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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jun 2023

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At a glance

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

    • Most Recent Events

    • 29 Jun 2019 Results of post hoc analysis of exploratory genome-wide genetic analysis from 10 trials (NCT01772134, NCT01772147, NCT00633217, NCT01817764, NCT01879410, NCT01822899, NCT01323621, NCT01342913, NCT01323634, and NCT01706328)published in the Respiratory Medicine
    • 06 Sep 2018 Results (n=1637) of integrated post-hoc analysis of 4 trials (NCT01772134, NCT01772147, NCT01957163, NCT02119286) published in the Advances in Therapy
    • 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
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