title: Randomized, double-blind study comparing 5- and 7-day regimens of oral levofloxacin in patients with acute exacerbation of chronic bronchitis.
abstract: A randomized, double-blind, multicentre study was conducted in adult patients with acute exacerbation of chronic bronchitis (AECB), to compare the efficacy of a 5-day course of levofloxacin 500 mg once daily, with the standard 7-day regimen at the same dose. Five hundred and thirty-two patients from 48 centres in 10 countries were randomized to receive levofloxacin: 268 and 264 received the 5- and 7-day courses, respectively. The primary efficacy analysis was the clinical response at 7-10 days post-treatment in the per-protocol (PP) population. Clinical success rates in the primary PP analysis of 482 patients were 82.8% (197/238) for the 5-day group and 84.8% (207/244) for the 7-day group. The difference in success rates was -2.1% with a 95% CI of (-9.1 to 4.9%). The bacteriological response showed eradication rates of 82.1% (92/112) and 83.2% (84/101) in the 5- and 7-day groups, respectively. Both treatments were well tolerated. These results show that for patients with AECB levofloxacin 500 mg once daily for 5 days provides equivalent clinical and bacteriological success to the same dose given for 7 days irrespective of the patient's age, the frequency of exacerbations or the presence of co-existing cardiopulmonary or chronic obstructive airways disease.
authors.affiliation: The Royal Infirmary of Edinburgh, Lauriston Place, EH3 9YW, Edinburgh, UK. robert.masterton@luht.scot.nhs.uk
authors.forename: R G
authors.initials: RG
authors.lastname: Masterton
authors.forename: C J
authors.initials: CJ
authors.lastname: Burley
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D029481:Bronchitis, Chronic / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D064704:Levofloxacin; D015242:Ofloxacin