A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Placebo; EP-101 12.5 mcg; EP-101 25 mcg; EP-101 50 mcg; EP-101 100 mcg
Intervention description: EP-101 Placebo AM + EP-101 Placebo PM; EP-101 12.5 mcg AM + EP-101 12.5 mcg PM; EP-101 25 mcg AM + EP-101 25 mcg PM; EP-101 50 mcg AM + EP-101 50 mcg PM; EP-101 100 mcg AM + EP-101 100 mcg PM
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 275.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No

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 <
             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