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A Randomized, Double-Blind, Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo (PT003014)

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Trial Profile

A Randomized, Double-Blind, Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo (PT003014)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 May 2020

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At a glance

  • Drugs Formoterol (Primary) ; Formoterol/glycopyrrolate (Primary) ; Glycopyrrolate (Primary)
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms PINNACLE 4
  • Sponsors Pearl Therapeutics

    • Most Recent Events

    • 18 May 2020 According to an AstraZeneca media release, results from this trial were published in the International Journal of Chronic Obstructive Pulmonary Disease.
    • 18 May 2020 According to an AstraZeneca media release, the National Medical Products Administration (NMPA) has approved Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in China as a maintenance treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, based on the data from this trial.
    • 20 Dec 2018 According to an AstraZeneca media release, based on the Phase III PINNACLE programme, the European Commission (EC) has approved Bevespi Aerosphere(glycopyrronium/formoterol fumarate) in a pressurised metered-dose inhaler (pMDI) as a maintenance dual bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
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