At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 275 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
EP-101 12.5 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of EP-101 (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease: GOLDEN-2 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)
In Brief
A Phase 2 clinical trial evaluating Placebo, EP-101 12.5 mcg, and 3 other interventions for COPD. Completed, enrolled 275 participants across 26 sites.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedOct 2012
Primary CompletionApr 2013
TodayJul 2026
First PostedOct 15, 2012
Enrollment StartOct 1, 2012
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.7 years ago
Interventions
Placebodrug
EP-101 Placebo AM + EP-101 Placebo PM
EP-101 12.5 mcgdrug
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 25 mcgdrug
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 50 mcgdrug
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 100 mcgdrug
EP-101 100 mcg AM + EP-101 100 mcg PM