A randomized controlled trial comparing a xyloglucan-based nasal spray with saline in adults with symptoms of rhinosinusitis
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Published on: April 8, 2013
Alessandro Allegrini1, Daniele Pavone1, Fulvio Carluccio2
1a FourPharma CRO Srl , Colleferro ( RM ), Italy.
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.
