Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1087
Healthy volunteers: no

Brief summary:
This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week, open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a day or Spiriva® \[tiotropium\] given as 18 mcg once a day).

Detailed description:
This is a Phase 3, randomized, open-label, active-controlled, parallel-group, multicenter, long-term safety trial of 48 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer or Spiriva in approximately 1050 subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.

Eligible subjects will enter the 48-week, open-label treatment period following randomization to receive one of two treatments (SUN-101 given as 50 mcg BID or Spiriva® \[tiotropium\] given as 18 mcg QD).

The hypothesis for this study is that the incidence of treatment-emergent adverse events reported over the course of 48 weeks of treatment by subjects randomized to SUN-101 is numerically similar to the incidence of treatment-emergent adverse events reported over the course of 48 weeks of treatment by subject randomized to Spiriva (tiotropium).

Arms:
arm 1: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer arm 2: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Interventions: intervention 1: SUN-101 50 mcg BID eFlow (CS) nebulizer intervention 2: Spiriva® 18 mcg QD Handihaler
Intervention descriptions: intervention 1: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer intervention 2: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Protocol document: