A randomized controlled trial comparing a xyloglucan-based nasal spray with saline in adults with symptoms of rhinosinusitis.

BACKGROUND

This study assessed the efficacy, safety and tolerability of a xyloglucan-based nasal spray in the treatment of symptoms of rhinosinusitis.

METHODOLOGY

In this randomized, double-blind study, 40 patients with itching, nasal congestion or continuous sneezing and a Total Nasal Symptom Score (TNSS) of ≥8 were randomized to 2 weeks' treatment with a xyloglucan-based nasal spray ("xyloglucan") or a physiological saline nasal spray ("saline"). Assessments included the TNSS, rhinosinusitis severity index, nocturnal awakenings, use of rescue medication, safety and tolerability.

RESULTS

Baseline symptom scores were similar between groups. At treatment end, improvements from baseline were observed in both groups for TNSS (xyloglucan 58%; saline 35%, both p < .05) and number of nocturnal awakenings (p < .05). A significant improvement in the rhinosinusitis severity index was observed only with xyloglucan (p < .05). At treatment end, mean [SD] scores were significantly lower in the xyloglucan group versus the saline group for TNSS (3.60 [2.16] vs. 5.40 [2.64], p < .05), rhinosinusitis severity index (7.55 [1.19] vs. 6.45 [1.40], p < .05), and rhinorrhea and itching (both p < .05). No rescue medication was used. Both treatments were well tolerated.

CONCLUSIONS

A xyloglucan-based nasal spray provided greater relief of rhinosinusitis symptoms than a physiological saline spray and was well tolerated. Trial registration number (EUDRACT): 2014-000143-32.