A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD

Exclusion Criteria

• •1. 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.
• •2. Current evidence or history of a clinically significant abnormality of cardiac rhythm and/or conduction including Holter monitoring prior to randomization.
• •3. Primary diagnosis of asthma.
• •4. 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.
• •5. Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening.
• •6. Use of daily oxygen therapy \> 10 hours per day.
• •7. Use of systemic steroids within 3 months prior to Screening.
• •8. Respiratory tract infection within 6 weeks prior to or during Screening.
• •9. History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
• •10. History of urinary retention or bladder neck obstruction type symptoms.
• •11. History of narrow angle glaucoma.
• •12. Prolonged QTcF interval (males \> 450 msec and females \>470 msec) during Screening, or history of long QT syndrome.
• •13. Recent history (previous 12 months) of excessive use or abuse of alcohol or narcotic/illegal drugs.
• •14. History of hypersensitivity or intolerance to aerosol medications, beta-2 agonists, or anticholinergics.
• •15. Participation in another investigational drug study where drug was received within 30 days prior to Screening, or current participation in another investigational drug trial.
• •16. Subject is a staff member of the clinical site or a relative of a clinical site staff member.