EFFECT OF CHRON MACROLIDE ADMIN ON FREQUENCY & SEVERITY OF COPD EXACERBATIONS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Chronic obstructive pulmonary disease (COPD in short) is a disease of the lungs that affects many smokers. During the course of this chronic condition, some patients develop one or more COPD "exacerbations" (that is, a temporary worsening of lung symptoms that may require hospitalization and could be life-threatening). Currently, COPD affects from 12.4 to 24 million people in the United States and is the fourth leading cause of death. Worldwide, COPD is the sixth leading cause of death and is the only condition in the top 10 causes of death that has an increasing of new diagnosis and death rates. It is therefore important to find a treatment that could prevent COPD exacerbations,reduce the severity of the episodes, and the mortality of the patients this disease affects. This project addresses an objective stated in the U.S. Public Health Service report "Healthy People 2010: Reduce deaths from COPD from 119 per 1000 people to 60 per 1000 people by 2010" (Objective 24-10). If the intervention that we propose reduces the rate or severity of COPD exacerbations it would be expected to reduce the rate of deaths of these patients. The study is broken down into three separate protocols, the Macrolide (parent) Protocol, the Biomarker and Genetic substudies. All study protocols have been incorporated into one consent document. Subjects will be given the opportunity to continue to participate in the Macrolide and Biomarker study, should they decide not to participate in the Genetic substudy. The Macrolide (parent) Protocol specific aim is to determine if the administration of a macrolide antibiotic (specifically Azithromycin) for one year will decrease the rate and the severity of COPD exacerbations when added to the usual care of these patients. The Biomarker Substudy: specific aims are to determine how certain biomarkers (chemicals) in the blood are related to respiratory conditions. The Genetic Substudy: specific aims of the genetic substudy are to collect blood from this patient population for future studies of smoking related diseases, including chronic obstructive pulmonary disease. The study is funded by the National Institutes of Health and is conducted by Dr. Martinez at the University of Michigan and researchers from nine other research institutions in the United States. We plan to enroll about 110 patients at the University of Michigan and over 1,100 patients nationally over a three year period of time.'