CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Chronic obstructive pulmonary disease (COPD) is a group of diseases characterized by airflow obstruction that includes emphysema, chronic bronchitis, asthma and diseases that are characterized by obstruction to air flow and are associated with breathing-related symptoms (e.g., chronic cough, exertional dyspnea, expectoration, and wheeze).

COPD can be present with or without substantial physical impairment or symptoms, and it is the fourth leading cause of death in the United States. However, COPD is often a silent and unrecognized disease, chiefly in its early phases. During 2020, the estimated direct medical costs of COPD were $24.7 Billion. Also, the estimated indirect cost related to morbidity (e.g., loss of work time and productivity) and premature mortality was an additional $9.2 Billion, for a total of $33.9 Billion.

The FDA has determined that N115 has sufficient safety toxicology and clinical data to proceed with the multi-dose, extended use, clinical trials.