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Inhalation OCTOBER2015 21 treat patients who have severe and costly indications such as lung transplantation, idiopathic pulmonary fibrosis and severe COPD, but eventually the technol- ogy should become available for all relevant lung diseases. Challenges in assessing lung health One of the advantages of the conventional lung function tests, yet at the same time is their greatest limitation, is reduction of the heterogeneity of the lung to a single number. The patient's physiology determines which areas in the lung (for example, the peripheral airways, central airways or healthy areas) drive the endpoint mea- sured using lung function tests such as FEV 1 . Subse- quently, that single number can be easily used in univari- ate regression or in t-tests. In contrast, image-based measures to describe and quan- tify lung regions yield a combination of regional parame- ters indicative of changes in lung disease 14 or may even be potentially predictive for future adverse events. 15-19 The challenge will be to convert the multitude of regional information offered by FRI to a composite endpoint that can be easily interpreted relative to clinically mean- ingful thresholds. Then a robust framework based on multi-regression analysis needs to be developed. If this understanding of lung disease heterogeneity can be achieved, we are convinced it will materially improve the lives of many patients. References 1. Jones P, Health status measurement in chronic obstruc- tive pulmonary disease. Thorax. 2001;56:880-887. 2. Food and Drug Administration (FDA). Biomarker Letter of Support to Fluidda (author). June 6, 2016. (http://www.fda.gov/downloads/Drugs/Development ApprovalProcess/UCM506218.pdf). 3. Vos W, Hajian B, De Backer J, Van Holsbeke C, Vinchurkar S, Claes R, et al. Functional respiratory imag- ing to assess the interaction between systemic roflumilast and inhaled ICS/LABA/LAMA. International Journal of Chronic Obstructive Pulmonary Disease. 2016;Feb;263- 271. 4. De Backer W, Vos W, Van Holsbeke C, Vinchurkar S, Claes R, Hufkens A, et al. The effect of roflumilast in addi- tion to LABA/LAMA/ICS treatment in COPD patients. European Respiratory Journal ; 2014Aug;44(2):527-529. 5. Hajian B, de Backer J, Vos W, van Holsbeke C, Ferreira F, Quinn D, et al. Pulmonary vascular effects of pulsed inhaled nitric oxide in COPD patients with pulmonary hypertension. International Journal of Chronic Obstruc- tive Pulmonary Disease. 2016;Jul;11:1533-1141. 6. Rogliani P, Calzetta L, Cavalli F, Matera MG, Cazzola M., Pirfenidone, nintedanib and N-acetylcysteine for the treatment of idiopathic pulmonary fibrosis: A systematic review and meta-analysis. Pulmonary Pharmaco- logy and Therapeutics. 2016;Jul 29; Accepted for publi- cation. 7. Vos W, Van Holsbeke C, Ferreira F, De Backer J, Goldin JG, Porter S, et al. Functional respiratory imaging (FRI) in IPF: Regional information matters. American Journal of Respiratory and Critical Care Medicine. 2016;193:A4988. 8. Vos W, Van Holsbeke C, Ferreira F, Nuyttens L, O'Ri- ordan TG, De Backer J, et al. Comparison of IPF disease pathology to healthy subjects using functional respiratory imaging. American Journal of Respiratory and Critical Care Medicine. 2015;191:A4377. 9. Ferreira F, Verplancke V, Vos W, Van Holsbeke C, De Backer J, De Backer W, et al. Progressive TLC loss after unilateral lung transplantation in IPF: Functional respira- tory imaging differentiates between transplanted and native lung. European Respiratory Journal. 2015;46 (Suppl 59):PA3750. 10. De Backer J, Vos W, Van Holsbeke C, Ferreira F, Nuyttens L, Trehu B, et al. Assessment of IPF disease pathology using functional respiratory imaging. Ameri- can Journal of Respiratory and Critical Care Medicine. 2015;191:A1568. 11. De Backer J, Vos W, Smaldone G, Skaria S, Condos R. Disease progression in IPF assessed using pulmonary function tests and functional respiratory imaging (FRI)— A pilot study. American Journal of Respiratory and Criti- cal Care Medicine. 2014;189:A2383. 12. Food and Drug Administration (FDA). Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment Guidance for Industry Draft Guidance May, 2016. (http://www.fda.gov/downloads/drugs/guidance complianceregulatoryinformation/guidances/ucm07157 5.pdf). 13. Hajian B, De Backer J, Vos W, Van Holsbeke C, Clukers J, De Backer W. Functional respiratory imaging (FRI) for optimizing therapy development and patient care. Expert Review of Respiratory Medicine. 2016;Feb 1;10(2):193-206. 14. Broncholab, an online platform tool for Functional Respiratory Imaging (FRI) in the clinical practice: www.broncholab.com. 15. Vos W, Van Holsbeke C, Van Geffen W, Kerstjens H, Pistolesi M, Usmani O, et al. Lower lobe air trapping is linked to exacerbation recovery rate. American Journal of Respiratory and Critical Care Medicine. 2016;193:A5214. 16. Vos W, Van Holsbeke C, Van Geffen W, Kerstjens H, Pistolesi M, Usmani O, et al. Changes in FEV 1 after recovery from COPD exacerbation are driven by hetero- geneous regional changes in airway caliber and hyperinfla- tion. European Respiratory Journal. 2015;46 (Suppl 59):PA2271. 17. Vos W, Van Holsbeke C, Van Geffen W, Kerstjens H, Pistolesi M, Usmani O, et al. Changes in functional respiratory imaging (FRI) endpoints correlate with