[Efficacy and distribution pattern of the medical device Prima Difesa on rhinosinusal area]

Common cold is the commonest form of acute rhinitis and the first pathology of the upper airways. Viruses, the main responsible of this pathology, carry out their cytopathic effect on the ciliated cells of the airways mucosa. Mucociliary transport shows their dangerous effect. The aim of our study is to evaluate the effect of the medical device Prima Difesa on the functioning of the mechanism thanks to its composition and its distribution modality in the nasal cavities.

The present study has been performed on three groups of subjects with their informed consent: Group A (30 healthy subjects: 19 M, 11 F; 18-36 yrs, mean age: 29.1 yrs), Gruppo B (30 patients affected by rhinosinusal pathology: 7 M, 13 F; 19-38 yrs, mean age 30.7 yrs) and Group C (20 healthy subjects: 12 M, 8 F; 20-40 yrs, mean age: 32.2 yrs). The protocol of administration for the Group A and B, in order to evaluate the efficacy of Prima Difesa, consisted of 2 puff per nostril of Prima Difesa 4 times a day over 15 days. The follow-up of patients belonging to Grup A and Group B was articulated in three consecutive visits, each consisting of: anterior rhinoscopy, active anterior rhinomanometry, measurement of mucociliary transport (TMCt). The C patients underwent only one administration of the device to the extent of evaluating through endoscopy its distribution modality in the nasal cavities.

The results show that clinical effects, evaluated in term of improvement of MCTt and in term of decreasing of nasal resistance, are particularly clear in patients with alterations of these parameters caused by rhinosinusal pathologies. The device can reach the "key" areas of rhinosinusal pathologies that are: middle turbinate and osteomeatal complex. Beside, the percentage of diffusion, about 30% of the middle turbinate head, justifies its clinical effect.

The medical device Prima Difesa has resulted to be able in interfering with the correct maintenance and performance of the Mucociliary Transport mechanism, that represents an important aspecific machinery for the local defence of nasal mucosa by microbial injuries.