A randomized, double-blind study comparing 5 days oral gemifloxacin with 7 days oral levofloxacin in patients with acute exacerbation of chronic bronchitis.
OBJECTIVE
To demonstrate that 5 days of treatment with a new fluoroquinolone, gemifloxacin, is at least as effective as 7 days of treatment with levofloxacin in adult patients with acute exacerbation of chronic bronchitis (AECB).


METHODS
Randomized, double-blind, double dummy, multicentre, parallel group study


METHODS
Sixty different medical centers in US, UK and Germany.


METHODS
A total of 360 adults (>40 years of age) with AECB were randomly assigned to receive gemifloxacin 320 mg once daily for 5 days or levofloxacin 500mg once daily for 7 days. The primary efficacy parameter was a clinical response at follow-up (Days 14-21).


RESULTS
In total, 335/360 patients completed the study (93.1%). Seven patients receiving gemifloxacin withdrew from the study compared to 18 patients receiving levofloxacin; this difference was statistically significant (Fisher's exact test: p=0.02). In the intent-to-treat (ITT) population, the clinical success rate at follow-up (Days 14-21) was 85.2% (155/182) with gemifloxacin and 78.1% (139/178) with levofloxacin. Clinical success rate in the per-protocol (PP) population was 88.2% (134/152) with gemifloxacin and 85.1% (126/148) with levofloxacin. At long-term follow-up (Days 28-35), the clinical success rates in the PP population were 83.7% (123/147) with gemifloxacin and 78.4% (109/139) with levofloxacin. The difference in success rates was 5.26% (95% CI: -3.83, 14.34).


CONCLUSIONS
The clinical efficacy of gemifloxacin 320 mg once daily for 5 days in AECB was at least as good as levofloxacin 500 mg once daily for 7 days. Fewer withdrawals and superior clinical efficacy at long-term follow-up were also seen with gemifloxacin.
Sethi
S
S
Pulmonary and Critical Care Medicine, University at Buffalo, State University of New York, Buffalo, NY, USA. ssethi@buffalo.edu
Fogarty
C
C
Fulambarker
A
A
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001991:Bronchitis / Q000188:drug therapy*; D002908:Chronic Disease; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000009:adverse effects; D000077735:Gemifloxacin; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D009287:Naphthyridines / Q000008:administration & dosage* / Q000009:adverse effects; D015242:Ofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D009287:Naphthyridines; D064704:Levofloxacin; D015242:Ofloxacin; D000077735:Gemifloxacin