Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD

Sandeep Bansal; Martin Anderson; Antonio Anzueto; Nicola Brown; Chris Compton; Thomas C Corbridge; David Erb; Catherine Harvey; Morrys C Kaisermann; Mitchell Kaye; David A Lipson; Neil Martin; Chang-Qing Zhu; Alberto Papi

doi:10.1038/s41533-021-00241-z

Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD

NPJ Prim Care Respir Med. 2021 May 25;31(1):29. doi: 10.1038/s41533-021-00241-z.

Authors

Sandeep Bansal¹, Martin Anderson², Antonio Anzueto^{3

4}, Nicola Brown⁵, Chris Compton⁶, Thomas C Corbridge^{7

8}, David Erb⁹, Catherine Harvey⁵, Morrys C Kaisermann¹⁰, Mitchell Kaye¹¹, David A Lipson^{10

12}, Neil Martin^{6

13}, Chang-Qing Zhu⁵, Alberto Papi¹⁴

Affiliations

¹ The Lung Center, Penn Highlands Healthcare, Du Bois, PA, USA.
² Karolinska Institutet, Stockholm, Sweden.
³ Division of Pulmonary Diseases and Critical Care Medicine, School of Medicine, The University of Texas Health Science Center, San Antonio, TX, USA.
⁴ Audie L. Murphy Memorial VA Hospital, South Texas Veterans Health Care System, San Antonio, TX, USA.
⁵ GSK, Stockley Park West, Iron Bridge Road North, West Drayton, Uxbridge, Middlesex, UK.
⁶ GSK, Brentford, Middlesex, UK.
⁷ GSK, Research Triangle Park, NC, USA.
⁸ Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
⁹ VitaLink Research Gaffney, Gaffney, SC, USA.
¹⁰ GSK, Collegeville, PA, USA.
¹¹ Minnesota Lung Center, Minneapolis, MN, USA.
¹² Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
¹³ University of Leicester, Leicester, Leicestershire, UK.
¹⁴ Respiratory Unit, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, FE, Italy. ppa@unife.it.

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.

Trial registration: ClinicalTrials.gov NCT03474081.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Administration, Inhalation
Androstadienes
Benzyl Alcohols
Bronchodilator Agents* / therapeutic use
Chlorobenzenes
Double-Blind Method
Forced Expiratory Volume
Humans
Nebulizers and Vaporizers
Pulmonary Disease, Chronic Obstructive* / drug therapy
Quinuclidines
Tiotropium Bromide / therapeutic use
Treatment Outcome

Substances

Androstadienes
Benzyl Alcohols
Bronchodilator Agents
Chlorobenzenes
GSK573719
Quinuclidines
vilanterol
fluticasone furoate
Tiotropium Bromide

Associated data

ClinicalTrials.gov/NCT03474081