In a 52-week study in African-American patients with moderate-to-severe persistent asthma, the company found that headache, nasopharyngitis, sinusitis and viral upper respiratory tract infection were the most common adverse events, regardless of study drug relationship.
The study, published in the online edition of The Journal of Allergy & Clinical Immunology (JACI), however, did not find unexpected patterns of abnormalities in laboratory, electrocardiographic, or Holter monitoring assessments.
AstraZeneca associate medical director Frank Trudo said these findings provide important information about the use of Symbicort in African-American patients with persistent asthma, and may help guide healthcare professionals considering treatment therapies for their appropriate patients with asthma.
"This trial is part of AstraZeneca’s commitment to studying SYMBICORT in patient populations with disproportionate asthma prevalence," Trudo added.
The 52-week study results were similar to safety data from the TITAN study, a 12-week study of Symbicort in African-American patients.