Emphysema
EMPHYSEMA
Emphysema is a condition in which there is over-inflation of alveoli or air sacs. This over-inflation results from a breakdown of the walls of the alveoli, which causes a decrease in respiratory function and often, breathlessness.
Early symptoms of emphysema include inflammation, shortness of breath (dyspnea), Hypoxemia, fatigue, low SaO2, and coughing.
Emphysema ranks ninth among chronic conditions that contribute to lack of activity: over 42% of individuals with emphysema report that their daily activities have been limited by the disease.
Asthma
ASTHMA
According to the most recent study of asthma prevalence conducted by the Centers for Disease Control and Prevention, 31.3 million people (114 people per 1,000 – U.S.) had ever been diagnosed with asthma during their lifetime.
When race/ethnicity is considered, current asthma prevalence was about 10% higher among non-Hispanic blacks compared to non-Hispanic whites and about 40% higher compared to Hispanics. Females had a 30% higher prevalence compared to males. However, this pattern was reversed among children. The current asthma prevalence rate for boys aged 0-17 years (99 per 1,000) was over 30% higher than the rate among girls (74 per 1,000).
One of the defining characteristics of asthma is that the airway obstruction is reversible (though not always completely reversible) and may resolve on its own or with treatment.
Since the airway obstruction is variable, asthma may be described as “episodic” in that most people who have it breathe normally or near normally between episodes or acute attacks. In addition to being episodic, asthma is also considered to be chronic (an ongoing problem) and people with asthma have airways that remain inflamed and may get constricted after exposure to an asthma trigger.
Chronic Obstructive Pulmonary Disease
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.