Conditions: COPD Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 641
Healthy volunteers: no

Brief summary:
This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.

Detailed description:
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in approximately 645 subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.

SUN-101 or placebo will be administered twice daily as an oral inhalation using the investigational eFlow CS nebulizer.

Arms:
arm 1: SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer arm 2: SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer arm 3: Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Interventions: intervention 1: SUN-101 50 mcg BID eFlow (CS) nebulizer intervention 2: SUN-101 25 mcg BID eFlow (CS) nebulizer intervention 3: Placebo eFlow (CS) nebulizer
Intervention descriptions: intervention 1: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer intervention 2: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer intervention 3: Placebo BID eFlow (R) Closed System (CS) nebulizer

Protocol document: