir Crit Care Med. 2000;161: CC/ TLC Does a difference in proximal vs. distal inflammation support the physiologic findings? An inflammatory reason

5

6 40 Eosinophil Location 4 pm 4 am * 40 +" 30 Eos x10 3 / mm NNA NA +" * 0 EBBX TBBX 0 EBBX TBBX Kraft AJRCCM 154;1996 Does particle size of inhaled medication alter lung physiology and inflammation? Suspension vs Solution Aerosols Suspension aerosol Solution aerosol Zeidler M and Corren J. Treat Respir Med. 2004;3:35-44.

7 Lung Attenuation after 4 weeks of EF ICS vs large particle EF significantly reduces air trapping compared to large particle ( p=0.044) Median lung attenuation (Hounsfield units) Pre-Mch p =.048 EF (n=11) Large (n=9) Goldin et al., J Allergy Clin Immunol 104:S258-67, 1999 Post-Mch p =.037 EF particle ICS and eosinophils 100 MBP/mm * * 0 Before After Before After Peripheral Airways Central Airways Hauber, et al. JACI 2003;112: Is there clinical evidence that an extra fine particle size ICS improves drug effectiveness?

8 US (OptumInsight): Cost- effec8veness EF par8cle ICS rela8ve to larger par8cle. Matched cohort y/o, n = 10,312 Less effective More costly Cost Diff $ More effective More costly Effectiveness = Overall Control (Risk and Impairment) Effectiveness Diff Risk = no hospital for asthma, " oral corticosteroids, or " antibiotics for LRI" Impairment 2 puffs saba/day " Less effective Less costly REG Presented at ATS. Under review 2014 More effective Less costly Is there supporting physiologic and clinical evidence that the central and distal airways are different in asthma? Yes Is there evidence to support a differentiation between central and distal inflammation? Yes Does particle size of ICS alter asthma outcome? EF ICS appears to be equal to or have more effectiveness at a lower cost

9 References Hauber HP, Gotfried M, Newman K, et al. Effect of HFA-flunisolide on peripheral lung inflammation in asthma. J Allergy Clin Immunol. 2003;112(1): in 't Veen JC, Beekman AJ, Bel EH, Sterk PJ. Recurrent exacerbations in severe asthma are associated with enhanced airway closure during stable episodes. Am J Respir Crit Care Med. 2000;161(6): Irvin CG, Pak J, Martin RJ. Airway-parenchyma uncoupling in nocturnal asthma. Am J Respir Crit Care Med. 2000;161(1): Kraft M, Djukanovic R, Wilson S, Holgate ST, Martin RJ. Alveolar tissue inflammation in asthma. Am J Respir Crit Care Med. 1996;154(5): van der Wiel E, ten Hacken NH, Postma DS, van den Berge M. Small-airways dysfunction associates with respiratory symptoms and clinical features of asthma: a systematic review. J Allergy Clin Immunol. 2013;131(3): Wagner EM, Liu MC, Weinmann GG, Permutt S, Bleecker ER. Peripheral lung resistance in normal and asthmatic subjects. Am Rev Respir Dis. 1990;141(3): Zeidler M, Corren J. Hydrofluoroalkane formulations of inhaled corticosteroids for the treatment of asthma. Treat Respir Med. 2004;3(1):35-44.

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