Phase 2
Completed N=139
Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study
Source: ClinicalTrials.gov NCT01426009 ↗Enrolled (actual)
139
Serious AEs
13.4%
Results posted
May 2018
Primary outcomePrimary: Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1) — 0.0477; 0.1009; 0.0648; 0.0632 liters — p=0.0003
Summary
The purpose of this study is to determine steady-state efficacy and dose response profile and to assess safety and pharmacokinetic profile of nebulized EP-101(SUN101) after 7-day dosing using an investigational high efficiency nebulizer (eFlow®) compared with placebo and two active comparators in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1) |
0.0477; 0.1009; 0.0648; 0.0632; 0.0933; 0.0740 | 0.0003 sig |
| PRIMARY Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7 |
0.1001; 0.1520; 0.1414; 0.1720; 0.1990; 0.1213 | <0.0001 sig |
| SECONDARY Peak FEV1 (Maximum FEV1 During the First 4 Hours Post-dose on Day 1 and Day 7) |
1.469; 1.498; 1.443; 1.455; 1.601; 1.434 | — |
| SECONDARY Treatment Responders (Number of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7) |
18; 29; 24; 24; 24; 26 | — |
| SECONDARY Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests |
23; 23; 28; 26; 19; 12 | — |
| SECONDARY Rescue Medication Use |
1.34; 1.11; 1.48; 1.29; 1.42; 1.33 | — |
| SECONDARY Treatment Responders (Percentage of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7) |
25.0; 38.7; 32.0; 35.3; 33.8; 34.7 | — |
Eligibility Criteria
Inclusion Criteria
- 40-75 years of age
- Clinical diagnosis of moderate to severe COPD
- Current/ex-smokers with at least 10 pack-year smoking history
- Post-bronchodilator FEV1 ≥ 30% and ≤ 70% predicted normal values
- Post-bronchodilator FEV1/FVC ratio of ≤ 0.70
- Post-bronchodilator improvement in FEV1 ≥ 12% and ≤ 30%, and a minimum of 100 mL
- Willing and able to remain at the study site for at least 24 hours at each study visit
- Signed written informed consent
Exclusion Criteria
- Current evidence or recent history of any clinically significant and unstable disease or abnormality (e.g., myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes)
- Primary diagnosis of asthma
- History of malignancy within the past 5 years
- History of COPD exacerbation within 6 weeks of Screening
- Daily oxygen therapy > 10 hours per day
- Systemic steroids use within 6 weeks of Screening
- Respiratory tract infection within 6 weeks of Screening
- History of tuberculosis, bronchiectasis
- History of urinary retention or bladder neck obstruction type symptoms
- History of glaucoma
- Prolonged QTc interval (>460msec) or history of long QT syndrome
- Recent history of alcohol or drug abuse
- Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable birth control methods
- History of hypersensitivity or intolerance to aerosol medications
- Participation in another investigational drug study within 30 days of Screening
Data sourced from ClinicalTrials.gov (NCT01426009). 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.