NCT02276222

A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD

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: Phase 3
• Study type: Interventional
• Enrollment: 1,087 (actual)
• Sponsor: Sunovion Respiratory Development Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week, open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a day or Spiriva® \[tiotropium\] given as 18 mcg once a day).

Detailed description

This is a Phase 3, randomized, open-label, active-controlled, parallel-group, multicenter, long-term safety trial of 48 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer or Spiriva in approximately 1050 subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines. Eligible subjects will enter the 48-week, open-label treatment period following randomization to receive one of two treatments (SUN-101 given as 50 mcg BID or Spiriva® \[tiotropium\] given as 18 mcg QD). The hypothesis for this study is that the incidence of treatment-emergent adverse events reported over the course of 48 weeks of treatment by subjects randomized to SUN-101 is numerically similar to the incidence of treatment-emergent adverse events reported over the course of 48 weeks of treatment by subject randomized to Spiriva (tiotropium).

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	SUN-101 50 mcg BID eFlow (CS) nebulizer	SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
DRUG	Spiriva® 18 mcg QD Handihaler	Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-10-28
• Last updated: 2018-03-13
• Results posted: 2018-03-13

Locations

118 sites across 4 countries: United States, Czechia, Hungary, Russia