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A Randomized, Double Blind, Chronic Dosing, 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 and Spiriva Handihaler (Tiotropium Bromide 18 mcg Open-Label) as an Active Control

Trial Profile

A Randomized, Double Blind, Chronic Dosing, 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 and Spiriva Handihaler (Tiotropium Bromide 18 mcg Open-Label) as an Active Control

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Dec 2018

At a glance

  • Drugs Formoterol (Primary) ; Formoterol/glycopyrrolate (Primary) ; Glycopyrrolate (Primary) ; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms PINNACLE 1
  • Sponsors Pearl Therapeutics
  • Most Recent Events

    • 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).
    • 15 Jul 2017 Results of post-hoc analysis assessing the impact of baseline symptom score on benefits of Glycopyrrolate/Formoterol using pooled data (n=3699) from PINNACLE-1 and PINNACLE-2 studies, published in the Chest Journal.
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