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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 01 May 2017

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

    • 01 May 2017 Primary endpoint (Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks) has been met.
    • 01 May 2017 Results assessing long-term safety and tolerability of GFF MDI, published in the Respiratory Medicine
    • 25 Apr 2016 According to an AstraZeneca media release, the US FDA has approved BEVESPI AEROSPHERE (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
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