Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter, Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-5 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)
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).
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).
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