Georgetown Awarded $23.6M to Study Treatments for Acute Rhinosinusitis
WASHINGTON (July 28, 2022) — The Patient-Centered Outcomes Research Institute (PCORI) has awarded a Georgetown University Medical Center research team led by Dan Merenstein, MD, professor of family medicine at Georgetown’s School of Medicine and professor of human science at the School of Health, $23.6 million in research funding to study treatments for acute rhinosinusitis.
Acute rhinosinusitis involves inflammation of the nose and sinus passages, most often caused by a viral or bacterial infection. Symptoms often include congestion, headaches, sinus pressure, facial pain and a green/yellow nasal discharge.
“Acute rhinosinusitis leaves people feeling miserable and desperate for relief, and their care providers eager to help,” says Merenstein, director of research programs for Georgetown’s Department of Family Medicine. “Unfortunately, in the absence of clinically proven treatments, providers often prescribe antibiotics. We want to know if there’s a better way to treat patients and alleviate symptoms quicker, while also figuring out who really benefits from antibiotics and should take them as soon as possible.”
In the U.S., one in seven adults every year is diagnosed with acute rhinosinusitis (totaling 30 million office visits), leading to antibiotics prescribed to one in five adults. In addition to antibiotics, nasal sprays such as intranasal corticosteroids (INCS), over-the-counter supportive treatment, or saline nasal irrigation (SNI) may help improve symptoms.
“Our study goal is to understand what treatment approaches are best at improving outcomes for patients,” Merenstein explains. “Do antibiotics really improve the course of symptoms, or are options such as nasal irrigation or nasal sprays with a corticosteroid more effective? We hope the information we learn in this study can be used by providers and those suffering from this tough to treat condition.”
Nawar M. Shara, PhD, director of biostatistics, informatics and data science at MedStar Health Research Institute, is co-investigator for the study. The research collaboration also involves investigators from the University of Washington, UCLA, Virginia Commonwealth University, Penn State and the University of Wisconsin.
Together, the investigators will recruit more than 3,700 people diagnosed with acute rhinosinusitis to the largest clinical trial of its kind to study various treatment approaches. The randomized clinical trial will compare outcomes among treatments with antibiotics, INCS, and antibiotics plus INCS. Some arms of the study will include a placebo.
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 health care decisions.
Merenstein’s study was selected for funding through a PCORI initiative to support large-scale, high-impact comparative effectiveness research trials in a multiphase format allowing for testing and refinement of the study approach. It was selected through a highly competitive review process in which patients, caregivers and other stakeholders joined scientists to evaluate the proposals. The study will involve an initial feasibility phase to maximize the likelihood of full trial success.
Merenstein’s award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.