Study to Address Unmet Treatment Needs in Condition Affecting Millions Worldwide

MONTE CARLO, MONACO, February 6, 2001 – Bayer HealthCare today announced the initiation of GIANT (Greatest International Antibiotic Trial), a global observational clinical trial to evaluate the impact of acute exacerbations of chronic bronchitis (AECB) on patients and communities, as well as the efficacy and safety of the antibiotic Avelox^® (moxifloxacin HCl). GIANT will examine an estimated 100,000 patients in more than 30 countries around the world, making it the largest clinical trial ever conducted in antibiotic research. Lead investigators of the trial represent major European countries and the United States. The announcement of the trial was made during the Third Forum on Respiratory Tract Infections in Monte Carlo, Monaco.

“Previous studies have demonstrated the superiority of Avelox compared to standard treatments such as amoxicillin and clarithromycin for AECB and also revealed an urgent need to better understand the progression of this disease and to reevaluate how AECB is treated,” said Prof. Delfino Legnani, Associated Professor in Pulmonary Diseases, University of Milan. "GIANT is designed to provide insight into the daily clinical practice treatment of AECB across a broad global patient population and to evaluate the role of Avelox in providing quick symptom relief and improved disease management.”

The need for more rapid symptom relief and better overall AECB management has been demonstrated by a recent six-country survey of 1,100 AECB patients conducted by Psyma International Medical Marketing Research. The study found that more than half (55%) of AECB patients want an antibiotic that provides faster symptom relief. The same survey also found that 67% of AECB patients have suffered symptoms (including coughing, fatigue, and shortness of breath) for more than six years. These symptoms can be so severe that 17% of survey respondents feared that AECB would "eventually cripple or kill" them.

"AECB remains a misunderstood and burdensome condition in many countries throughout the world," said Harald Landen, MD, PhD, Global Medical Development GIANT, Bayer HealthCare "These and other data point to the need for further multinational clinical research, like GIANT, to determine the impact of treatment on the course of AECB and how we can improve patient quality of life by effectively managing the condition with antibiotics."

About GIANT
GIANT is the first global trial of its kind to evaluate the complete course of AECB progression in patients affected by this debilitating disease. The study will be conducted in an outpatient setting and will allow investigators to gather patient case reports and detailed patient descriptions, including AECB history, risk factors and concomitant disease and medication. The large patient population will allow special analyses of different subsets of patients and epidemiological and demographic factors. The trial aims to provide the most comprehensive assessment of the AECB patient to date.

The study will examine the impact that treatment with Avelox has on AECB and determine how rapidly symptom relief occurs, how quickly patients return to normal daily activities after starting treatment and how often adverse events occur. Daily antibiotic intake and the amount of other medications being taken will also be observed. Additionally, the trial is designed to evaluate patients during six and 12-month follow-up periods to determine how AECB progresses after treatment and the frequency of new exacerbations.

GIANT will build on the findings of MOSAIC, a landmark clinical trial that demonstrated the superiority of Avelox over some standard seven-day treatments for AECB. MOSAIC showed that patients treated with Avelox for five days had significantly higher clinical cure rate, significantly more time between AECB episodes and required fewer antibiotics for the treatment of relapses during follow-up periods when compared to patients given a seven-day course of amoxicillin, clarithromycin or cefuroxime-axetil. MOSAIC was the first study of its kind to document baseline health status, include long-term monitoring and surveillance, and provide data on innovative endpoints such as “time to next exacerbation” and “need for follow-up antibiotic treatment.”

About AECB
In patients with chronic bronchitis, AECB is the sudden onset of increased mucus production, increased mucus purulence (pus content), increased cough and increased shortness of breath. Repeated episodes of AECB, which are often caused by bacterial infections, cause progressive lung damage and lead to deteriorating lung function over time.

Chronic bronchitis is a global problem affecting an estimated 17 million people in Europe and 14 million people in the United States. Chronic bronchitis accounts for approximately 85% of all global cases of chronic obstructive pulmonary disorder (COPD), which the World Health Organization (WHO) estimates as the fourth leading cause of death worldwide. The total financial burden of COPD amounts to nearly €50 billion in Europe and $40 billion in the United States.

About Avelox
In Europe, Avelox tablets are approved to treat Community Acquired Pneumonia (CAP), except severe cases, Acute Bacterial Sinusitis (ABS), adequately diagnosed, and Acute Exacerbation 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.

Our work at Bayer HealthCare is to discover and manufacture innovative products for the purpose of improving human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.

^Back to top