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 1993, the estimated direct medical costs of COPD were $14.7 Billion. Also during 1993, 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 $23.9 Billion. Healthy People 2010 includes two objectives related to COPD: to reduce the proportion of adults whose activity is limited because of chronic lung and breathing problems to 1.5% (Objective 24-9) and to reduce deaths from COPD among adults aged >45 years to 60 deaths/100,000.

During 2000, an estimated 10 million U.S. adults reported physician-diagnosed COPD. However, data from NHANES III estimate that approximately 24 million U.S. adults have evidence of impaired lung function, indicating that COPD is under diagnosed.

During 2000, COPD was responsible for 8 million physician office and hospital outpatient visits, 1.5 million emergency department visits, 726,000 hospitalizations, and 119,000 deaths. During the period analyzed, the most substantial change was the increase in the COPD death rate for women, from 20.1/100,000 in 1980 to 56.7/100,000 in 2000, compared with the more modest increase in the death rate for men, from 73.0/100,000 in 1980 to 82.6/100,000 in 2000. In 2000, for the first time, the number of women dying from COPD surpassed the number of men dying from COPD (59,936 versus 59,118). Chronic Obstructive Pulmonary Disease Surveillance United States, 1971-2000 David M. Mannino, M.D.1; David M. Homa, Ph.D.1. Lara J. Akinbami, A1.D.2. Earl S. Ford, M.D. Stephen C. Redd, M.D.

History of COPD

A recent American Lung Association survey revealed that half of all COPD patients (51%) say their condition limits their ability to work. It also limits them in normal physical exertion (70%), household chores (56%), social activities (53%), sleeping (50%), and family activities (46%). None of the existing medications for COPD has been shown to modify the long-term decline in lung function that is the hallmark of this disease. Therefore, pharmacotherapy for COPD is used to decrease symptoms and/or complications.

Bronchodilator medications are central to the symptomatic management of COPD. Additional treatment includes antibodies, oxygen therapy, and systemic glucocorticosteroids. The efficacy of inhaled glucocorticosteroids is under study. Chronic treatment with steroids should be avoided because of unfavorable benefit-to-risk ratio. Pneumonia and Influenza vaccines should be given to COPD patients. To reduce and control symptoms of chronic bronchitis, sufferers should live a healthy lifestyle by exercising, avoiding cigarette smoke and other air pollutants, and eating well. Lung transplantation is being performed in increasing numbers and may be an option for people who suffer from severe emphysema.

COPD is a major cause of morbidity, mortality, and disability in the United States. Despite its ease of diagnosis, COPD remains an under diagnosed disease, chiefly in its milder and more treatable form.

The FDA has determined that N115 has sufficient safety toxicology and clinical data to proceed with the multi-dose, extended use, clinical trials. Phase III/Phase IV studies will focus on asthmatics and COPD patients. On the basis of existing clinical data, EmphyCorp is confident that its Investigative New Drug, N115, can and will be used for maintenance or continuous treatment of patients over extended periods of time. The Company believes that N115 will set the standard in the pharmaceutical industry for the treatment of major pulmonary diseases.

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