Researchers will enroll around 500 African-American children and adults who have asthma in a multi-center clinical trial to assess how they react to therapies and to explore the role of genetics in determining the response to asthma treatment.
This new clinical study, which will take place at 30 sites in 14 states, is aimed at understanding the best approach to asthma management in African-Americans, who suffer much higher rates of serious asthma attacks, hospitalizations, and asthma-related deaths than whites.
The Best African American Response to Asthma Drugs (BARD) study is under the auspices of the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health.
"This large-scale clinical effort is expected to provide new insights into how health care professionals can better manage asthma in African-Americans to improve outcomes," said Gary H. Gibbons, M.D., director of the NHLBI.
"BARD reinforces the institute's commitment to understand, reduce, and ultimately even eliminate the disparities in asthma outcomes observed in the African-American population compared to other Americans with asthma," added James Kiley, M.D., director of the NHLBI Division of Lung Diseases.
BARD will examine the effectiveness of different doses of inhaled corticosteroids (ICS) used with or without the addition of a long-acting beta agonist (LABA). ICS reduce inflammation and help control asthma in the long term.
LABAs relax tight airway muscles. This study will compare multiple combinations of medications and dosing regimens to assess the response to therapy. BARD will track whether children and adults respond similarly to the same treatment, and evaluate how genes may affect treatment response.
"While national asthma guidelines provide recommendations for all patients with asthma, it is possible that, compared with other groups, African-Americans respond differently to asthma medications," said Michael Wechsler, M.D., principal investigator for the BARD study and professor of medicine at National Jewish Health in Denver. "Our study is designed to specifically address how asthma should be managed in African-American asthma patients, both adults and children."
The BARD study is supported by NHLBI's AsthmaNet clinical trials network. BARD began enrolling patients on Feb. 10.