A Multicenter, Randomized, Double-blind, Parallelgroup Study to Evaluate the Efficacy and Safety of the Addition of Umeclidinium Bromide Inhalation Powder (62.5mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily, Umeclidinium Bromide Inhalation Powder (125mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Versus Placebo to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Over 12 Weeks in Subjects With COPD.

Trial Profile

A Multicenter, Randomized, Double-blind, Parallelgroup Study to Evaluate the Efficacy and Safety of the Addition of Umeclidinium Bromide Inhalation Powder (62.5mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily, Umeclidinium Bromide Inhalation Powder (125mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Versus Placebo to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Over 12 Weeks in Subjects With COPD.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 May 2017

At a glance

  • Drugs Umeclidinium (Primary) ; Salmeterol/fluticasone propionate
  • Indications Chronic obstructive pulmonary disease
  • Focus 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
    • 01 Aug 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 03 May 2013 Planned End Date changed from 1 Jan 2014 to 1 Aug 2013 as reported by ClinicalTrials.gov.
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