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
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
| 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 |