Trials / Completed
CompletedNCT02347774
Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-4 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 641 (actual)
- Sponsor
- Sunovion Respiratory Development Inc. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SUN-101 50 mcg BID eFlow (CS) nebulizer | SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer |
| DRUG | SUN-101 25 mcg BID eFlow (CS) nebulizer | SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer |
| DRUG | Placebo eFlow (CS) nebulizer | Placebo BID eFlow (R) Closed System (CS) nebulizer |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2015-01-27
- Last updated
- 2018-03-13
- Results posted
- 2018-03-13
Locations
45 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02347774. Inclusion in this directory is not an endorsement.