Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4)
Condition: COPD; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: SUN-101 50 mcg BID eFlow (CS) nebulizer; SUN-101 25 mcg BID eFlow (CS) nebulizer; Placebo eFlow (CS) nebulizer
Intervention description: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer; SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer; Placebo BID eFlow (R) Closed System (CS) nebulizer
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 641.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; COPD

Summary:

      This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational
      eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease
      (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014)
      guidelines.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients age ≥ 40 years, inclusive

          2. A clinical diagnosis of COPD according to the GOLD 2014 guidelines

          3. Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least
             1 pack/day for 10 years, or equivalent)

          4. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 < 80% of
             predicted normal and > 0.7 L during Screening (Visit 1)

          5. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio <
             0.70 during Screening (Visit 1)

          6. Ability to perform reproducible spirometry according to the American Thoracic Society
             (ATS) and European Respiratory Society (ERS) guidelines (2005)

          7. Subject, if female ≤ 65 years of age and of child bearing potential, must have a
             negative serum pregnancy test at Visit 1. 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 participation; b) barrier method of contraception, eg, condom
             and /or diaphragm with spermicide while participating in the study; and/or c)
             abstinence

          8. Willing and able to provide written informed consent

          9. Willing and able to attend all study visits and adhere to all study assessments and
             procedures

        Exclusion Criteria:

          1. Severe comorbidities including unstable cardiac or pulmonary disease or any other
             medical conditions that would, in the opinion of the Investigator, preclude the
             subject from safely completing the required tests or the study, or is likely to result
             in disease progression that would require withdrawal of the subject

          2. Concomitant clinically significant respiratory disease other than COPD (eg, asthma,
             tuberculosis, bronchiectasis or other non-specific pulmonary disease).

          3. Recent history of COPD exacerbation requiring hospitalization or need for increased
             treatments for COPD within 6 weeks prior to Screening (Visit 1).

          4. Use of daily oxygen therapy > 12 hours per day

          5. Respiratory tract infection within 6 weeks prior to Screening (Visit 1)

          6. Use of oral, intravenous, or intramuscular steroids within 3 months prior to Screening
             (Visit 1)

          7. 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

          8. Prolonged QTcF (> 450 msec for males and > 470 msec for females) during Screening
             (Visit 1) as determined from the report provided by the central laboratory, or history
             of long QT syndrome

          9. History of or clinically significant on-going bladder outflow obstruction or history
             of catheterization for relief of bladder outflow obstruction within the previous 6
             months

         10. History of narrow angle glaucoma

         11. History of hypersensitivity or intolerance to aerosol medications

         12. Recent documented history (within the previous 3 months) of substance abuse

         13. Significant psychiatric disease that would likely result in the subject not being able
             to complete the study, in the opinion of the Investigator

         14. Participation in another investigational drug study where drug was received within 30
             days prior to Screening (Visit 1) or current participation in another investigational
             drug trial, including a SUN-101 study

         15. Previously received SUN-101 (active treatment; formerly known as EP-101)

         16. Contraindicated for treatment with, or having a history of reactions/hypersensitivity
             to anticholinergic agents, beta2 agonists, or sympathomimetic amines