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A Phase IIb, Randomized (Stratified), Double-Blind (Sponsor Open), Parallel-Group, Placebo-Controlled, Dose-Finding Study of Nemiralisib (GSK2269557) Added to Standard of Care (SoC) Versus SoC Alone in Participants Diagnosed With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

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Trial Profile

A Phase IIb, Randomized (Stratified), Double-Blind (Sponsor Open), Parallel-Group, Placebo-Controlled, Dose-Finding Study of Nemiralisib (GSK2269557) Added to Standard of Care (SoC) Versus SoC Alone in Participants Diagnosed With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 09 Jul 2022

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At a glance

  • Drugs Nemiralisib (Primary) ; Antibacterials; Prednisone; Salbutamol
  • Indications Chronic obstructive pulmonary disease
  • Focus Therapeutic Use
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK

    • Most Recent Events

    • 03 Jun 2021 Primary endpoint of Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 84 Measured Post Bronchodilator has not been met, according to results published in the Internet Document (International Journal of Chronic Obstructive Pulmonary Disease).
    • 03 Jun 2021 Results published in the Internet Document (International Journal of Chronic Obstructive Pulmonary Disease).
    • 03 Jun 2021 According results published in the Internet Document (International Journal of Chronic Obstructive Pulmonary Disease), in July 2018, recruitment was temporary halted and in Dec 2018, after review of the results of the third planned interim analysis the recruitment was not re-opened and study was terminated.
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