Asthma disproportionately burdens people of color. In comparison to white patients, Black and Hispanic/Latino individuals visit the emergency room for asthma at higher rates, are hospitalized more often, and experience double the mortality rate. However, the medical community often fails to effectively represent these groups in clinical trials.
Now, a clinical trial spanning across 19 sites throughout the United States and Puerto Rico, including Yale School of Medicine, has focused on managing moderate-to-severe asthma in Black and Hispanic populations, looking specifically at the efficacy of inhaled corticosteroids (ICS) in treating symptoms. The investigators published the results of their PeRson EmPowered Asthma RElief (PREPARE) trial in The New England Journal of Medicine on February 26. The first author of the study was Elliot Israel, MD, of Brigham and Women’s Hospital in Boston.
“Most large asthma clinical trials include patients who are mostly Caucasian,” says Geoffrey Chupp, MD, professor of medicine (pulmonary), at Yale School of Medicine, who was an investigator in the trial. “We need race-specific data to ensure that we are treating all patients the right way.”
Asthma symptoms and treatments
Asthma symptoms, including chest tightness, coughing, and shortness of breath, are often a sign of inflammation in the airway. In addition to treating asthma with a bronchodilator, a medication that helps open the airway through relaxing the layer of muscle around the airway, clinicians now recognize the added benefit of also using anti-inflammatory medication, inhaled steroids (ICS), at the same time.
“These medications treat the underlying cause of symptoms—inflammation—as opposed to just treating the narrowed airways,” says Chupp.
Previous studies have shown that ICS are effective in treating asthma in broader populations, but there is a lack of research focusing on Black and Hispanic/Latino patients. The PREPARE trial was a pragmatic study conducted over four years, from November 2017 to April 2021, which followed 1201 Black and Hispanic/Latino patients with moderate-to-severe asthma.
Most large asthma clinical trials include patients who are mostly Caucasian. We need race-specific data to ensure that we are treating all patients the right way.
Geoffrey Chupp, MD
Validating treatments for patients of color
Throughout the trial, patients either continued their usual care—using a rescue inhaler as a bronchodilator—or were given another ICS inhaler to use in conjunction with their typical treatment. After one initial instructional visit, patients completed 15 monthly questionnaires that evaluated symptom management. The research team made all materials available in Spanish.
In comparison with individuals who proceeded with usual treatment, patients treated with ICS showed significant improvement in the number of asthma exacerbations they experienced—a reduction of 15 percent—and patients also experienced fewer overall asthma symptoms and days of impairment. “With a fairly modest intervention, we can have a significant impact on asthma treatment outcomes in underrepresented groups,” says Chupp.
Disproportionate rates of asthma
The reasons for asthma disproportionately affecting people of color are many. As a result of systemic racism, they may be more likely to live in impoverished conditions with greater exposure to allergens, or they may have lower health literacy that impacts their treatment.
“It’s hard to pinpoint one specific reason, but due to higher rates of severe asthma and hospitalization among these groups of people, it’s really important that we put more focus on what can be done to help,” says Isabel Bazan, MD, a Yale instructor of medicine in the section of pulmonary, critical care & sleep medicine, who is focused on health disparities in chronic lung disease, who is part of the Yale Center for Asthma and Airways Disease. “Having evidence-based support that these treatments are beneficial for underrepresented groups is critical because they are so frequently not included in clinical trials.”
The results of the trial, says Chupp, will change the way clinicians treat patients. Through integrating ICS therapy with a patient’s use of a bronchodilator, patients with moderate-to-severe asthma, especially those from underrepresented communities, will experience better outcomes. “The long-term implications of our trial are very profound,” says Chupp. “It will fundamentally create a paradigm shift in our therapeutic approach to how we treat patients with asthma.”