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Moxifloxacin Betters Standard Regimen for Treating Chronic Bronchitis Exacerbations: Presented at CHEST

By Mike Fillon

ORLANDO, FL -- November 4, 2003 -- A new study shows patients with acute exacerbations of chronic bronchitis (AECB) who took a five-day course of the antibiotic moxifloxacin HCL, required fewer follow-up antibiotics to achieve clinical success and experienced significantly more time to next AECB reoccurrences than patients who took a seven-day course of standard antibiotics.

The findings were part of the MOSAIC study, a multi-centre, multi-national randomized, double-blind study of two parallel arms designed to reproduce the real-world conditions in a physician's office. Results of the study were presented here at CHEST 2003, the 69^th Annual International Scientific Assembly of the American College of Chest Physicians (ACCP).

Enrolled patients in the MOSAIC study were 45 years of age or older who had stable chronic bronchitis and severe AECB within 12 months of enrollment. During a 12-month monitoring period, 730 patients had an AECB episode and were randomized to receive moxifloxacin (400 mg, once daily for five days), or a standard treatment regimen consisting of amoxicillin (500 mg, three times daily for seven days), clarithromycin (500 mg, twice daily for seven days) or cefuroxime-axetil (CMP) (250 mg, twice daily for seven days).

Study results showed that moxifloxacin had a significantly greater clinical cure rate compared to the standard treatments with amoxicillin, clarithromycin or CMP. The study also showed a five-day course of once-daily moxifloxacin was equivalent to the others taken for seven days either two or three times a day.

According to the researchers, moxifloxacin demonstrated significantly higher bacteriologic eradication rates in all subgroups analyzed, as compared to patients who received amoxicillin, clarithromycin or CMP. These results were consistent among all prognostic subgroups, including the most severely ill patients, who were identified by factors such as co-existing cardiopulmonary disease and a period of less than six months between AECB.

Specifically, moxifloxacin demonstrated a higher patient cure rate across all factors, which included:
· More than four AECB episodes per year (59% of moxifloxacin patients vs. 55% of standard therapy patients)
· Cardiopulmonary disease (56% of moxifloxacin vs. 38% for the others)
· A FEV₁ of >/=70% (80% of moxifloxacin vs. 68% of standard therapy patients)
· Concomitant steroid use (67% of moxifloxacin vs. 59% of the others)
· Experienced symptoms of chronic bronchitis for >/=15 years (67% for moxifloxacin vs. 58% for the others).


[Study title: The Mosaic Study: A New Landmark in the Therapy of Acute Exacerbations of Chronic Bronchitis.]

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