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A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter, Long-Term Safety Trial of Treatment with Nebulized SUN-101 in Patients with COPD: GOLDEN-5 (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer).

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Trial Profile

A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter, Long-Term Safety Trial of Treatment with Nebulized SUN-101 in Patients with COPD: GOLDEN-5 (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer).

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Jul 2018

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At a glance

  • Drugs Glycopyrrolate (Primary) ; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Adverse reactions; Registrational
  • Acronyms GOLDEN-5
  • Sponsors Sunovion Respiratory Development
  • Most Recent Events

    • 23 May 2018 Results of an exploratory analysis presented at the 114th International Conference of the American Thoracic Society.
    • 05 Dec 2017 According to a Sunovion Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Lonhala Magnair (glycopyrrolate) Inhalation Solution (25 mcg twice daily), also known as SUN-101/eFlow, for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
    • 31 Oct 2017 According to a Sunovion Pharmaceuticals media release, results of pooled analysis from of the GOLDEN-3, GOLDEN-4 and GOLDEN-5 studies were presented at the American College of Chest Physicians (CHEST) Annual Meeting 2017.
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