Phase 3
Completed N=641
Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4)
Source: ClinicalTrials.gov NCT02347774 ↗Enrolled (actual)
641
Serious AEs
4.1%
Results posted
Mar 2018
Primary outcomePrimary: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 — 0.0847; 0.0921; 0.0111 liters — p=0.0002
◆ Published Evidence
Established
39citations · ~4 / year
Efficacy and safety of glycopyrrolate/eFlow<sup>®</sup> 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.
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.
Linked Publications (3)
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Efficacy and safety of glycopyrrolate/eFlow<sup>®</sup> 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.
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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.
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Health-Related Quality of Life Improvements in Moderate to Very Severe Chronic Obstructive Pulmonary Disease Patients on Nebulized Glycopyrrolate: Evidence from the GOLDEN Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 |
0.0847; 0.0921; 0.0111 | 0.0002 sig |
| PRIMARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12 |
0.0890; 0.0909; 0.0069 | <0.0001 sig |
| SECONDARY Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12 |
0.1090; 0.1346; 0.0156 | — |
| SECONDARY Change From Baseline in Trough Forced Vital Capacity (FVC)Week 12 |
0.1210; 0.1385; 0.0084 | — |
| SECONDARY Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) at Week 12/End of Study |
-3.825; -3.225; -0.138 | — |
| SECONDARY Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) Week 12/End of Study |
-3.609; -3.637; -0.052 | — |
| SECONDARY Change in Number of Rescue Medication Puffs Per Day Over the 12-week Double-blind Treatment Period |
-0.845; -0.959; -0.678 | — |
| SECONDARY Number of Subjects With Treatment Emergent Adverse Events (TEAE) |
114; 101; 111 | — |
| SECONDARY Percentage of Subjects With Treatment Emergent Adverse Events (TEAE) |
53.3; 47.2; 52.4 | — |
| SECONDARY Number of Subjects With Treatment Emergent Serious Adverse Events (SAE) |
8; 5; 13 | — |
| SECONDARY Percentage of Subjects With Treatment Emergent Serious Adverse Events (SAE) |
3.7; 2.3; 6.1 | — |
| SECONDARY Number of Subjects Who Discontinue Treatment Due to TEAE |
9; 15; 19 | — |
| SECONDARY Percentage of Subjects Who Discontinue Treatment Due to TEAE |
4.2; 7.0; 9.0 | — |
| SECONDARY Number of Subjects With Major Adverse Cardiac Events (MACE) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Subjects With Major Adverse Cardiac Events (MACE) |
0; 0; 0.9; 0; 0; 0 | — |
| SECONDARY Incidence Rate Per 1000 Person-years of Subjects With Major Adverse Cardiac Events (MACE) |
64.6; 63.0; 62.2 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients age ≥ 40 years, inclusive
- A clinical diagnosis of COPD according to the GOLD 2014 guidelines
- Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent)
- Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 0.7 L during Screening (Visit 1)
- Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio 12 hours per day
- Respiratory tract infection within 6 weeks prior to Screening (Visit 1)
- Use of oral, intravenous, or intramuscular steroids within 3 months prior to Screening (Visit 1)
- History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin
- Prolonged QTcF (> 450 msec for males and > 470 msec for females) during Screening (Visit 1) as determined from the report provided by the central laboratory, or history of long QT syndrome
- History of or clinically significant on-going bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months
- History of narrow angle glaucoma
- History of hypersensitivity or intolerance to aerosol medications
- Recent documented history (within the previous 3 months) of substance abuse
- Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator
- Participation in another investigational drug study where drug was received within 30 days prior to Screening (Visit 1) or current participation in another investigational drug trial, including a SUN-101 study
- Previously received SUN-101 (active treatment; formerly known as EP-101)
- Contraindicated for treatment with, or having a history of reactions/hypersensitivity to anticholinergic agents, beta2 agonists, or sympathomimetic amines
Data sourced from ClinicalTrials.gov (NCT02347774) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.