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A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva Handihaler as an Active Control

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Trial Profile

A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva Handihaler as an Active Control

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jan 2019

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At a glance

  • Drugs Formoterol (Primary) ; Formoterol/glycopyrrolate (Primary) ; Glycopyrrolate (Primary) ; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms PINNACLE-3
  • Sponsors Pearl Therapeutics

    • Most Recent Events

    • 08 Jan 2020 The Form of the given drugs ( Formoterol, Formoterol/glycopyrrolate, Glycopyrrolate ) are assumed from the PINNACLE-4 study.
    • 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).
    • 19 Oct 2018 According to an AstraZeneca media release, based on the Phase III PINNACLE programme, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the marketing authorisation for 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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