drugset / Trial / NCT01426009

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

NCT01426009

Phase 2 Completed 140 enrolled Sunovion Respiratory Development Inc.
RandomizedCrossoverQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
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