A new study shows patients with acute exacerbations of chronic bronchitis (AECB) who took a five-day course of the antibiotic Avelox (moxifloxacin HCl) achieved a greater clinical cure rate than patients who took a seven-day course of the antibiotics most commonly prescribed to treat AECB, such as clarithromycin, amoxicillin and cefuroxime-axetil.

The results of the MOSAIC study, a major clinical trial, were published in the March issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.

In the MOSAIC study, clinical success was defined as the resolution or improvement of all AECB signs and symptoms, which include the sudden onset of increased coughing and sputum production and shortness of breath. The study demonstrated excellent clinical success for a five day course of Avelox taken once daily, which was equivalent to comparators taken for seven days either two or three times a day.

"In people with chronic bronchitis, AECB leads to lost productivity and diminished quality of life," said Dr. Antonio Anzueto, Associate Professor of Medicine, University of Texas Health Science Center, San Antonio. "This study shows that Avelox may provide improved patient outcomes for a condition that is more painful and debilitating than it is generally perceived to be, and that is good news for millions of people worldwide."

More than 14 million Americans suffer from chronic bronchitis, and according to data collected in the mid-1990s, AECB represents a burden of more than $2.4 billion to the US healthcare system. AECB is often caused by bacterial infections. Over time, repeated AECB episodes can lead to deteriorating lung function. More than 1,100 Americans died as a result of chronic bronchitis in the year 2000.

Previous antibiotic trials in AECB have been limited by inadequate information on patient condition prior to AECB and lack of long-term follow-up. In MOSAIC, chronic bronchitis patients were enrolled during their "healthy state" (between their exacerbations) and not randomized until signs of an exacerbation occurred. This provided a highly accurate "real world" measurement of symptom relief as patients cleared their infection and returned to baseline health status. The study design also included a follow-up visit after nine months to assess long-term outcomes, including time until their next exacerbation.

In addition to significantly greater clinical cure, treatment with Avelox was also associated with significantly higher rates of bacterial eradication, a reduced need for additional antibiotics, and an average of two additional AECB-free weeks compared to patients who took standard therapy. These results were consistent among all patient subgroups, including the moderately ill up to the most severely ill, who were identified by factors such as co-existing cardiopulmonary disease and a period of less than six months between AECB.

"MOSAIC is a unique design because it is the first antibiotic trial in AECB to examine these endpoints together in one study," said Anzueto. "And the resulting picture of outcomes in the AECB patient is one of the most complete and informative we have ever seen."

Avelox demonstrated a significantly greater clinical cure rate (70.9 per cent vs. 62.8 per cent in the comparator arm) and a significantly higher bacteriological response rate (92 per cent vs. 81 per cent in the comparator arm). Significantly fewer patients who took Avelox required additional post-therapy antibiotics (7.6 per cent of Avelox patients vs. 14.1 per cent of patients taking standard therapy in the "intent-to-treat" population and 8.8 per cent Avelox vs. 14.8 per cent standard therapy in the per-protocol population). Time to next exacerbation measured at nine-month follow-up showed that for patients who took Avelox, the average interval between episodes of AECB was approximately two weeks longer than for those who took standard therapy.

MOSAIC was a multi-center, multi-national, randomized, double-blind study of two parallel treatment arms designed to reproduce the real-world conditions of the physician's office. Enrolled patients were 45 years of age or older who had stable chronic bronchitis, a history of cigarette smoking and severe AECB within 12 months of enrollment. During a 12-month monitoring period, 730 patients had an AECB episode and were randomized 1:1 to receive Avelox (400mg, once daily, for five days) or a standard treatment regimen consisting of amoxicillin (500mg, three times daily, for seven days) or clarithromycin (500mg, twice daily, for seven days) or cefuroxime-axetil (250mg, twice daily, for seven days). The primary endpoint was clinical success (resolution or improvement) at seven-to-ten days following treatment.

Chronic obstructive pulmonary disease (COPD), an underlying cause of chronic bronchitis and AECB, is a massive burden on international healthcare systems and the fourth leading cause of death globally. In spite of several high profile efforts to curb the spread of COPD - largely by encouraging people not to smoke - recent data suggest that COPD is growing at an alarming rate among several populations, most significantly in women. Overall, women have higher rates of chronic bronchitis than men. In 2001, 7.5 million women were diagnosed with chronic bronchitis compared to 3.7 million men, while the year 2000 marked the first time that more women than men died from COPD.6

Avelox is approved to treat: Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, or Moraxella catarrhalis; Community Acquired Pneumonia (CAP) caused by Streptococcus pneumoniae (including penicillin-resistant strains, MIC value for penicillin ≥ 2 µg/mL), Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae; Acute Bacterial Sinusitis (ABS) caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis; and uncomplicated Skin and Skin Structure Infections (uSSSI) caused by Staphylococcus aureus or Streptococcus pyogenes.

Avelox is a prescription medication that is generally well tolerated. The most common side effects, which are usually mild, include nausea, diarrhea, and dizziness. You should be careful about driving or operating machinery until you are sure Avelox is not causing dizziness.

You should not take Avelox if you have ever had an allergic reaction to Avelox or any of the other group of antibiotics known as "quinolones," such as ciprofloxacin or levofloxacin. You should avoid taking Avelox if you have been diagnosed with an abnormal heartbeat such as an arrhythmia or are using certain medications used to treat an abnormal heartbeat. These include quinidine, procainamide, amiodarone, and sotalol.

If you are pregnant or planning to become pregnant while taking Avelox, talk to your healthcare provider before taking this medication. Avelox is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Avelox is not recommended for children under the age of 18 years.