npj Primary Care Respiratory Medicine (May 2021)

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
https://doi.org/10.1038/s41533-021-00241-z
Journal volume & issue
Vol. 31, no. 1
pp. 1 – 9

Abstract

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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.