Pivotal Data Showed SYMBICORT(R) Improved Lung Function in Adults with COPD

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 (UCLA). "Data from these trials also showed that a greater percentage of patients achieved a 15 percent improvement in FEV1 within 15 minutes with SYMBICORT as compared to budesonide and placebo on the day of randomization and end of treatment."(5)

SHINE Study Results (Abstracts 298 and SHINE Safety)

The efficacy and tolerability of SYMBICORT was assessed in a six-month, randomized, double-blind, multicenter trial evaluating 1,704 patients ages 40 years and older with moderate to very severe COPD.(1,2) After two weeks of treatment based on previous therapy (inhaled corticosteroids (ICS) and short-acting bronchodilators were allowed), patients were then randomized to receive twice-daily treatment with two inhalations of SYMBICORT pMDI 160/4.5 micrograms (mcg), SYMBICORT pMDI 80/4.5 mcg, budesonide pMDI 160 mcg + formoterol DPI 4.5 mcg, budesonide pMDI 160 mcg, formoterol DPI 4.5 mcg or placebo.(1,2) Study results include:

-- Both SYMBICORT doses (160/4.5 and 80/4.5 mcg) demonstrated a significantly greater improvement from baseline in pre-dose forced expiratory volume in one second (FEV1) (P Less Than or Equal To .001) and one-hour post-dose FEV1 compared with budesonide (P