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
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: EP-101 via nebulizer (eFlow®) 25 ug; EP-101 via nebulizer (eFlow®) 50 ug; EP-101 via nebulizer (eFlow®) 100 ug; Placebo EP-101; Tiotropium bromide via (Spiriva® Handihaler®); Ipratropium bromide Inhalation Solution via Handihaler® DPI; EP-101 via nebulizer (eFlow®) 200 ug
Intervention description: EP-101 (25 ug ) Dose 1 administered once daily for 7 days; EP-101 (50 ug ) administered once daily for 7 days; EP-101 (100ug) administered once daily for 7 days; Placebo EP-101 administered once daily for 7 days; Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI; Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer; EP-101 (200) ug administered once daily for 7 days
Intervention MeSH terms: Bromides; Tiotropium Bromide; Ipratropium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: COPD

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).
    

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