Randomized Controlled Trial on the Efficacy of Olfactory Cleft Steroid Drops in Patients With Chronic Rhinosinusitis With Olfactory Cleft Obstruction

Olfactory dysfunction is one of the most common clinical symptoms in patients with chronic rhinosinusitis (CRS), affecting approximately 60%-80% of individuals with CRS. This condition significantly impairs quality of life and is associated with systemic health issues such as depression and nutritional imbalances. The olfactory cleft, a critical anatomical region housing the olfactory neuroepithelium, is often obstructed in CRS patients due to nasal polyps or mucosal hypertrophy, leading to conductive olfactory dysfunction.

Current first-line treatments for CRS, including oral or intranasal corticosteroids, have limitations. Oral steroids pose systemic side effects, while standard nasal sprays often fail to deliver adequate drug concentrations to the olfactory cleft. In contrast, targeted hormone nasal drops may achieve higher efficacy by directly addressing localized inflammation and edema in the olfactory cleft. Preliminary studies suggest that fluticasone nasal drops can reduce the need for sinus surgery in patients with CRS unresponsive to conventional sprays. However, no randomized controlled trials have systematically evaluated the efficacy of olfactory cleft-targeted hormone drops in improving olfactory function in CRS patients with confirmed olfactory cleft obstruction.

In this study, investigators planned to enroll 54 patients with olfactory cleft obstruction and assign them to one of two treatments: olfactory cleft-targeted steroid nasal drops or conventional nasal sprays. This study aims to investigate the efficacy and underlying mechanisms of olfactory cleft-targeted steroid nasal drops in improving olfactory function.