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 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.

• Authors: 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
• Journal: NPJ primary care respiratory medicine (NPJ Prim Care Respir Med) Vol. 31 Issue 1 Pg. 29 (05 25 2021) ISSN: 2055-1010 [Electronic] England
• PMID: 34035312 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

• 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