Efficacy and safety of a medical device in reducing nasal obstruction in allergic children.
OBJECTIVE
Despite the availability of a number of pharmacological options, relief of allergic rhinitis (AR) symptoms, especially nasal obstruction, is often limited and local and systemic adverse reactions are not infrequent. The main aim of the present pilot study was to provide subjective and objective evidence of the clinical efficacy in reducing symptoms and safety of a medical device-Grip stop DMG (lactoferrin, carboximetil β-glucan, D-panthenol, dipotassiumglycyrrhizinate) in children affected by allergic rhinitis.


METHODS
A prospective study with a pre- and post-design has been performed consecutively enrolling 50 pediatric both genders patients affected by persistent AR. Patients received 2 puffs into each nostril twice a day over the course of 4 weeks. The severity of AR symptoms was assessed subjectively as measured by a 0 to 5 Visual Analog Scale, and objectively through active anterior rhinomanometry (AAR) and by means of the evaluation of mucociliary transport time (MCTt). Differences in symptoms scores measured before and after the treatment were compared using Paired-Sample Wilcoxon Signed Rank Test. Proportion of participants with adverse effects attributed to the treatment was computed. The relationship between the subjective score and the AAR and MCT measurements was also assessed.


RESULTS
All considered symptoms, including nasal congestion, significantly improved after treatment (P<0.001), while only 1 patient suffered from moderate adverse effects.


CONCLUSIONS
Results confirm efficacy and safety of this device used in the pediatric population. As previously reported in the scientific literature, also in our study, patient's perception of nasal symptoms corresponded with objective testing.
Department of Otolaryngology, University of Siena, Siena, Italy - d.passali@virgilio.it.
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D
Passali
F M
FM
Passali
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M
Loglisci
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Cambi
L M
LM
Bellussi
D000281:Administration, Intranasal; D000293:Adolescent; D002648:Child; D004867:Equipment Design; D005260:Female; D019695:Glycyrrhizic Acid / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007781:Lactoferrin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D015508:Nasal Obstruction / Q000188:drug therapy* / Q000209:etiology; D010205:Pantothenic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D010865:Pilot Projects; D011446:Prospective Studies; D065631:Rhinitis, Allergic / Q000150:complications / Q000188:drug therapy*; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D047071:beta-Glucans / Q000008:administration & dosage / Q000009:adverse effects
D047071:beta-Glucans; D010205:Pantothenic Acid; C007288:dexpanthenol; C029933:carboxymethyl-beta-1,3-glucan; D019695:Glycyrrhizic Acid; D007781:Lactoferrin