The UNC site’s principal investigators are Michelle Hernandez, MD, professor in the UNC Department of Pediatrics, and Katrina Donahue, MD, MPH, professor and vice chair of research in the UNC Department of Family Medicine.
CHAPEL HILL, NC — The UNC School of Medicine has been selected to participate in a new study to examine the comparative effectiveness of asthma treatments. The project will focus on which of the two treatment types – inhaled steroids or specific antibiotics, alone or in combination – works best in different patients.
Asthma is a common chronic disease that affects more than 20 million Americans, and asthma exacerbations are the leading cause of missed school or work for children and young adults, according to the Centers for Disease Control and Prevention (CDC). Population surveys by the CDC indicate that despite continued advances in asthma therapies, the rate of exacerbations has declined only marginally over the past 20 years.
The Individualizing Treatment for Asthma in Primary Care (iTREAT-PC) study, funded by the Patient-Centered Outcomes Research Institute (PCORI), will test the interventions both alone and together in more than 3,000 people with asthma aged 12 years and older. Individuals are followed for 16 months to determine which therapy is most effective in which individuals. The UNC School of Medicine is one of 10 clinical partners in the United States participating in the study.
“We care for many children and adults whose asthma is difficult to control,” said Michelle Hernandez, MD, professor of pediatrics and UNC Site PI. “We are excited to participate in this study so that we can test novel, evidence-based and pragmatic asthma treatments that can reduce the burden of asthma for individuals of diverse backgrounds.”
Hernandez and Katrina Donahue, MD, MPH, professor of family medicine, will lead implementation activities in primary care clinics (Family Medicine, Internal Medicine, and Pediatrics) within the NC TraCS-supported practice-based research network, the North Carolina Network Consortium (NCNC). “
This study aligns directly with our network’s goal of answering pressing questions related to conditions commonly encountered in primary care,” Donahue said.
The iTREAT-PC trial will begin in January 2023 with an 18-month feasibility phase and the full trial will commence in July 2024. Participation in the study will be through the enrolling clinical sites, including the UNC School of Medicine.
The American Academy of Family Physicians (AAFP) in partnership with Penn State College of Medicine has been approved for a $31 million funding award by the Patient-Centered Outcomes Research Institute (PCORI). The iTREAT-PC study award has been approved pending the completion of a business and programmatic review by PCORI personnel and the issuance of a formal award contract.
PCORI is an independent non-profit organization authorized by Congress in 2010. Its mission is to fund research that provides patients, their caregivers, and clinicians with the evidence-based information needed to make more informed healthcare decisions. For more information on PCORI funding, visit www.pcori.org.
Michelle Hernandez, MD, is a professor of pediatrics in the Department of Allergy and Immunology. She is the pediatric and adolescent director of the North Carolina Network Consortium and is director of the Clinical Research Unit for the Children’s Research Institute.
Katrina Donahue, MD, MPH, is a professor and vice chair of research in the UNC Department of Family Medicine. She is a primary care physician and senior research fellow at the Cecil G. Sheps Center for Health Services Research at UNC-Chapel Hill. She is also co-director of the North Carolina Network Consortium and serves on the US Preventive Services Task Force.