Abstract

Chronic obstructive pulmonary disease (COPD) treatment guidelines do not currently include recommendations for escalation directly from monotherapy to triple therapy. This 12-week, double-blind, double-dummy study randomized 800 symptomatic moderate-to-very-severe COPD patients receiving tiotropium (TIO) for ≥3 months to once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mcg via ELLIPTA (n = 400) or TIO 18 mcg via HandiHaler (n = 400) plus matched placebo. Study endpoints included change from baseline in trough forced expiratory volume in 1 s (FEV1) at Days 85 (primary), 28 and 84 (secondary), health status (St George’s Respiratory Questionnaire [SGRQ] and COPD Assessment Test [CAT]) and safety. FF/UMEC/VI significantly improved trough FEV1 at all timepoints (Day 85 treatment difference [95% CI] 95 mL [62–128]; P < 0.001), and significantly improved SGRQ and CAT versus TIO. Treatment safety profiles were similar. Once-daily single-inhaler FF/UMEC/VI significantly improved lung function and health status versus once-daily TIO in symptomatic moderate-to-very-severe COPD patients, with a similar safety profile.

Details

Title
Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD
Author
Bansal Sandeep 1 ; Anderson, Martin 2 ; Anzueto Antonio 3 ; Brown, Nicola 4 ; Compton, Chris 5 ; Corbridge, Thomas C 6 ; Erb, David 7 ; Harvey, Catherine 4 ; Kaisermann, Morrys C 8 ; Mitchell, Kaye 9 ; Lipson, David A 10   VIAFID ORCID Logo  ; Martin, Neil 11 ; Chang-Qing, Zhu 4 ; Papi, Alberto 12   VIAFID ORCID Logo 

1  Penn Highlands Healthcare, The Lung Center, Du Bois, USA (GRID:grid.428754.8) (ISNI:0000 0004 4659 5935) 
2  Karolinska Institutet, Stockholm, Sweden (GRID:grid.4714.6) (ISNI:0000 0004 1937 0626) 
3  The University of Texas Health Science Center, Division of Pulmonary Diseases and Critical Care Medicine, School of Medicine, San Antonio, USA (GRID:grid.468222.8); South Texas Veterans Health Care System, Audie L. Murphy Memorial VA Hospital, San Antonio, USA (GRID:grid.280682.6) (ISNI:0000 0004 0420 5695) 
4  Iron Bridge Road North, GSK, Stockley Park West, West Drayton, Uxbridge, UK (GRID:grid.418236.a) (ISNI:0000 0001 2162 0389) 
5  GSK, Brentford, UK (GRID:grid.418236.a) (ISNI:0000 0001 2162 0389) 
6  GSK, Research Triangle Park, USA (GRID:grid.418019.5) (ISNI:0000 0004 0393 4335); Northwestern University, Feinberg School of Medicine, Chicago, USA (GRID:grid.16753.36) (ISNI:0000 0001 2299 3507) 
7  VitaLink Research Gaffney, Gaffney, USA (GRID:grid.16753.36) 
8  GSK, Collegeville, USA (GRID:grid.418019.5) (ISNI:0000 0004 0393 4335) 
9  Minnesota Lung Center, Minneapolis, USA (GRID:grid.418019.5) 
10  GSK, Collegeville, USA (GRID:grid.418019.5) (ISNI:0000 0004 0393 4335); University of Pennsylvania, Perelman School of Medicine, Philadelphia, USA (GRID:grid.25879.31) (ISNI:0000 0004 1936 8972) 
11  GSK, Brentford, UK (GRID:grid.418236.a) (ISNI:0000 0001 2162 0389); University of Leicester, Leicester, UK (GRID:grid.9918.9) (ISNI:0000 0004 1936 8411) 
12  University of Ferrara, Respiratory Unit, Department of Morphology, Surgery and Experimental Medicine, Ferrara, Italy (GRID:grid.8484.0) (ISNI:0000 0004 1757 2064) 
Publication year
2021
Publication date
2021
Publisher
Nature Publishing Group
e-ISSN
20551010
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1038/s41533-021-00241-z
ProQuest document ID
2531840353
Copyright
© The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.