In a first-of-its-kind clinical trial, asthma researchers at University Hospitals Rainbow Babies & Children's Hospital (UH Rainbow) will evaluate treatment guidelines for African American children and young adults with asthma.
"Each year African Americans experience more asthma-related urgent care visits, hospitalizations and death rates compared to Caucasians," says James Chmiel, MD, Clinical Director of Pediatric Pulmonology at UH Rainbow and principal investigator of the UH Rainbow study site. Dr. Chmiel, who is also Associate Professor of Pediatrics at Case Western Reserve University School of Medicine, says one possible explanation is that African Americans respond differently to asthma therapies.
The study of Best African American Response to Asthma Drugs (BARD) will examine whether African Americans respond differently to asthma therapies compared to Caucasians and will help to identify the best add-on therapy based on the patients' age. Researchers are recruiting African American patients five years of age and older who have asthma. UH Rainbow is conducting this study as a member of nine partnerships known as AsthmaNet. AsthmaNet is a network of asthma researchers across the country conducting this and other asthma research studies, and is funded by the National Institutes of Health.
National asthma guidelines recommend increasing inhaled corticosteroids (ICS) or adding a long-acting beta agonist (LABA) to treat patients who have difficulty controlling symptoms on low doses of ICS. However, these guidelines are based on studies conducted in populations that were predominantly non-black. Evidence suggests African Americans may not respond to changes in asthma medications the same way other races do.
BARD will enroll several hundred patients nationally for 18 months. Study participants will receive low dose ICS, and if their asthma is inadequately controlled, they will receive four different treatments (low dose ICS plus LABA, medium dose ICS, medium dose ICS plus LABA, and high dose ICS) over four separate 14-week treatment periods.
"Results of the BARD study will allow for evidence-based recommendations for the use of asthma medications in African Americans, significantly impacting national asthma guidelines," says Dr. Chmiel.