Trials / Completed
CompletedNCT01706536
A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 275 (actual)
- Sponsor
- Sunovion Respiratory Development Inc. · Industry
- Sex
- All
- Age
- 35 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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 (GOLD, 2011). The primary analysis will compare each of the EP-101 (SUN101) dose groups to placebo with respect to the change from baseline in morning trough FEV1 on Day 29. Trough FEV1 is defined as the mean of the two FEV1 values obtained at 23 hours 30 minutes and 24 hours after Day 28 AM dose (ie, approximately 12 hours after the previous PM dose).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | EP-101 Placebo AM + EP-101 Placebo PM |
| DRUG | EP-101 12.5 mcg | EP-101 12.5 mcg AM + EP-101 12.5 mcg PM |
| DRUG | EP-101 25 mcg | EP-101 25 mcg AM + EP-101 25 mcg PM |
| DRUG | EP-101 50 mcg | EP-101 50 mcg AM + EP-101 50 mcg PM |
| DRUG | EP-101 100 mcg | EP-101 100 mcg AM + EP-101 100 mcg PM |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2012-10-15
- Last updated
- 2018-03-08
- Results posted
- 2018-03-08
Locations
26 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01706536. Inclusion in this directory is not an endorsement.