Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study

Summary

The purpose of this study is to determine steady-state efficacy and dose response profile and to assess safety and pharmacokinetic profile of nebulized EP-101(SUN101) after 7-day dosing using an investigational high efficiency nebulizer (eFlow®) compared with placebo and two active comparators in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Timeline

Start

2011-08

Primary completion

2011-12

Completion

2011-12

Outcome

Met primary endpoint

registry EP-101 Via Nebulizer (eFlow®) 25 mcg vs Placebo; p = 0.0003; Least Squares Mean Difference (SE) 0.0723 (95% CI 0.0347 to 0.1099) NCT01426009 ↗

registry EP-101 Via Nebulizer (eFlow®) 25 mcg vs Placebo; p <0.0001; Least Squares Mean Difference (SE) 0.0767 (95% CI 0.0505 to 0.1028) NCT01426009 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EP-101	Unknown	25 ug	Inhaled
Subject	EP-101	Unknown	50 ug	Inhaled
Subject	EP-101	Unknown	100 ug	Inhaled
Subject	EP-101	Unknown	200 ug	Inhaled
Comparator	Ipratropium	Small molecule	500 ug	Inhaled
Comparator	Tiotropium	Other / unclassified	18 ug	Inhaled

Indications