Phase 3
Completed N=1,087
A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD
Source: ClinicalTrials.gov NCT02276222 ↗Enrolled (actual)
1,087
Serious AEs
11.5%
Results posted
Mar 2018
Primary outcomePrimary: Number of Subjects With Treatment-emergent Adverse Events (TEAE) — 430; 312 participants
◆ Published Evidence
Established
21citations · ~2 / year
Long-term safety of glycopyrrolate/eFlow<sup>®</sup> CS in moderate-to-very-severe COPD: Results from the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) 5 randomized study.
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).
Linked Publications (2)
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Long-term safety of glycopyrrolate/eFlow<sup>®</sup> CS in moderate-to-very-severe COPD: Results from the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) 5 randomized study.
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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 Number of Subjects With Treatment-emergent Adverse Events (TEAE) |
430; 312 | — |
| PRIMARY Percentage of Subjects With Treatment-emergent Adverse Events |
69.4; 67.0 | — |
| PRIMARY Number of Subjects With Treatment-emergent Serious Adverse Events (SAE) |
76; 49 | — |
| PRIMARY Percentage of Subjects With Treatment-emergent Serious Adverse |
12.3; 10.5 | — |
| PRIMARY Number of Subjects Who Discontinue the Study Due to TEAE |
62; 13 | — |
| PRIMARY Percentage of Subjects Who Discontinue the Study Due to TEAE |
10.0; 2.8 | — |
| SECONDARY Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke |
3; 8; 1; 2; 2; 5 | — |
| SECONDARY Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke |
0.5; 1.7; 0.2; 0.4; 0.3; 1.1 | — |
| SECONDARY Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke |
6.4; 20.3; 2.1; 5.1; 4.3; 12.7 | — |
| SECONDARY Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects |
0.1016; 0.0931 | 0.4041 |
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 systemic 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 QTc (> 450 msec for males and > 470 msec for females) during Screening (Visit 1), or history of long QT syndrome.
- History of or clinically significant ongoing 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 (NCT02276222) 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.