NCT02347761

Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 653 (actual)
• Sponsor: Sunovion Respiratory Development Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.

Detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in approximately 645 subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines. SUN-101 or placebo will be administered twice daily as an oral inhalation using the investigational eFlow CS nebulizer. Approximately 150 subjects will be enrolled in the substudy (at selected sites only). These subjects will be required to participate in serial spirometry, vital signs, ECGs, and an additional Holter monitor assessment at Visit 6 (Week 12). This subset of subjects will be referred to as the Substudy Population.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	SUN-101 50 mcg BID eFlow (CS) nebulizer	SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
DRUG	SUN-101 25 mcg BID eFlow (CS) nebulizer	SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
DRUG	Placebo BID eFlow Closed System (CS) nebulizer	Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-01-27
• Last updated: 2018-03-22
• Results posted: 2018-03-22

Locations

44 sites across 1 country: United States