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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.

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: 19 Jul 2019

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At a glance

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

    • 19 Jul 2019 Results of population pharmacokinetic analysis of pooled data from three studies(NCT02345161, NCT02164513 and NCT02729051) published in the Clinical Pharmacokinetics
    • 23 May 2018 Results of population pharmacokinetic analysis from NCT02164513, NCT02345161 and NCT02729051 studies presented at the 114th International Conference of the American Thoracic Society.
    • 15 May 2018 Results (n=74) of a population pharmacokinetic analysis in a subset of patients from this study, published in the Journal of Clinical Pharmacology.
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