Study assesses bronchitis impact

A renowned panel of experts has presented for the first time findings from the Middle East GIANT (Greatest International Antibiotic Trial) study and compared them with the latest available global data set.

The GIANT study - initiated by Bayer Schering Pharma - evaluates the impact of acute exacerbations of chronic bronchitis (AECBs) on patients, as well as the efficacy and safety of the antibiotic Avalox (moxifloxacin HCl) in the real-world setting.

A total of 46,891 valid patients were documented during the trial, of which 4,350 are from the Middle East region. The data clearly show that the quality of life of Middle East patients suffering from this weakening disease is tremendously affected.

On average, these Middle East patients experienced 2.8 acute exacerbations per year and each time their daily activities were negatively impacted for about four days.

Moreover, patients suffered from severe sleep disturbances during this debilitating disease phase. Effective antibiotic treatment is needed to minimise the impact of these acute attacks on patients. The antibiotic Avalox can help to reduce this burden.

Strictly-controlled clinical trials such as MOSAIC have already shown that it provides substantial benefits over standard antibiotics in the treatment of AECB: Moxifloxacin helped more patients return to their healthy state, but also extended the time interval between exacerbations.

"In the GIANT study we wanted to verify if these effects can also be seen in real life," explained Professor Antonio Anzueto.

"We think that the GIANT results are very impressive since Middle East patients treated with moxifloxacin suffered, on average, one day less from AECB compared to previous treatment. This is an obvious benefit for the patient."

When an acute exacerbation starts, glands in the bronchi produce more mucus than usual, which results in increased coughing as the body tries to clear it from the lungs.

In addition to developing a persistent cough, many patients will also experience acute breathlessness resulting in a significant decrease in their quality of life and sleep disturbance.

As well as causing acute symptoms, exacerbations also contribute significantly to the acceleration of the course of the disease over time. Therefore, early diagnosis and effective treatment is needed to successfully manage this disease.

The Middle East GIANT data demonstrates that treatment with moxifloxacin resulted in rapid overall improvement (including symptoms such as fever, sputum purulence, fatigue, sleep disturbance) in all severity groups (~70% at day 3, and ~95% at day five).

"97% of patients were very satisfied or satisfied with this effective therapy," said Dr Marc Miravitlles, "78.3 % of physicians even rated the overall effect of moxifloxacin as better than the previous therapy and 95.8% assessed efficacy as either very good or good. These results re-confirm the findings from clinical trials."