A double-blind, placebo-controlled, randomized clinical study of the effects of vardenafil on human nasal patency.

Abstract

Background: Vardenafil, a selective phosphodiesterase 5 (PDE5) inhibitor, may affect nasal patency because of its adverse-effect profile. This double-blind, placebo-controlled, randomized clinical study sought to assess the effect of vardenafil on nasal patency in patients at a university hospital.

Methods: Nasal patency was assessed using a visual analog score and by measuring the minimum cross-sectional areas (MCAs) and nasal cavity volumes with acoustic rhinometry in 14 subjects before and after administration of vardenafil. Measurements were repeated after administration of a local decongestant spray.

Results: There was no statistically significant difference between the nasal cavity volumes, MCA, and visual analog scale (VAS) scores before and after the administration of placebo. However, there was a significant increase in the nasal cavity volumes, MCAs, and VAS scores after application of the local decongestant. A significant correlation was found between MCAs and VAS scores (r = 0.96; p < 0.001). After administration of vardenafil, there was a significant increase in the degree of subjective sense of nasal obstruction as measured by VAS scores. Total nasal volumes showed a significant decrease (p < 0.05). The congestion effect induced by the vardenafil was reversed after application of the local decongestant spray, and a significant increase in cross-sectional areas was noted. In the vardenafil group, a significant increase in MCA, total volume, and VAS scores was observed after application of the local decongestant (p < 0.05).

Conclusion: Objective and subjective nasal obstruction after administration of vardenafil was significantly higher in this study than in previously reported studies. The effect of congestion can be reversed by local decongestants. The role of PDE5 inhibitors in nasal physiology merits additional investigation.