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Short Course of Moxifloxacin Effective for Bronchitis: Presented at ATS

By Charlene Laino

SEATTLE, WA -- May 22, 2003 -- A short course of moxifloxacin is superior to standard 7-day therapy for treatment of smokers with acute exacerbations of chronic bronchitis (AECB), according to results from the MOSAIC (Moxifloxacin compared to Standard therapy in Acute Infectious exacerbations of Chronic bronchitis) study.

Robert Wilson, MD, a consultant in respiratory medicine at Royal Brompton Hospital in London, United Kingdom, presented the findings here on May 21^st at the American Thoracic Society International Conference.

The postmarketing surveillance study was conducted to evaluate the efficacy and safety of 400mg/day of moxifloxacin in patients with AECB treated in the community-based setting.

The study evaluated 1,935 patients with chronic bronchitis and a history of smoking. During a 12-month monitoring period, 733 patients had an AECB episode and were randomized to receive 5 days of moxifloxacin or 7 days of either 500 mg of amoxicillin twice a day, 500 mg of clarithromycin twice a day, or 250 mg of cefuroxime-axetil twice a day.

After 7 to 10 days, symptoms of AECB, including cough, expectoration, dyspnea, chest pain and fever, resolved in 70.9% of patients in the moxifloxacin arm, compared with 62.8% in the comparator arm (P=0.05).

The bacteriological success rates were 92% in the moxifloxacin group, compared with 81% in the standard treatment arm (P=0.05). Also, the percentage of patients requiring additional antibiotics was significantly lower in the moxifloxacin arm than in the standard therapy arm: 31% vs. 40%, the study showed.

The average interval between AECB episodes for patients on moxifloxacin was about 2 weeks longer than for those on standard therapy.

Adverse events were usually mild to moderate in intensity and reported by comparable number of patients in both groups: 7.1% in the moxifloxacin arm vs. 4.8% in the comparator arm.

About 8.8 million Americans have chronic bronchitis, with smokers twice as likely to be affected as nonsmokers, Dr. Wilson said.

"The study shows that a short course of moxifloxacin provides higher bacterial eradication and clinical cure rates than the standard 7-day regimen," he said.

The study was funded by Bayer Pharmaceuticals, makers of moxifloxacin.


[Study title: A Clinical and Outcome Assessment of Moxifloxacin (MXF) vs. Standard Antibiotic Regimen (STD) for Acute Exacerbations of Chronic Bronchitis (AECB): The MOSAIC Study. Poster 214]

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