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: 19 Jul 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

    • 19 Jul 2017 Results (n=1294) from GOLDEN-3 and GOLDEN-4 studies assessing the efficacy and safety of nebulized glycopyrrolate in subjects with moderate-to-very-severe COPD and several characteristics representative of the general COPD population, published in the Respiratory Medicine.
    • 26 May 2017 According to a Sunovion Pharmaceuticals media release, the US FDA has issued a Complete Response Letter (CRL) for the NDA for SUN-101/eFlow. The CRL does not require Sunovion to conduct any additional clinical studies for the approval of SUN-101/eFlow.
    • 24 May 2017 Results of a pooled analysis assessing Health-Related Quality of Life in patients from phase III GOLDEN studies (GOLDEN 3, 4 and 5; n=2379), presented at the 113th International Conference of the American Thoracic Society
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