Quarterly Pulmonary Update Summer 2019 | Page 4

NON PROFIT U.S. Postage PA ID Permit #1256 Birmingham, AL 410 • 500 22nd Street South 1530 3rd Avenue South Birmingham, AL 35294-0104 uabmedicine.org/learnmd FOR FREE CME CREDIT UAB MEDICINE PULMONARY SERVICES | SUMMER 2019 INSIDE THIS ISSUE: • Exponential Growth of the UAB Interventional Pulmonology Program • Tele-ICU Partnership Connects UAB and the Community • Triple-Combination Drug Benefits 90% of CF Patients • Metformin Reverses Established Lung Fibrosis Contact UAB Medicine’s 24-hour consultation and referral service at 800.UAB.MIST or [email protected]. CLINICAL TRIALS PUBLICATIONS • Smart Telehealth Exercise Intervention to Reduce COPD Readmissions - PI: Surya P. Bhatt, MD This is a prospective randomized controlled study to test the hypothesis that neuromuscular electrical stimulation (NMES) and remote pulmonary rehabilitation at home, offered via a smart technology called Smart Telehealth (later renamed Video Telehealth), reduce systemic inflammation via reduction of skeletal muscle tissue inflammation, thereby improving functional capacity and reducing the rate of readmissions following hospitalization for acute exacerbations of chronic obstructive pulmonary disease (COPD ). Davies JC, Moskowitz SM, Brown C, Horsley A, Mall MA, McKone EF, Plant BJ, Prais D, Ramsey BW, Taylor-Cousar JL, Tullis E, Uluer A, McKee CM, Robertson S, Shilling RA, Simard C, Van Goor F, Waltz D, Xuan F, Young T, Rowe SM; VX16-659-101 Study Group. VX-659-Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis and One or Two Phe508del Alleles. N Engl J Med. 2018 Oct 25;379(17):1599-1611. • The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor – PI: Mark Dransfield, MD This is a phase 2 study to establish the safety and efficacy of a drug called ivacaftor (VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis, and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot, randomized (3:1, active:placebo), double-blind, placebo-controlled study. Approximately 40 subjects with COPD will be randomized. • VX-770 for the Treatment of Chronic Bronchitis - PI: George Solomon, MD This study will test how well a new drug affects bronchiectasis or chronic bronchitis. The new drug, ivacaftor (Kalydeco), recently was approved by the U.S. Food and Drug Administration for patients with cystic fibrosis. It has not been approved for use in patients with bronchiectasis or chronic bronchitis. • GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis - PI: Steven R. Duncan, MD (Program Director: Victor Thannickal, MD) A placebo-controlled, multicenter, randomized trial to test GKT137831 in ambulatory patients with idiopathic pulmonary fibrosis. The investigators hypothesize that the drug will decrease pulmonary injury due to reactive oxygen species (ROS) generated by NOX enzymes, which are believed to play an important role in the development of IPF. For more information or to contact a clinical trial team, visit xpertdox.com/uab-trial. Bhatt SP, Patel SB, Anderson EM, Baugh D, Givens T, Schumann C, Sanders JG, Windham ST, Cutter GR, Dransfield MT. Video Telehealth Pulmonary Rehabilitation Intervention In COPD Reduces 30-day Readmissions. Am J Respir Crit Care Med. 2019 Apr 12. [Epub ahead of print] Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Zouk AN, Gulati S, Heideman BE, Lester MG, Toporek AH, Bentov I, Self WH, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2019 Feb 28;380(9):811-821. Genschmer KR, Russell DW, Lal C, Szul T, Bratcher PE, Noerager BD, Abdul Roda M, Xu X, Rezonzew G, Viera L, Dobosh BS, Margaroli C, Abdalla TH, King RW, McNicholas CM, Wells JM, Dransfield MT, Tirouvanziam R, Gaggar A, Blalock JE. Activated PMN Exosomes: Pathogenic Entities Causing Matrix Destruction and Disease in the Lung. Cell. 2019 Jan 10;176(1-2):113-126. Bhatt SP, Balte PP, Schwartz JE, Cassano PA, Couper D, Jacobs DR Jr, Kalhan R, O’Connor GT, Yende S, Sanders JL, Umans JG, Dransfield MT, Chaves PH, White WB, Oelsner EC. Discriminative Accuracy of FEV1:FVC Thresholds for COPDRelated Hospitalization and Mortality. JAMA. 2019 Jun 25;321(24):2438- 2447. Rangarajan S, Bone NB, Zmijewska AA, Jiang S, Park DW, Bernard K, Locy ML, Ravi S, Deshane J, Mannon RB, Abraham E, Darley-Usmar V, Thannickal VJ, Zmijewski JW. Metformin reverses established lung fibrosis in a bleomycin model. Nat Med. 2018 Aug;24(8):1121-1127.