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

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Sep 2016

At a glance

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

    • 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
    • 23 Jun 2015 Status changed from active, no longer recruiting to completed as per ClinicalTrials.gov record.
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