Macrolide Azithromycin to Prevent Rapid Worsening of Symptoms Associated With Chronic Obstructive Pulmonary Disease

Exclusion Criteria

• •Diagnosis of asthma
• •Diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy less than 3 years
• •Special patient groups (i.e., prisoners, pregnant women, or institutionalized patients)
• •Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (i.e., hormone-based oral or barrier contraceptive) for the duration of the study
• •History of hypersensitivity to any macrolide antibiotic
• •Taking any of the following medications:
• •1. Cisapride
• •2. Ergot derivatives
• •3. Pimozide
• •4. Disopyramide
• •5. Cyclosporin
• •6. Tacrolimus
• •7. Nelfinavir
• •8. Bromocriptine
• •9. Hexobarbital
• •Corrected QT interval (QTc) on electrocardiogram exceeding 440 ms
• •Taking rifabutin or rifampin
• •Chronic hepatic insufficiency
• •Chronic renal insufficiency
• •Diagnosis of bronchiectasis (defined as production of greater than one-half cup of purulent sputum/day)
• •If, for either ear, formal audiometric testing in a sound booth results in a pure tone average (i.e., the average of the thresholds for the 4 frequencies 1000, 2000, 3000, or 4000) exceeding 50 decibel (dB), or if the threshold at any one frequency exceeds 60 dB, then the participant will be counseled by the audiologist concerning hearing aids and/or referral to an otolaryngologist. In addition, the audiologist may discuss with the participant whether or not to continue in the study. Following the examination and counseling, the participant will also discuss whether or not to continue in the study with one of the study investigators. If it is found that a participant's pure tone average in the two ears differs by more than 15 dB, or if the difference in the two ears for any one frequency exceeds 20 dB, then the participant will not be eligible for randomization into the study unless cleared by an otolaryngologist