The Open Medical Devices Journal

2012, 4 : 73-79
Published online 2012 September 20. DOI: 10.2174/1875181401204010073
Publisher ID: TOMDJ-4-73

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 and Dario Gregori
Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic and Vascular Sciences, Via Loredan, 18, 35121 Padova – Italy.

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.