Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD

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 ongoing 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