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A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort Turbuhaler, as an Active Control, on Lung Function Over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD

Trial Profile

A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort Turbuhaler, as an Active Control, on Lung Function Over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Budesonide/formoterol (Primary) ; Budesonide; Formoterol
  • Indications Chronic obstructive pulmonary disease
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms TELOS
  • Sponsors AstraZeneca AB; Pearl Therapeutics
  • Most Recent Events

    • 16 Sep 2018 Primary endpoint has been met. (Change from baseline in FEV1 AUC 0-4), according to an AstraZeneca media release.
    • 16 Sep 2018 According to an AstraZeneca media release, data from the study were presented at the European Respiratory Society (ERS) International Congress 2018 and published in the European Respiratory Journal.
    • 16 Sep 2018 Results presented in an AstraZeneca media release.

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