Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4)
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.
Timeline
- Start
- 2015-02
- Primary completion
- 2015-12
- Completion
- 2015-12
Outcome
Met primary endpoint
registry analysis (superiority test); SUN-101 50 mcg BID eFlow (CS) Nebulizer vs Placebo BID Eflow (CS) Nebulizer; p = 0.0002; Least Mean Squared (SE) 0.0736 (95% CI 0.0346 to 0.1127); NCT02347774 ↗
registry analysis (superiority test); SUN-101 25 mcg BID e-Flow (CS) Nebulizer vs Placebo BID Eflow (CS) Nebulizer; p = 0.0001; Least Mean Squared (SE) 0.0810 (95% CI 0.0416 to 0.1204); NCT02347774 ↗
registry analysis (superiority test); SUN-101 50 mcg BID eFlow (CS) Nebulizer vs Placebo BID Eflow (CS) Nebulizer; p <0.0001; Least Mean Squared (SE) 0.0820 (95% CI 0.0417 to 0.1224); NCT02347774 ↗
registry analysis (superiority test); SUN-101 25 mcg BID e-Flow (CS) Nebulizer vs Placebo BID Eflow (CS) Nebulizer; p = 0.0001; Least Mean Squared (SE) 0.0840 (95% CI 0.0433 to 0.1246); NCT02347774 ↗
Publications
- Results Kerwin E, Donohue JF, Goodin T, Tosiello R, Wheeler A, Ferguson GT. Efficacy and safety of glycopyrrolate/eFlow(R) CS (nebulized glycopyrrolate) in moderate-to-very-severe COPD: Results from the glycopyrrolate for obstructive lung disease via electronic nebulizer (GOLDEN) 3 and 4 randomized controlled trials. Respir Med. 2017 Nov;132:238-250. doi: 10.1016/j.rmed.2017.07.011. Epub 2017 Jul 19.
- Ohar J, Tosiello R, Goodin T, Sanjar S. Efficacy and safety of a novel, nebulized glycopyrrolate for the treatment of COPD: effect of baseline disease severity and age; pooled analysis of GOLDEN 3 and GOLDEN 4. Int J Chron Obstruct Pulmon Dis. 2018 Dec 18;14:27-37. doi: 10.2147/COPD.S184808. eCollection 2019.
- Ferguson GT, Kerwin EM, Donohue JF, Ganapathy V, Tosiello RL, Bollu VK, Rajagopalan K. Health-Related Quality of Life Improvements in Moderate to Very Severe Chronic Obstructive Pulmonary Disease Patients on Nebulized Glycopyrrolate: Evidence from the GOLDEN Studies. Chronic Obstr Pulm Dis. 2018 Jun 6;5(3):193-207. doi: 10.15326/jcopdf.5.3.2017.0178.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IVOSPEMIN | Other / unclassified | 25 ug | Inhaled |
| Subject | IVOSPEMIN | Other / unclassified | 50 ug | Inhaled |