Fluticasone Furoate/Umeclidinium/Vilanterol Therapy and COPD Exacerbations

Which therapy more effectively reduces severe COPD exacerbations: once-daily FF/UMEC/VI or twice-daily ICS/LABA?

The following article is a part of conference coverage from CHEST 2021, being held virtually from October 17 to October 20, 2021. The team at Pulmonology Advisor will be reporting on the latest news and research conducted by leading experts in the field. Check back for more from CHEST 2021.


Treatment with once-daily single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy appears to be more efficacious in reducing severe exacerbations in patients with chronic obstructive pulmonary disease (COPD) than twice-daily inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) dual therapy. This was among the findings of a post-hoc analysis of the FULFIL trial (ClinicalTrials.gov Identifier: NCT02345161) presented at the CHEST Annual Meeting, held virtually October 17 to 20.

The FULFIL trial is a phase 3, randomized, double-blind trial that demonstrated clinically meaningful and statistically significant improvements in lung function and health-related quality of life as well as reductions in moderate/severe exacerbation annualized rates in patients with symptomatic COPD. The study compared once-daily FF/UMEC/VI triple therapy with twice-daily budesonide/formoterol (BUD/FOR) ICS/LABA dual therapy in patients at risk for COPD exacerbations.

Because severe exacerbations can create a high clinical and financial burden on both patients and health care systems, researchers performed a post hoc analysis of the FULFIL study to examine treatment effects on severe exacerbation rates. They found that 1% of patients on FF/UMEC/VI and 2% of patients on BUD/FOR experienced severe exacerbations up to week 24, which increased to 2% and 9%, respectively, up to week 52. In addition, FF/UMEC/VI reduced severe exacerbation rates compared with BUD/FOR by 51% (mean annualized rate 0.029 vs 0.059, respectively; rate ratio: 0.49; P =.061) up to week 24, and by 67% (mean annualized rate 0.037 vs 0.112, respectively; rate ratio: 0.33; P =.021) up to week 52.

“These results highlight the potential benefits of once-daily single-inhaler FF/UMEC/VI triple therapy over twice-daily ICS/LABA dual therapy in reducing the clinical and economic burden caused by severe exacerbations in this patient population,” concluded the investigators.

Disclosure: This research was supported by GlaxoSmithKline. Please see the original reference for a full list of disclosures.


Panettieri R, Bangalore M, Camargo C, et al. Effect of once-daily single-inhaler fluticasone furoate/umeclidinium/vilanterol triple therapy on severe exacerbation rates compared with twice-daily budesonide/formoterol dual therapy in patients with COPD: a post hoc analysis of the FULFIL study. Presented at: CHEST 2021; October 17-20, 2021; Orlando, FL/Virtual. Abstract A1818-A1821.