SYMBICORT long-term comparative study data in African American asthma patients presented at ATS 2011

May 17 2011

AstraZeneca (NYSE:AZN) today announced results from a long-term study comparing SYMBICORT^® (budesonide/ formoterol fumarate dihydrate) Inhalation Aerosol 160/4.5 mcg with budesonide pressurized metered-dose inhaler (pMDI) 160 mcg in self-reported African American patients with moderate to severe persistent asthma. The data demonstrated that SYMBICORT treatment resulted in significant improvement in lung function compared to treatment with budesonide alone, and safety results indicated that patients in the SYMBICORT group had fewer exacerbations over the randomized study period compared to patients treated with budesonide. The incidence of adverse events (AEs) was similar between the two groups. The results were presented in a poster at the 2011 American Thoracic Society (ATS) International Conference in Denver.

SYMBICORT is a combination asthma medication that contains both an inhaled corticosteroid (ICS) (budesonide) and a long-acting beta-agonist (LABA) (formoterol). It is indicated for the treatment of asthma in patients 12 years of age and older not adequately controlled on a long-term asthma control medication, such as an ICS, or whose disease severity clearly warrants initiation of treatment with both an ICS and LABA.

"African American patients are disproportionately affected by asthma - asthma prevalence is higher for African Americans than for Caucasians," said Dr. Ubaldo Martin, Director of Clinical Research at AstraZeneca. "Data from this year-long study of SYMBICORT supports our understanding of the product's efficacy and safety in African American patients."

There have been few prior studies evaluating combination asthma treatment in specific ethnic populations at higher risk for asthma prevalence. Results from this 52-week study are consistent with safety and efficacy data from the TITAN study, a 12-week study of SYMBICORT in African American patients, and with previous SYMBICORT studies conducted among predominantly Caucasian patients.

Source: AstraZeneca