A study led by the Duke Clinical Research Institute (DCRI) in partnership with Vanderbilt University found no clinical benefit to taking fluticasone furoate for treatment of mild-to-moderate COVID-19 symptoms.
Fluticasone is an orally inhaled corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy. This medication is one of three repurposed medications currently being tested as a potential therapy in ACTIV-6 (The Randomized Trial to Evaluate Efficacy of Repurposed Medications). The nationwide, double-blind study found that the medication did now show benefits in the treatment of COVID-19 despite early public interest in the drug as a potential therapy.
“There was no evidence of improvement in time to recovery or reduction in hospitalizations in participants who took fluticasone versus those who took a placebo,” said Adrian Hernandez, MD, the study’s administrative principal investigator and executive director of the DCRI.
ACTIV-6 has enrolled nearly 5,000 participants from across the United States. The study is part of the National Institutes of Health-funded Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) and is led by the National Center for Advancing Translational Sciences (NCATS). The DCRI serves as the study’s clinical coordinating center, partnering with Vanderbilt University Medical Center as the study’s data coordinating center.
The findings were published in the New England Journal of Medicine on Sept. 21, 2023, marking the latest ACTIV-6 results publication. Results were initially released and posted on medRxiv, a pre-publication server, on July 13, 2022.
“Just like people can test for COVID at home, we’re looking at how to treat people with mild-to-moderate COVID at home,” said Susanna Naggie, MD, the DCRI principal investigator overseeing the study’s clinical coordinating center. “ACTIV-6 is really designed to do that. The study continues to enroll into other medication arms and may add additional arms as the study progresses.”
The fluticasone arm of the study opened in June 2021 and enrolled 1,127 participants across the United States in eight months. During the study, participants either took a dose of 200 mcg per day of fluticasone or used a matching placebo inhaler for 14 days.
“No safety concerns were identified in this arm of the study, confirming that fluticasone is safe to take as prescribed per the FDA for the treatment of asthma or other approved conditions,” said Naggie.
Fluticasone is not approved by the FDA to treat COVID-19 and should only be taken for COVID-19 as part of a clinical trial.
Members of the ACTIV-6 Executive Committee include Hernandez, Naggie, Stacey Adam, David Boulware, Sean Collins, Allison DeLong, Sarah Dunsmore, G. Michael Felker, George Hanna, Chris Lindsell, Matthew McCarthy, Gene Passamani, April Remaly, Elizabeth Shenkman, Thomas Stewart, Florence Thicklin, Rhonda Wilder, and Sybil Wilson.
COVID-19 Research at the DCRI
In addition to serving as the clinical coordinating center for ACTIV-6, the DCRI is also involved with other ACTIV studies, serving as the U.S. coordinating center for ACTIV-1, a COVID-19 master protocol study testing immune modulators, and participating in ACTIV-4, which is examining optimal use of oral anticoagulants to prevent COVID-19-associated blood clots.
The DCRI’s other COVID-19 projects aim to reduce transmission in schools and communities, maximize vaccine safety, and expand testing access in underserved communities.