Conditions: COPD
Keywords: Chronic Obstructive Pulmonary Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 653
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. Approximately 150 subjects will be enrolled in the substudy (at selected sites only). These subjects will be required to participate in serial spirometry, vital signs, ECGs, and an additional Holter monitor assessment at Visit 6 (Week 12). This subset of subjects will be referred to as the Substudy Population.

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

Protocol document: