Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-3 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

Trial Profile

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-3 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Dec 2017

At a glance

  • Drugs Glycopyrrolate (Primary)
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms GOLDEN-3
  • Sponsors Sunovion Respiratory Development
  • Most Recent Events

    • 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 Results of pooled analysis from of the GOLDEN-3, GOLDEN-4 and GOLDEN-5 studies presented in a Sunovion Pharmaceuticals media release.
    • 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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