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A Phase III, 24 week, randomized, double blind, double dummy, parallel group study (with an extension to 52 weeks in a subset of subjects) comparing the efficacy, safety and tolerability of the fixed dose triple combination FF/UMEC/VI administered once-daily in the morning via a dry powder inhaler with budesonide/formoterol 400mcg/12mcg administered twice-daily via a reservoir inhaler in subjects with chronic obstructive pulmonary disease

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Trial Profile

A Phase III, 24 week, randomized, double blind, double dummy, parallel group study (with an extension to 52 weeks in a subset of subjects) comparing the efficacy, safety and tolerability of the fixed dose triple combination FF/UMEC/VI administered once-daily in the morning via a dry powder inhaler with budesonide/formoterol 400mcg/12mcg administered twice-daily via a reservoir inhaler in subjects with chronic obstructive pulmonary disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Aug 2023

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At a glance

  • Drugs Fluticasone furoate/umeclidinium/vilanterol (Primary) ; Salbutamol sulfate (Primary) ; Budesonide/formoterol
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms FULFIL
  • Sponsors GlaxoSmithKline; GSK

Most Recent Events

  • 01 Aug 2022 Results assessing non-linear mixed effect (NLME) model-based analysis may improve confidence in a Phase III trial through more precise estimates of the drug effect, published in the Pharmaceutical Research.
  • 03 Oct 2020 Results of prespecified subgroup analysis of 24 hours serial spirometriic assessment along with a post hoc analysis evaluated serial spirometry by disease severity at screening, published in the Advances in Therapy
  • 19 Jul 2019 Results of population pharmacokinetic analysis of pooled data from three studies(NCT02345161, NCT02164513 and NCT02729051) published in the Clinical Pharmacokinetics

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