title: Prulifloxacin versus levofloxacin in the treatment of severe COPD patients with acute exacerbations of chronic bronchitis.
abstract: BACKGROUND
  Antimicrobial therapy of chronic bronchitis exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) is based on empiric antibiotic treatment.
  
  
  OBJECTIVE
  To evaluate the efficacy of prulifloxacin versus levofloxacin therapy in severe COPD patients with exacerbations of chronic bronchitis.
  
  
  METHODS
  This study involved a multicenter, parallel, double-blind, randomized clinical trial. Patients aged 40 years or older, smokers, or ex-smokers (>10 pack-years) with spirometrically confirmed severe COPD (FEV1 ≤ 50% predicted and FEV1/FVC ratio < 0.7) and diagnosed with an acute exacerbation of chronic bronchitis were enrolled in the study. Patients were randomized to receive prulifloxacin 600 mg once a day or levofloxacin 500 mg once a day for 7 days.
  
  
  RESULTS
  The primary outcome measure was clinical assessment at the TOC visit (7-10 days after the end of treatment) of signs and symptoms of exacerbation, namely sputum purulence, sputum volume, dyspnoea, cough and body temperature assessed through semi-quantitative scales. The ITT population included 346 (174 prulifloxacin, 172 levofloxacin) out of 351 treated subjects. A total of 161 patients with prulifloxacin (92.5%) and 166 with levofloxacin (96.5%) were considered cured at TOC (the difference in the percentage of cured patients was -3.98 with 95%CI of -8.76; 0.79). At the 6-month follow-up, the rates of patients with no relapse of AECB were higher than 95% in both the prulifloxacin and levofloxacin groups.
  
  
  CONCLUSIONS
  Both prulifloxacin and levofloxacin showed efficacy rates higher than 90% in the treatment of severe COPD patients with exacerbations of chronic bronchitis, with no statistically significant differences between the two antibiotics. The long-term follow-up confirmed a very low incidence of relapse, endorsing the appropriateness of this therapeutic approach. EUDRACT no. 2006-004167-56.
authors.affiliation: Dipartimento di Fisiopatologia e dei Trapianti, Università degli Studi di Milano, IRCCS Fondazione Ospedale Maggiore Policlinico Cà Granda Milano, Via Francesco Sforza 35, 20122 Milan, Italy. francesco.blasi@unimi.it
authors.forename: F
authors.initials: F
authors.lastname: Blasi
authors.forename: T
authors.initials: T
authors.lastname: Schaberg
authors.forename: S
authors.initials: S
authors.lastname: Centanni
authors.forename: A
authors.initials: A
authors.lastname: Del Vecchio
authors.forename: M T
authors.initials: MT
authors.lastname: Rosignoli
authors.forename: P
authors.initials: P
authors.lastname: Dionisio
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use; D029481:Bronchitis, Chronic / Q000188:drug therapy* / Q000503:physiopathology; D004148:Dioxolanes / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume; D006801:Humans; D064704:Levofloxacin / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D055502:Secondary Prevention; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D004148:Dioxolanes; D024841:Fluoroquinolones; D010879:Piperazines; D064704:Levofloxacin; C074191:prulifloxacin
keywords: Antibacterial agents; Chronic obstructive pulmonary disease; Exacerbation; Levofloxacin; Prulifloxacin; Randomized controlled clinical trial