TY - JOUR
T1 - Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD
AU - Bansal, Sandeep
AU - Anderson, Martin
AU - Anzueto, Antonio
AU - Brown, Nicola
AU - Compton, Chris
AU - Corbridge, Thomas C.
AU - Erb, David
AU - Harvey, Catherine
AU - Kaisermann, Morrys C.
AU - Kaye, Mitchell
AU - Lipson, David A.
AU - Martin, Neil
AU - Zhu, Chang Qing
AU - Papi, Alberto
N1 - Funding Information:
This study was funded by GlaxoSmithKline (GSK study 207626; NCT03474081). The funders of the study had a role in the study design, data analysis, data interpretation, and writing of the report. Editorial support (in the form of writing assistance, assembling figures, collating author comments, grammatical editing, and referencing) was provided by Anne Errichelli, DPhil, at Fishawack Indicia Ltd, UK, and was funded by GSK. ELLIPTA is owned by or licensed to the GSK Group of Companies. HandiHaler is a trademark of Boehringer Ingelheim International GmbH.
Funding Information:
S.B. has received speaker fees from GSK, Boehringer Ingelheim, Auris Health, Veran, Veracyte, Biodesix, Pinnacle Biologics, and Circulogene. He has also previously participated in speaker’s bureau for Sunovion Pharmaceuticals and holds stocks/ shares in Veracyte. M.A. has received speaker fees from AstraZeneca, Boehringer Ingelheim, GSK, MEDA, Orion Pharma, and TEVA. A.A. has received consultancy fees from Boehringer Ingelheim, Novartis, AstraZeneca, and Theravance Mylan. N.B., C.C., T.C.C., C.H., M.C.K., D.A.L., N.M., and C.-Q.Z. are employees of GSK and own stocks/ shares. D.E. has received compensation for being a trial investigator for Vitalink Research. M.K. has nothing to disclose. A.P. has received consultancy fees and board membership from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Mundipharma, and TEVA, and consultancy fees and payment for lectures from Sanofi. He has also received reimbursement of travel expenses from Avillion, reimbursement of travel expenses and payment for lectures from AstraZeneca, Boehringer Ingelheim, Chiesi, ELPEN Pharmaceutical, GSK, Menarini, MSD, Mundipharma, Novartis, TEVA, and Zambon, and research grants from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Pfizer, Sanofi, and TEVA.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
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U2 - 10.1038/s41533-021-00241-z
DO - 10.1038/s41533-021-00241-z
M3 - Article
C2 - 34035312
AN - SCOPUS:85106921733
SN - 2055-1010
VL - 31
JO - npj Primary Care Respiratory Medicine
JF - npj Primary Care Respiratory Medicine
IS - 1
M1 - 29
ER -