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Pivotal Data Showed SYMBICORT(R) Improved Lung Function in Adults with COPD
Date:10/29/2008

Data also found SYMBICORT opened airways in less than 15 minutes

WILMINGTON, Del., Oct. 29 /PRNewswire-FirstCall/ -- Data presented today from two pivotal efficacy and safety trials, SHINE and SUN, demonstrated that SYMBICORT(R) (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol significantly improved lung function and was well-tolerated in patients with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) relative to budesonide and formotorol administered alone, and placebo.(1,2,3,4) Both trials showed safety profiles consistent with the established profiles in asthma for each product.(2,4) In addition, an analysis of these trials showed that patients receiving SYMBICORT achieved a bronchodilatory effect, or opening of the airways, similar to formoterol DPI, and a more rapid effect than that achieved by either budesonide pMDI or placebo.(5) Results were presented today at CHEST 2008, the 74th annual international scientific assembly of the American College of Chest Physicians, held in Philadelphia, October 25-30, 2008.

In April 2008, AstraZeneca submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for SYMBICORT for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. SYMBICORT is a combination therapy currently indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older.(6) SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of asthma.(6)

"Results of the SHINE and SUN trials demonstrated that SYMBICORT improved lung function and was well-tolerated by study patients with COPD,(1,2,3,4) and if approved by the FDA, it could offer a new treatment option for the millions of Americans suffering from this debilitating disease," said lead investigator Donald Tashkin, M.D., of the University of California, Los Angeles (U
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SOURCE AstraZeneca
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