CLINICAL TRIAL: EFFECT OF CHRONIC MACROLIDE ADMINISTRATION ON 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. The objective of this study is to determine if chronic administration of a macrolide antibiotic will reduce the morbidity of COPD. This will be a prospective, randomized, double-blind, placebo-controlled clinical trial. A total of 1130 subjects at 7 clinical sites with at least moderately severe COPD will be randomized to either azitrhromycin 250mg every day or matching placebo. The rationale for this study is that the prevalence, morbidity, mortality, and treatment costs of COPD are high and increasing. A large portion of the morbidity and costs are related to acute exacerbations. Macrolide antibiotics have a variety of antibacterial and anti-inflammatory properties that in theory could reduce acute exacerbations.