A Multienter, Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of the Addition of Umeclidinium Bromide (62.5mcg) Once-daily to Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily, Umeclidinium Bromide (125mcg) Once-daily to Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily Versus Placebo to Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily Over 12 Weeks With COPD

Trial Profile

A Multienter, Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of the Addition of Umeclidinium Bromide (62.5mcg) Once-daily to Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily, Umeclidinium Bromide (125mcg) Once-daily to Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily Versus Placebo to Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily Over 12 Weeks With COPD

Completed
Phase of Trial: Phase III

Latest Information Update: 24 May 2017

At a glance

  • Drugs Salmeterol/fluticasone propionate (Primary) ; Umeclidinium (Primary)
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 24 May 2017 Results (n=1637) of pooled post hoc analysis (AC4116135, NCT01772134; AC4116136, NCT01772147; 200109, NCT01957163; and 200110, NCT02119286) presented at the 113th International Conference of the American Thoracic Society
    • 19 May 2014 Primary endpoint 'Forced-expiratory-volume-in-1-second' has been met.
    • 09 Jan 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov..
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