UNC School of Medicine participating in $31-Million asthma study

The UNC site lead 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.

Michelle Hernandez, MD and Katrina Donahue, MD, MPH

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 two treatment types – inhaled steroids or specific antibiotics, alone or together – works best in different patients.

Asthma is a common chronic disease affecting 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 ongoing advances in asthma therapies, exacerbation rates have dropped only marginally in the past 20 years.

The Individualizing Treatment for Asthma in Primary Care (iTREAT-PC) study, funded through the Patient-Centered Outcomes Research Institute (PCORI), will test the interventions both alone and together in more than 3,000 people with asthma age 12 and over. Individuals will be 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 across 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 new, evidence-based and pragmatic asthma treatments that can reduce the burden of asthma for individuals from 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 directly aligns with our network's goal to address pressing questions related to conditions commonly encountered in primary care," Donahue said.

The iTREAT-PC study will begin an 18-month feasibility phase in January of 2023, and the full-scale study will launch 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 completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI's funding, visit www.pcori.org.

Michelle Hernandez, MD, is a Professor of pediatrics in the Division 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 family physician and senior research fellow at the Cecil G. Sheps Center for Health Services Research at UNC-Chapel Hill. She is also the co-director of the North Carolina Network Consortium and serves on the U.S. Preventive Services Task Force.

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