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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 3775-3790 |
| Number of pages | 16 |
| Journal | Advances in Therapy |
| Volume | 37 |
| Issue number | 9 |
| DOIs | |
| State | Published - Sep 1 2020 |
| Externally published | Yes |
Keywords
- COPD
- Exacerbations
- Health-related quality of life
- IMPACT trial
- Patient-reported outcomes
- Single-inhaler triple therapy
ASJC Scopus subject areas
- Pharmacology (medical)
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Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD : The IMPACT Study. / Tabberer, Maggie; Jones, C. Elaine; Kilbride, Sally; Halpin, David M.G.; Lomas, David A.; Pascoe, Steven; Singh, Dave; Wise, Robert A.; Criner, Gerard J.; Lange, Peter; Dransfield, Mark T.; Han, Mei Lan K.; Martinez, Fernando J.; Kaisermann, Morrys C.; Lipson, David A.
In: Advances in Therapy, Vol. 37, No. 9, 01.09.2020, p. 3775-3790.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD
T2 - The IMPACT Study
AU - Tabberer, Maggie
AU - Jones, C. Elaine
AU - Kilbride, Sally
AU - Halpin, David M.G.
AU - Lomas, David A.
AU - Pascoe, Steven
AU - Singh, Dave
AU - Wise, Robert A.
AU - Criner, Gerard J.
AU - Lange, Peter
AU - Dransfield, Mark T.
AU - Han, Mei Lan K.
AU - Martinez, Fernando J.
AU - Kaisermann, Morrys C.
AU - Lipson, David A.
N1 - 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). 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. 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. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Maggie Tabberer, Steven Pascoe, and David A. Lipson: study design, data analysis, and interpretation. Gerard J. Criner and Mark T. Dransfield: data acquisition and interpretation. C. Elaine Jones, Sally Kilbride, David M.G. Halpin, David A. Lomas, Dave Singh, Robert A. Wise, Peter Lange, MeiLan K. Han, Fernando J. Martinez, and Morrys C. Kaisermann: data analysis and interpretation. 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. These data were presented at the ERS International Congress 2018 (Tabberer M, et al. European Respiratory Journal 2018 52: OA1658. Tabberer M, et al. European Respiratory Journal 2018 52: PA1996) and at the American Thoracic Society 2019 International Conference (Kaisermann M, et al, American Journal of Respiratory and Critical Care Medicine 2019;199:A3347). IMPACT was conducted in accordance with Good Clinical Practice guidelines and the provisions of the Declaration of Helsinki and received approval from local institutional review boards or independent ethics committees. Informed consent was obtained from all participants. Anonymised individual participant data and study documents can be requested for further research from www.clinicalstudydatarequest.com. 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: 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: 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. Publisher Copyright: © 2020, The Author(s).
PY - 2020/9/1
Y1 - 2020/9/1
N2 - 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.
AB - 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.
KW - COPD
KW - Exacerbations
KW - Health-related quality of life
KW - IMPACT trial
KW - Patient-reported outcomes
KW - Single-inhaler triple therapy
UR - http://www.scopus.com/inward/record.url?scp=85087680300&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85087680300&partnerID=8YFLogxK
U2 - 10.1007/s12325-020-01409-8
DO - 10.1007/s12325-020-01409-8
M3 - Article
C2 - 32647911
AN - SCOPUS:85087680300
VL - 37
SP - 3775
EP - 3790
JO - Advances in Therapy
JF - Advances in Therapy
SN - 0741-238X
IS - 9
ER -