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The MOSAIC Study Shows that Treatment with Avelox Provides Superior Clinical and Bacteriological Success, More Time Between Bronchitis Flare-Ups and Requires Significantly Fewer Follow-Up Antibiotics Compared to Some Standard Treatments
LEVERKUSEN, GERMANY, March 8, 2004 – A new study shows patients with acute exacerbations of chronic bronchitis (AECB) who took a five-day course of the antibiotic Aveloxâ (moxifloxacin HCl) achieved superior clinical cure compared to 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 today in the March issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.
In the MOSAIC study, clinical cure was defined as the resolution of all AECB signs and symptoms, which include the sudden onset of increased coughing and sputum production and shortness of breath.
"In people with chronic bronchitis, AECB leads to lost productivity and diminished quality of life," said Dr. Robert Wilson, Royal Brompton and Harefield Hospital, London, UK, and principal MOSAIC investigator. "This study shows that Avelox can provide improved patient outcomes for a condition that is more painful and debilitating than it is generally perceived, which is good news for millions of people worldwide."
AECB are often caused by bacterial infections. Over time, repeated AECB episodes can lead to deteriorating lung function.
MOSAIC: A Real-World Study
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 stable phase (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 infections 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 superior clinical success, treatment with Avelox was also associated with significantly higher rates of bacterial eradication, a reduced need for additional antibiotics to achieve clinical success, and a significantly prolonged interval between two exacerbations, 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 unique because it is the first antibiotic trial in AECB to examine these endpoints together in one study," said Wilson. "And the resulting picture of outcomes in the AECB patient is one of the most complete and informative we have ever seen."
MOSAIC Study Results
Avelox demonstrated a significantly higher clinical cure rate (70.9% vs. 62.8% in the comparator arm) and a significantly higher bacteriological eradication rate (91.5% vs. 81% in the comparator arm). Significantly fewer patients who took Avelox required additional post-therapy antibiotics to achieve clinical resolution of AECB (7.6 % of Avelox patients vs. 14.1% of patients taking standard therapy in the "intent-to-treat" population and 8.8% Avelox vs. 14.8% 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 Study Design
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 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 (symptom improvement) at seven-to-ten days following treatment.
AECB: A Serious And Growing Health Concern
Chronic bronchitis accounts for approximately 85% of all global cases of chronic obstructive pulmonary disease (COPD), which the World Health Organization (WHO) estimates as the fourth leading cause of death worldwide.
Long-term smoking is the most common cause of COPD, responsible for over 90 percent of all cases. A smoker is ten times more likely to die of COPD than a non-smoker. Other air pollutants and genetic factors may also play a role in determining COPD susceptibility. Chronic bronchitis is often neglected until it is in an advanced state, because people dismiss it as "smoker’s cough" and do not go to their doctor until irreversible damage has been caused.
About Avelox
In Europe, Avelox tablets are approved to treat non-severe Community Acquired Pneumonia (CAP), adequately diagnosed Acute Bacterial Sinusitis (ABS) and Acute Exacerbations of Chronic Bronchitis (AECB).
About Bayer HealthCare
Bayer HealthCare is part of the worldwide operations of Bayer, a subgroup of Bayer AG. Bayer HealthCare is one of the world's leading innovators in the health care and medical products industry.
Bayer HealthCare combines the global activities of the business groups of Bayer AG in the fields of Biological Products, Consumer Care, Diagnostics, Animal Health and Pharmaceuticals. More than 34,000 employees support the worldwide operations of Bayer HealthCare.
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