@article{35488736a1e140c9a4bcc5636070683f,
title = "Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study",
abstract = "Introduction: The phase 3 InforMing the PAthway of COPD (chronic obstructive pulmonary disease) Treatment (IMPACT) trial, single-inhaler therapy with fluticasone furoate (FF) 100 μg, umeclidinium (UMEC) 62.5 μg, and vilanterol (VI) 25 μg demonstrated a reduction in the rate of moderate or severe exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic COPD at risk of exacerbations. This article reports additional evidence of improvements in symptoms and health-related quality of life (HRQoL) with FF/UMEC/VI compared with either FF/VI or UMEC/VI from the IMPACT study. Methods: Patient-reported HRQoL assessments and symptom measures included as pre-specified IMPACT end points were the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI) in a subset of patients enrolled at study sites in North America and Europe. Change from baseline was assessed at weeks 4, 28, and 52. Results: The intent-to-treat population included 10,355 patients (TDI population: 5058 patients). Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI (− 1.8 units, p < 0.001) and UMEC/VI (− 1.8 units, p < 0.001). Similar improvements in the CAT and TDI focal score were also observed with FF/UMEC/VI versus FF/VI or UMEC/VI. Conclusions: This study demonstrates that in patients with symptomatic COPD at risk of exacerbations, once-daily FF/UMEC/VI, compared with FF/VI or UMEC/VI, improves patient-perceived HRQoL and symptoms. Trial Registration Number: NCT02164513.",
keywords = "COPD, Exacerbations, Health-related quality of life, IMPACT trial, Patient-reported outcomes, Single-inhaler triple therapy",
author = "Maggie Tabberer and Jones, {C. Elaine} and Sally Kilbride and Halpin, {David M.G.} and Lomas, {David A.} and Steven Pascoe and Dave Singh and Wise, {Robert A.} and Criner, {Gerard J.} and Peter Lange and Dransfield, {Mark T.} and Han, {Mei Lan K.} and Martinez, {Fernando J.} and Kaisermann, {Morrys C.} and Lipson, {David A.}",
note = "Funding Information: The authors thank the patients and physicians who participated in the IMPACT trial, without whom this study would not have been possible. Trademarks are the property of their respective owners. Dave Singh is supported by the National Institute for Health Research (NIHR) Manchester Biomedical Research Centre (BRC). Funding Information: This study was funded by GlaxoSmithKline plc (CTT116855; clinicaltrials.gov ID: NCT02164513). GlaxoSmithKline plc also funded the Rapid Service and Open Access Fee for this manuscript. Funding Information: Editorial support (in the form of writing assistance, collating author comments, assembling tables/figures, grammatical editing, fact checking, and referencing) was provided by Sarah Birch, PhD, Contract Senior Medical Writer, and Molly Macpherson, BSc, Senior Medical Writer, of Gardiner-Caldwell Communications (Macclesfield, UK), and was funded by GlaxoSmithKline plc. Funding Information: Maggie Tabberer, C. Elaine Jones, Sally Kilbride, Morrys C. Kaisermann, and David A. Lipson are employees of, and hold stocks/shares in, GlaxoSmithKline plc. David M.G. Halpin has received personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline plc, Novartis, Pfizer and Sanofi, and non-financial support from Boehringer Ingelheim and Novartis. David A. Lomas has received grant income, honoraria, and consultancy fees from GlaxoSmithKline plc, and personal fees from Grifols, and chaired the GSK Respiratory Therapy Area Board 2012–2015. Steven Pascoe was an employee of GlaxoSmithKline plc at the time of the study, holds stocks in GlaxoSmithKline plc, and is currently an employee of CSL Behring. Dave Singh has received personal fees from GlaxoSmithKline plc, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Genentech, Glenmark, Menarini, Mundipharma, Novartis, Peptinnovate, Pfizer, Pulmatrix, Theravance and Verona, and grant support from AstraZeneca, Boehringer Ingelheim, Chiesi, Glenmark, Menarini, Mundipharma, Novartis, Pfizer, Pulmatrix, Theravance and Verona. Robert A. Wise has received received personal fees from AstraZeneca/MedImmune, Boehringer Ingelheim, ContraFect, Pulmonx, Roche, Spiration, Sunovion, Merck, Circassia, Pneuma, Verona, Bonti, Denali, Aradigm, Mylan/Theravance, Propeller Health, AbbVie and GSK, and grant support from AstraZeneca/MedImmune, Boehringer Ingelheim, Pearl Therapeutics, GSK, and Sanofi-Aventis. Gerard Criner has received personal fees from Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Broncus Medical, Chiesi, CSA Medical, Eolo, Gala Therapeutics, GSK, Helios Medical, Medtronic, Merck, Mereo BioPharma, NGM Pharmaceuticals, Novartis, Nuvaira, Olympus, Philips Respironics, Pulmonx, Respivant Sciences, The Implementation Group, and Verona. He also has ownership interest in HGE Technologies. Peter Lange has received personal fees from GlaxoSmithKline plc, AstraZeneca, and Boehringer Ingelheim, and grant support from Boehringer Ingelheim and GlaxoSmithKline plc. Mark T. Dransfield has received personal fees from AstraZeneca, Boehringer Ingelheim, PneumRx/BTG, Quark Pharmaceuticals and GlaxoSmithKline plc, grant support from the American Lung Association, Department of Defense, Department of Veterans Affairs, and NIH, and contracted clinical trial support from Boehringer Ingelheim, Novartis, AstraZeneca, Yungjin, PneumRx/BTG, Pulmonx, Boston Scientific, Gala, Nuvaira, and GlaxoSmithKline plc. Fernando J. Martinez has received personal fees and non-financial support from the American College of Chest Physicians, AstraZeneca, Boehringer Ingelheim, Continuing Education, ConCert, Genentech, GlaxoSmithKline plc, Inova Fairfax Health System, Miller Communications, National Society for Continuing Education, Novartis, Pearl Pharmaceuticals, PeerView Communications, Prime Communications, Puerto Rico Respiratory Society, Chiesi, Roche, Sunovion, Theravance, Potomac, University of Alabama Birmingham, Physicians Education Resource, Canadian Respiratory Network and Teva, non-financial support from ProterrixBio, Gilead, Nitto and Zambon, and personal fees from Columbia University, Integritas, MD Magazine, Methodist Hospital Brooklyn, New York University, Unity, UpToDate, WedMD/MedScape, Western Connecticut Health Network, Academic CME, Patara, PlatformIQ, American Thoracic Society, Rockpointe and France Foundation, grant support from NIH, Rare Disease Health Communications and ProMedior, and is a member of steering committees for Afferent/Merck, Biogen, Veracyte, Prometic, Bayer and Bridge Biotherapeutics. ",
year = "2020",
month = sep,
day = "1",
doi = "10.1007/s12325-020-01409-8",
language = "English (US)",
volume = "37",
pages = "3775--3790",
journal = "Advances in Therapy",
issn = "0741-238X",
publisher = "Health Communications Inc.",
number = "9",
}