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

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 ti...

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Autores principales: 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
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Publicado: Nature Portfolio 2021
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Acceso en línea:https://doaj.org/article/dac6017c105b4a2b8e947907b8317115
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spelling oai:doaj.org-article:dac6017c105b4a2b8e947907b83171152021-12-02T14:49:24ZSingle-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD10.1038/s41533-021-00241-z2055-1010https://doaj.org/article/dac6017c105b4a2b8e947907b83171152021-05-01T00:00:00Zhttps://doi.org/10.1038/s41533-021-00241-zhttps://doaj.org/toc/2055-1010Abstract 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.Sandeep BansalMartin AndersonAntonio AnzuetoNicola BrownChris ComptonThomas C. CorbridgeDavid ErbCatherine HarveyMorrys C. KaisermannMitchell KayeDavid A. LipsonNeil MartinChang-Qing ZhuAlberto PapiNature PortfolioarticleDiseases of the respiratory systemRC705-779ENnpj Primary Care Respiratory Medicine, Vol 31, Iss 1, Pp 1-9 (2021)
institution DOAJ
collection DOAJ
language EN
topic Diseases of the respiratory system
RC705-779
spellingShingle Diseases of the respiratory system
RC705-779
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
Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD
description 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.
format article
author 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
author_facet 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
author_sort Sandeep Bansal
title Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD
title_short Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD
title_full Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD
title_fullStr Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD
title_full_unstemmed Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD
title_sort single-inhaler fluticasone furoate/umeclidinium/vilanterol (ff/umec/vi) triple therapy versus tiotropium monotherapy in patients with copd
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/dac6017c105b4a2b8e947907b8317115
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