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Clinical Investigations: BRONCHITIS |

Efficacy and Safety of Azithromycin vs Levofloxacin in the Outpatient Treatment of Acute Bacterial Exacerbations of Chronic Bronchitis*

Guy W. Amsden, PharmD; Ian M. Baird, MD; Stuart Simon, MD, FCCP; Glenda Treadway, MD
Author and Funding Information

*From The Clinical Pharmacology Research Center and Department of Adult and Pediatric Medicine (Dr. Amsden), Bassett Healthcare, Cooperstown, NY; Riverside Methodist Hospital (Dr. Baird), Columbus, OH; Southeast Research Associates (Dr. Simon), Austell, GA; and Pfizer (Dr. Treadway), New York, NY.

Correspondence to: Guy W. Amsden, PharmD, Clinical Pharmacology Research Center, Bassett Healthcare, One Atwell Rd, Cooperstown, NY 13326; e-mail: guy.amsden@bassett.org



Chest. 2003;123(3):772-777. doi:10.1378/chest.123.3.772
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Study objectives: To compare the safety and efficacy of oral azithromycin and levofloxacin in the treatment of outpatients with acute bacterial exacerbations of chronic bronchitis (ABECB).

Design: Randomized, double-blinded, double-dummy, multicenter trial with 1:1 treatment allocation.

Setting: Outpatient treatment setting.

Patients: Two hundred thirty-five male or female outpatients between the ages of 35 and 75 years who had received a clinical diagnosis of ABECB.

Interventions: Blinded treatment with either oral azithromycin, 500 mg on day 1 and 250 mg per day for days 2 to 5, or, oral levofloxacin, 500 mg q24h for 7 days.

Results: Both treatments were well-tolerated, with the majority of adverse events being GI in nature. Favorable clinical outcomes in clinically evaluable patients were demonstrated in 89% of patients receiving azithromycin and in 92% of patients receiving levofloxacin by day 4 of therapy. At day 24, the posttherapy visit, favorable responses were approximately 82% and 86%, respectively, for patients in the two treatment groups. The bacterial eradication rates of respiratory pathogens were 96% for azithromycin and 85% for levofloxacin.

Conclusions: Despite increasing concerns over macrolide resistance and a higher incidence of Gram-negative pathogens, a standard 5-day course of oral azithromycin was clinically and bacteriologically equivalent to a 7-day course of oral levofloxacin in the treatment of patients with ABECB.


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