A randomized, double-blind, double-dummy trial was performed comparing 200 mg of cefditoren-pivoxil twice daily for 5 days versus standard cefuroxime-axetil treatment (250 mg twice daily for 10 days) of Anthonisen type I or II acute exacerbations of chronic bronchitis. The modified intention-to-treat population included 541 patients. Patients were assessed during therapy, at the end of therapy (visit 3; primary evaluation time point), and at follow-up. Clinical success was obtained in 79.9% of the 264 patients included in the cefditoren-pivoxil group and in 82.7% of the 277 patients in the cefuroxime-axetil group (treatment difference, 95% confidence interval [CI]: ؊2.8, ؊9.7 to 3.6%). Treatment clinical effects were more clearly seen in sputum signs (decreasing volume and purulence from approximately 80% to approximately 10% of the patients). At the end of treatment, exploratory analysis of the per-pathogen bacteriological response showed 72.8% (of 103 isolates) in the cefditoren-pivoxil arm versus 67.0% (of 94 isolates) in the cefuroxime-axetil group (treatment difference; 95% CI: 5.8, ؊7.0 to 18.6%). Globally, the per-pathogen bacteriological response correlated well with clinical success: 83.5% of 164 baseline isolates from patients with a clinical success were eradicated or presumably eradicated, in contrast to only 3% of 33 isolates from patients with a clinical failure. Clinical success in patients infected with Haemophilus influenzae, the most frequent isolate, was 84% (of 50) and 82.5% (of 40) (treatment difference; 95% CI: 1.5, ؊14 to 17%) in the cefditoren-pivoxil versus the cefuroxime-axetil group. Although this study does not prove that either drug is better than a placebo, cefditoren-pivoxil and the standard 10-day cefuroxime-axetil course had similar point estimates of success in acute exacerbations of chronic bronchitis.Feelings related to acute exacerbations of chronic bronchitis (AECB), such as embarrassment about symptoms, are identified factors reducing patients' perceived quality of life (17). Although there is not a uniform definition of AECB episodes (15), they are characterized by the following main symptoms: increase in baseline dyspnea, increase in sputum volume, and/or appearance of purulent expectoration (28). According to the presence of these symptoms, exacerbations are classified by Anthonisen as types I (three symptoms), II (two symptoms), and III (one symptom) (1). At least half of AECB cases are presumably caused by bacterial infection (4, 13), which may respond primarily to antibiotics. Despite the fact that many of these patients are treated with antibiotics, the efficacy of this approach has been questioned (11) because previous trials have not shown a benefit over placebo administration (14). Nevertheless, other studies (1, 22) have described small but statistically significant improvements of clinical outcomes in ambulatory patients with type I and type II exacerbations treated with broad-spectrum antibiotics.Sputum purulence is strongly associated with the presence of bact...