A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

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 (GOLD,
2011). The primary analysis will compare each of the EP-101 (SUN101) dose groups to placebo
with respect to the change from baseline in morning trough FEV1 on Day 29. Trough FEV1 is
defined as the mean of the two FEV1 values obtained at 23 hours 30 minutes and 24 hours after
Day 28 AM dose (ie, approximately 12 hours after the previous PM dose).

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 <
0.70 during the Screening Period.

- Post-bronchodilator (following inhalation of ipratropium bromide MDI) improvement in
FEV1 ≥ 12% and ≥ 100 mL during the Screening Period.

- Ability to perform reproducible spirometry according to the American Thoracic Society
(ATS) and European Respiratory Society (ERS) guidelines (2005).

- Subject, if female ≤ 65 years of age and of child bearing potential, must have a
negative serum pregnancy test at screening. Females of childbearing potential must be
instructed to and agree to avoid pregnancy during the study and must use an acceptable
method of birth control:

- a. An oral contraceptive, an intrauterine device (IUD), implantable
contraceptive, transdermal or injectable contraceptive for at least 1 month prior
to entering the study with continued use throughout the study and for thirty days
following study participation.

- b. Barrier method of contraception, eg, condom and/or diaphragm with spermicide
while participating in the study.

- c. Abstinence.

- Willing and able to provide written informed consent.

Exclusion Criteria:

- Current evidence or recent history of any clinically significant and unstable disease
(other than COPD) or abnormality in the opinion of the Investigator that would put the
subject at risk or which would compromise the quality of the study data; including but
not limited to cardiovascular disease, myocardial infarction, cardiac failure,
uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes,
neurologic or neuromuscular disease, liver disease, gastrointestinal disease or
electrolyte abnormalities.

- Current evidence or history of clinically significant abnormal cardiac rhythm and/or
conduction findings, including Holter monitoring results during the Screening Period.

- Concomitant pulmonary disease or primary diagnosis of asthma.

- 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

- Recent history of COPD exacerbation requiring hospitalization or need for increased
treatments for COPD within 6 weeks prior to the Screening Period.

- Use of daily oxygen therapy > 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