Long-term Efficacy of Narivent® in the Treatment of Nasal Congestion



Valerio Damiani, Angelo Camaioni, Claudio Viti, Giulia Schillani, Francesca Foltran, Antonella Silvia Scire, Giada Morpurgo, Dario Gregori
1 ENT Department San Giovanni Addolorata Hospital, Rome, Italy
2 Department of Life Sciences, University of Trieste, Italy
3 Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Italy
4 Zeta Research Srl, Trieste, Italy


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© 2012 Damiani et al.;

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Correspondence: * Address correspondence to this author at the Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic and Vascular Sciences, Via Loredan, 18, 35121 Padova – Italy. Tel: +39 049 8275384; Fax: +39 02 700445089; E-mail: dario.gregori@unipd.it


Abstract

Rationale and aim:

Nasal congestion is a common symptom in allergic and non-allergic rhinitis, rhinosinusitis and nasal polyposis. Although various pharmacotherapy options exist, no agent is universally efficacious. The aim of this study was to evaluate the clinical effectiveness efficacy of Narivent®, which is an osmotically acting medical device with anti-oedematous and anti-inflammatory effects, in a long-term (30 days) treatment.

Methods:

A single-centre prospective study with a pre-post design was conducted with consecutive enrolment in an Italian Otolaryngology Department of 56 both genders patients with persistent nasal congestion.

Patients received 2 puffs of Narivent® into each nostril 2 times a day over the course of 4 weeks. The severity of symptoms was assessed subjectively as measured by a 0 to 10 visual analogue scale (VAS) and the presence/absence of symptoms and signs. Differences in subjective and objective severity measures before and after treatment were compared using Paired-Sample Wilcoxon Signed Rank Test.

Results:

A significant improvement after treatment (p<0.001) has been recorded for the main subjective symptoms and objective signs (overall symptom burden, nasal congestion, cephalea, rhinorrhea, hyposmia, turbinates hypertrophy, mucosa status).

Conclusion:

Study results confirm the efficacy of Narivent® in treating nasal congestion over a 4 weeks period.

Keywords: Persistent nasal congestion, Osmotically acting medical device, Anti-oedematous activity.