MULTICENTER COMPARISON OF AZITHROMYCIN AND AMOXICILLIN/CLAVULANATE IN THE TREATMENT OF PATIENTS WITH ACUTE EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY-DISEASE

This randomized, multicenter, investigator-blinded, parallel-group study compared a 5-day, once-daily course of azithromycin (two 250-mg capsules on day 1, followed by one 250-mg capsule on days 2 through 5) with a 10-day, three-times-daily course of amoxicillin/clavulanate (one 500-mg tablet) in 70 patients with acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD; chronic bronchitis). At the end of therapy, all 29 (100%) efficacy-assessable patients treated with azithromycin were cured or improved, compared with 25 (93%) of 27 assessable patients given amoxicillin/clavulanate (P = NS). Bacteriologic eradication rates were 86% (25/29 isolates) with azithromycin and 87% (20/23 isolates) with the comparative agent. Azithromycin was well tolerated; adverse events considered related or possibly related to treatment were reported in 28% of azithromycin recipients, compared with 39% of amoxicillin/clavulanate recipients (P = NS). The 5-day, once-daily regimen-of azithromycin is comparable to a standard agent in the treatment of patients with acute bacterial exacerbations of COPD.