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

Abstract

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.

Keywords:

• Nasal spray
• rhinitis
• rhinosinusitis
• saline
• xyloglucan

Note

Transparency

Declaration of funding

This study was funded by Novinthetical Pharma SA, Lugano, Switzerland.

Author contributions: All authors contributed significantly to the conception, design or execution of the study. All authors participated in drafting, reviewing and/or revising the manuscript, and all have approved its submission.

Declaration of financial/other relationships

A.A., D.P. and F.C. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

Writing and editorial assistance in the preparation of this article was provided by Content Ed Net (Madrid, Spain), with funding from Noventure SL, Barcelona, Spain.

Notes

1 Rhinosectan is a registered trade name of Novinthetical Pharma SA, Lugano, Switzerland