Phase 2
N=282
A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
COPD
Bottom Line
View on ClinicalTrials.gov: NCT01706536 ↗Enrolled (actual)
282
Serious AEs
2.1%
Results posted
Mar 2018
Primary outcome: Primary: Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) — 0.0009; 0.1055; 0.1333; 0.1336 liters — p=0.0043
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); EP-101 12.5 mcg (Drug); EP-101 25 mcg (Drug); EP-101 50 mcg (Drug); EP-101 100 mcg (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Sunovion Respiratory Development Inc.
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) |
0.0009; 0.1055; 0.1333; 0.1336; 0.1794 | 0.0043 sig |
| SECONDARY The Standardized Change From Baseline FEV1 AUC(0-12) |
0.0055; 0.1370; 0.1720; 0.1066; 0.1815 | — |
| SECONDARY The Standardized Change From Baseline FEV1 AUC(12-24) |
-0.0725; 0.0578; 0.0563; 0.0692; 0.1284 | — |
| SECONDARY The Peak FEV1 Change From Baseline |
0.0931; 0.2613; 002960; 0.2552; 0.3165 | — |
| SECONDARY The Number of Subjects With Treatment-emergent Adverse Events |
15; 19; 18; 18; 17 | — |
| SECONDARY The Number of Subjects With Treatment-emergent Serious Adverse Events |
2; 2; 2; 1; 3 | — |
| SECONDARY The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation |
2; 3; 4; 3; 1 | — |
| SECONDARY The Percentage of Subjects With Treatment-emergent Adverse Events |
26.3; 34.5; 33.3; 31.6; 28.8 | — |
| SECONDARY The Percentage of Subjects With Treatment-emergent Serious Adverse Events |
3.5; 3.6; 3.7; 1.8; 5.1 | — |
| SECONDARY The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation |
3.5; 5.5; 7.4; 5.3; 1.7 | — |
Summary
This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects age 35 through 75 years, inclusive.
- A clinical diagnosis of moderate to severe COPD according to GOLD guidelines (2011).
- 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 MDI) FEV1 ≥ 30% and ≤ 70% of predicted normal value during the Screening Period.
- Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1/FVC ratio 10 hours per day.
- Use of systemic steroids within 3 months prior to the Screening Period.
- Respiratory tract infection within 6 weeks prior to or during the Screening Period.
- History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
- History of urinary retention or bladder neck obstruction type symptoms.
- History of narrow-angle glaucoma.
- Prolonged QTc interval (> 450msec for males and > 470msec for females) during the Screening Period, or history of long QT syndrome.
- Recent history (previous 12 months) of excessive use or abuse of narcotic/illegal drugs.
- History of hypersensitivity or intolerance to β2-agonists or anticholinergics.
- Participation in another investigational drug study where drug was received within 30 days prior to the Screening Period.
- Female subject who is pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT01706536). 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.