1. In this randomized controlled trial, inhaled fluticasone furoate did not shorten the time to recovery for non-hospitalized patients with mild-to-moderate coronavirus disease 2019 (COVID-19) compared to a placebo.
2. Adverse events were not common in the fluticasone furoate or the placebo group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: As the COVID-19 pandemic continues, ongoing efforts are being made to prevent disease transmission and lower the risk of progression to severe disease. Although vaccinations remain the cornerstone of these efforts and effective antiviral agents are now available, there remain accessibility concerns to these therapies in low- and middle-income countries. The systemic glucocorticoid dexamethasone has demonstrated efficacy in treating COVID-19. However, evidence for inhaled glucocorticoids remained inconsistent. This study was a randomized placebo-controlled trial to assess the effectiveness of inhaled fluticasone furoate in treating outpatients with mild-to-moderate COVID-19. Compared to a placebo, treatment with a once-daily dose of inhaled fluticasone furoate did not shorten the time to COVID-19 recovery, nor did it reduce the rates of urgent care or emergency room visits or hospitalization. Both trial groups reported similarly low rates of adverse events. The study was limited by the underrepresentation of persons of color and heterogeneity in placebo formulations (oral or inhaled). These results demonstrated a lack of efficacy of inhaled fluticasone furoate as an outpatient treatment for COVID-19.
Click here to read the study in NEJM
In-Depth [randomized controlled trial]: The current study was a randomized, double-blind, placebo-controlled trial to investigate the efficacy of inhaled fluticasone furoate in treating outpatients with COVID-19. Adult patients 30 years of age or older who were not hospitalized and had at least two acute infection symptoms for no more than seven days before enrollment were eligible for inclusion. Exclusion criteria included pregnancy, breastfeeding, and recent use of other glucocorticoids. In total, 1,277 participants were randomized 1:1 to receive inhaled fluticasone furoate 200mg once daily or placebo for 14 days. The primary outcome was the time to sustained recovery, defined as reaching three consecutive days without COVID-19 symptoms. Secondary outcomes included a composite of urgent-care or emergency department visits, hospitalizations, or death. No significant difference in time to recovery was observed between the fluticasone furoate and the placebo groups (hazard ratio, 1.01; 95% Credible Interval [CI], 0.91-1.12; posterior probability of benefit, 0.56). There were no deaths, and hospitalizations only occurred in three patients in each group. The composite outcome of urgent-care or emergency department visits or hospitalizations occurred at similar rates in both groups (hazard ratio, 1.9; 95% CI, 0.9-3.5). Subgroup analysis did note that among unvaccinated patients, fluticasone furoate recipients had a longer time to recover, suggesting a variable response to treatment depending on vaccination status. These results demonstrated that inhaled fluticasone furoate did not offer clinical benefits for non-hospitalized patients with mild-to-moderate COVID-19.
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