AstraZeneca 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 the 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.
SYMBICORT, a combination asthma medication that contains both an inhaled corticosteroid (ICS) (budesonide) and a long-acting beta-agonist (LABA) (formoterol), 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.
The 52-week, randomized, double-blind Phase3 study included 742 self-reported African American patients 12 years of age and older with moderate to severe persistent asthma. After two weeks of receiving two inhalations, twice daily of budesonide 160 mcg, patients were randomized to receive two inhalations, twice daily of SYMBICORT 160/4.5 mcg or two inhalations, twice daily of budesonide 160 mcg.2
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.
Release Date: May 16, 2011
Filed Under: Drug Discovery