Conditions: COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 275
Healthy volunteers: no

Brief 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).

Arms:
arm 1: EP-101 Placebo AM + EP-101 Placebo PM arm 2: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM arm 3: EP-101 25 mcg AM + EP-101 25 mcg PM arm 4: EP-101 50 mcg AM + EP-101 50 mcg PM arm 5: EP-101 100 mcg AM + EP-101 100 mcg PM

Interventions: intervention 1: Placebo intervention 2: EP-101 12.5 mcg intervention 3: EP-101 25 mcg intervention 4: EP-101 50 mcg intervention 5: EP-101 100 mcg
Intervention descriptions: intervention 1: EP-101 Placebo AM + EP-101 Placebo PM intervention 2: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM intervention 3: EP-101 25 mcg AM + EP-101 25 mcg PM intervention 4: EP-101 50 mcg AM + EP-101 50 mcg PM intervention 5: EP-101 100 mcg AM + EP-101 100 mcg PM

Protocol document: