PMID- 25941130 OWN - NLM STAT- MEDLINE DCOM- 20151016 LR - 20150505 IS - 0026-4946 (Print) IS - 0026-4946 (Linking) VI - 67 IP - 3 DP - 2015 Jun TI - Efficacy and safety of a medical device in reducing nasal obstruction in allergic children. PG - 239-43 AB - AIM: 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 beta-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. CONCLUSION: 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. FAU - Passali, D AU - Passali D AD - Department of Otolaryngology, University of Siena, Siena, Italy - d.passali@virgilio.it. FAU - Passali, F M AU - Passali FM FAU - Loglisci, M AU - Loglisci M FAU - Cambi, J AU - Cambi J FAU - Bellussi, L M AU - Bellussi LM LA - eng PT - Journal Article PL - Italy TA - Minerva Pediatr JT - Minerva pediatrica JID - 0400740 RN - 0 (beta-Glucans) RN - 19F5HK2737 (Pantothenic Acid) RN - 1O6C93RI7Z (dexpanthenol) RN - 61163-25-5 (carboxymethyl-beta-1,3-glucan) RN - 6FO62043WK (Glycyrrhizic Acid) RN - EC 3.4.21.- (Lactoferrin) SB - IM MH - Administration, Intranasal MH - Adolescent MH - Child MH - Equipment Design MH - Female MH - Glycyrrhizic Acid/administration & dosage/adverse effects MH - Humans MH - Lactoferrin/administration & dosage/adverse effects MH - Male MH - Nasal Obstruction/*drug therapy/etiology MH - Pantothenic Acid/administration & dosage/adverse effects/analogs & derivatives MH - Pilot Projects MH - Prospective Studies MH - Rhinitis, Allergic/complications/*drug therapy MH - Severity of Illness Index MH - Statistics, Nonparametric MH - Treatment Outcome MH - beta-Glucans/administration & dosage/adverse effects EDAT- 2015/05/06 06:00 MHDA- 2015/10/17 06:00 CRDT- 2015/05/06 06:00 PHST- 2015/05/06 06:00 [entrez] PHST- 2015/05/06 06:00 [pubmed] PHST- 2015/10/17 06:00 [medline] AID - R15Y2015N03A0239 [pii] PST - ppublish SO - Minerva Pediatr. 2015 Jun;67(3):239-43.