Chronic obstructive pulmonary disease (COPD) is a deadly and morbid disorder that accounts annually for more than 600,000 hospitalizations and 13.4 million physician office visits. More than $15 billion are expended per year in direct medical costs for COPD, and approximately $9.9 billion are lost in reduced work productivity. The prevalence, morbidity, and mortality associated with COPD is increasing at an alarming rate, both in the United States and worldwide. There is a growing awareness that exacerbations of COPD are not only associated with a worsening of the patient's quality of life, but are directly responsible for patient hospitalization, increasing mortality, and increasing costs of care. The purpose of this project is to participate in the National, Heart, Lung, and Blood Institute (NHLBI) COPD Clinical Research Network (CRN) to investigate in a multidisciplinary fashion, disease management approaches in patients with moderate to severe COPD. We also propose to develop a Clinical Research Skills Development Core to assist new clinical investigators at Temple in developing clinical skills needed to develop clinical investigative programs. This program will also be used to further hone the skills of current investigators to progress to a more senior investigative status. Specific objectives of the COPD Clinical Research Network will be to: 1) strengthen the knowledge base for therapeutic decision-making by testing particular approaches in the management of moderate to severe COPD; 2) improve the management of co-morbid conditions associated with COPD; 3) develop methods for predicting individual patient responsiveness to treatments, and; 4) evaluate and correlate various outcome measures. The specific objectives of our 2 technical proposals are to address two important issues in COPD in a manner that satisfies the overall objectives of the COPD Clinical Research Network. We intend to: 1) determine the effect of chronic, nocturnal oxygen administration vs placebo in moderate to severe COPD patients whom exhibit nocturnal oxygen desaturation on sleep quality, functional performance, right heart function, quality of life, and COPD exacerbation frequency, and: 2) to determine the inciting factors, pattern of resolution, management of disease, and the genomics of COPD exacerbations requiring hospitalization in minority patients (African American) compared to Caucasians.
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