AstraZeneca (NYSE: AZN) announced today that results from TITAN, a 12-week study of SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol in African American patients with moderate to severe persistent asthma, showed significant improvement in lung function for patients taking SYMBICORT compared with those using budesonide alone. Safety and efficacy results from the TITAN study are consistent with previous studies conducted among predominantly Caucasian patients taking SYMBICORT. The study results were presented at CHEST 2010, the 76th annual meeting of the American College of Chest Physicians in Vancouver, British Columbia.
SYMBICORT is a combination asthma medication that contains both an inhaled corticosteroid (ICS) (budesonide) and a long-acting beta-agonist (LABA) (formoterol), and 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 Americans are approximately 20 percent more likely to have been diagnosed with asthma in their lifetime compared to Caucasians, and TITAN is one of the few asthma studies to examine a product like SYMBICORT in African American patients alone," said Dr. Ubaldo Martin, Director of Clinical Research at AstraZeneca.
Results from the 12-week TITAN study showed:
- Patients experienced greater improvement in predose FEV1 from baseline to the mean during the treatment period with SYMBICORT compared to budesonide (primary variable, P<.008)
- Improvements in morning and evening peak expiratory flow (PEF) were significantly greater from baseline through the end of treatment for patients using SYMBICORT compared to budesonide (P<.001)
- The most common adverse events (greater than or equal to 3% total) for patients receiving SYMBICORT or budesonide were headache, nasopharyngitis, and upper respiratory tract infection; most adverse events were mild to moderate in intensity
- The incidence of treatment-related adverse events was low (SYMBICORT, 1.3%; budesonide, 0.6%). There were no deaths among patients participating in the study.