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Study DB2116961, a multicentre, randomised, blinded, parallel group study to compare UMEC/VI (Umeclidinium/Vilanterol) in a fixed dose combination with Indacaterol plus Tiotropium in symptomatic subjects with moderate to very severe COPD

Trial Profile

Study DB2116961, a multicentre, randomised, blinded, parallel group study to compare UMEC/VI (Umeclidinium/Vilanterol) in a fixed dose combination with Indacaterol plus Tiotropium in symptomatic subjects with moderate to very severe COPD

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Jul 2019

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At a glance

  • Drugs Umeclidinium/vilanterol (Primary) ; Indacaterol; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development
  • Most Recent Events

    • 30 Jun 2019 Trial has been completed in Romania, according to European Clinical Trials Database record.
    • 30 Mar 2016 Primary endpoint has been met. (Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Treatment Day 85 (Visit 8)) as per the results published in the Drugs in R and D.
    • 30 Mar 2016 Results published in the Drugs in R and D
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