SPARFLOXACIN VS OFLOXACIN IN THE TREATMENT OF ACUTE BACTERIAL EXACERBATIONS OF CHRONIC-BRONCHITIS - A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, COMPARATIVE-STUDY

Study objective: Comparison of efficacy and safety of sparfloxacin vs ofloxacin for treatment of acute bacterial exacerbations of chronic br onchitis (ABECB), Design: Multicenter, double-blind, randomized study. Setting: Sir;ty-eight private offices and outpatient clinics in the U nited States and Canada. Patients: Seven hundred ninety-eight adults w ith ABECB, as confirmed by the acute onset of new (or worsened from th e immediate premorbid state) cough and sputum production, Intervention s: Randomization 1:1 to sparfloxacin, 400 mg on day 1, then 200 mg onc e daily, or ofloxacin, 400 mg twice daily, with matching comparator pl acebos, given concurrently for 10 consecutive days. Results: The prima ry efficacy parameter was overall response ire the bacteriologically e valuable population, Overall success rates in this population were 85. 3% and 89.3% for sparfloxacin and ofloxacin, respectively. The two-sid ed 95% confidence interval was -9.9, 1.9, indicating that sparfloxacin was statistically equivalent to ofloxacin. The all-treated population analysis was similar to that in the evaluable population. Bacterial e radication rates were similar in both treatment groups for Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis, Chlamydi a pneumoniae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Enter obacter cloacae, and Staphylococcus aureus, The frequency of adverse e vents overall was comparable in the two treatment groups. The sparflox acin group had a lower frequency of digestive and nervous system adver se events, but a higher frequency of photosensitivity reactions than t he ofloxacin group. Conclusions: Once-daily oral treatment with 200 mg sparfloxacin (after initial 400 mg dose) is as effective as twice-dai ly treatment with 400 mg ofloxacin in patients with ABECB.