EVALUATE THE EFFICACY AND SAFETY OF ENSIFENTRINE OVER 24 WEEKS IN PATIENTS WITH MODERATE TO SEVERE COPD.
Age: Patient must be 40-80 years of age inclusive.
Inclusions:
Smoking ≥10 pack years
Exclusions:
24/7 oxygen therapy
Psychiatric medication
History of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation
Hospitilizations for COPD, pneumonia, or Corona Virus Disease 2019 (COVID-19) in the 12 weeks prior to Screening and/or a positive COVID-19 test result indicating an active yeast infection at Screening.
COPD exacerbation requiring oral or parenteral steroids within 3 months of Screening.
Previous lung resection or lung reduction surgery within 1-year of Screening.
Long term oxygen use defined as oxygen therapy prescribed for greater than 12 hours per day.
Pulmonary rehabilitation, unless such treatment has been in a stable maintenence phase for 4 weeks prior to Visit 1.