NCT02038829

A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD

A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD: GOLDEN 6 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Sunovion Respiratory Development Inc. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg 2x a day will be given as an active comparator.

Detailed description

This is a randomized, six-way crossover study to determine the efficacy and dose-response profile of SUN101. The study population will consist of subjects 40 to 65 years-old (inclusive), with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg bid will be given as an active comparator. The study will be double-blind for SUN-101 and placebo and will be open-label for aclidinium.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	SUN101 3 mcg	SUN-101 3 mcg bid
DRUG	SUN-101 6.25 mcg	SUN-101 6.25 mcg bid
DRUG	SUN-101 12.5 mcg	SUN-101 12.5 mcg bid
DRUG	SUN-101 50 mcg	SUN-101 50 mcg bid
DRUG	Aclidinium	Aclidinium 400 mcg bid

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-01-17
• Last updated: 2018-04-10
• Results posted: 2018-01-25

Locations

10 sites across 1 country: United States