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

ntial lung infections (e.g., bronchitis) was slightly higher in the active treatment groups compared to placebo.(4)

-- The most common drug-related adverse events were oral candidiasis, dysphonia and muscle spasms.(4)

Onset of Bronchodilation Results (Abstract 302)

An analysis of the data from the SHINE (Study I) and SUN (Study II) trials assessed the onset of bronchodilation, defined as the time to achieve 15 percent or greater improvement in FEV1, within the 1,109 study participants ages 40 years and older with moderate to very severe COPD for six and 12 months, respectively.(5) Study results include:

-- Onset of bronchodilation was significantly (P<.001; Wilcoxon rank sum test) earlier for patients receiving both doses of SYMBICORT (160/4.5 and 80/4.5 mcg) and formoterol compared with placebo in both studies.(5) Onset also was significantly earlier for both doses of SYMBICORT versus budesonide (assessed in Study I only).(5)

-- Median time (minutes) to 15 percent FEV1 improvement was as follows: SYMBICORT 160/4.5 mcg (6.8 [I]; 4.2 [II]), SYMBICORT 80/4.5 mcg (4.9 [I]; 4.8 [II]) and formoterol (9.0 [I]; 6.0 [II]).(5)

-- The percentages of patients achieving Greater Than or Equal To 15 percent FEV1 improvement within 15 minutes post-dose were as follows: SYMBICORT 160/4.5 mcg (58.6% [I]; 72.7% [II]), SYMBICORT 80/4.5 mcg (60.8% [I]; 70.2% [II]), budesonide (19.8% [I]), formoterol (61.5% [I]; 60.5% [II]), and placebo (13.0% [I]; 13.6% [II]).(5)

-- Compared with the day of randomization, the median time to onset of bronchodilation for SYMBICORT was maintained at treatment end in both studies, but increased in the formoterol group.(5)

About COPD

More than 12 million people in the United States suffer from COPD, and it is the fourth leading cause of death in the nation.(8) Some estimates also suggest that 12 million more people have COPD but remain undiagnosed.(8) COPD is a disorder encompassing two serious
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SOURCE AstraZeneca
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