Once-Daily Triple Therapy in Patients with Advanced COPD: Healthcare Resource Utilization Data and Associated Costs from the FULFIL Trial

Adv Ther. 2017 Sep;34(9):2163-2172. doi: 10.1007/s12325-017-0604-x. Epub 2017 Sep 5.


Introduction: Chronic obstructive pulmonary disease is associated with a high healthcare resource and cost burden. Healthcare resource utilization was analyzed in patients with symptomatic chronic obstructive pulmonary disease at risk of exacerbations in the FULFIL study. Patients received either once-daily, single inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol) 100 µg/62.5 µg/25 µg or twice-daily dual inhaled corticosteroid/long-acting beta agonist therapy (budesonide/formoterol) 400 µg/12 µg.

Methods: FULFIL was a phase III, randomized, double-blind, double-dummy, multicenter study. Unscheduled contacts with healthcare providers were recorded by patients in a daily electronic diary; the costs of healthcare resource utilization were calculated post hoc using UK reference costs.

Results: Over 24 weeks, slightly fewer patients who received fluticasone furoate/umeclidinium/vilanterol (169/911; 18.6%) required contacts with healthcare providers compared with budesonide/formoterol (180/899; 20.0%). Over 52 weeks in an extension population, fewer patients who received fluticasone furoate/umeclidinium/vilanterol required unscheduled contacts with healthcare providers compared with budesonide/formoterol (25.2% vs. 32.7%). Non-drug costs per treated patient per year were lower in the fluticasone furoate/umeclidinium/vilanterol group than the budesonide/formoterol group over 24 and 52 weeks (£653.80 vs. £763.32 and £749.22 vs. £988.03, respectively), with the total annualized cost over 24 weeks being slightly greater for fluticasone furoate/umeclidinium/vilanterol than budesonide/formoterol (£1,289.35 vs. £1,267.45).

Conclusions: This healthcare resource utilization evidence suggests that, in a clinical trial setting over a 24- or 52-week timeframe, non-drug costs associated with management of a single inhaler fluticasone furoate/umeclidinium/vilanterol are lower compared with twice-daily budesonide/formoterol.

Trial registration: ClinicalTrials.gov number: NCT02345161.

Funding: GSK.

Keywords: Budesonide/formoterol; COPD burden; Cost analyses; Fluticasone furoate/umeclidinium/vilanterol; Randomized controlled trials; Single inhaler triple therapy; Trial-based healthcare resource utilization.

MeSH terms

  • Adrenal Cortex Hormones / economics
  • Adrenal Cortex Hormones / therapeutic use
  • Adult
  • Aged
  • Aged, 80 and over
  • Androstadienes / economics
  • Androstadienes / therapeutic use
  • Bronchodilator Agents / economics*
  • Bronchodilator Agents / therapeutic use*
  • Budesonide / economics
  • Budesonide / therapeutic use
  • Double-Blind Method
  • Female
  • Formoterol Fumarate / economics
  • Formoterol Fumarate / therapeutic use
  • Humans
  • Male
  • Middle Aged
  • Nebulizers and Vaporizers / economics*
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Pulmonary Disease, Chronic Obstructive / economics*
  • United Kingdom


  • Adrenal Cortex Hormones
  • Androstadienes
  • Bronchodilator Agents
  • Budesonide
  • fluticasone furoate
  • Formoterol Fumarate

Associated data

  • ClinicalTrials.gov/NCT02345161