Nasal obstruction as a key symptom in allergic rhinitis: efficacy and safety of a medical device in children.
BACKGROUND
Allergic rhinitis (AR) is a global health problem that has increased rapidly in prevalence over the past few decades. Nasal congestion, which represents a cardinal symptom of AR, appears to be difficult to treat and, especially for pediatric population, therapies that are both well tolerated and effective in relieving nasal congestion are needed. The aim of the present study was to evaluate the safety and clinical effectiveness of the medical device (lactoferrin, carboximetil β-glucan, D-panthenol, dipotassium glycyrrhizinate) in reducing the allergic rhinitis symptoms.


METHODS
A multicenter prospective study with a pre-post design was performed consecutively enrolling 100 pediatric patients of both genders affected by persistent AR. Patients received 2 puffs into each nostril 2 times a day over the course of 4 weeks. The severity of AR symptoms, as measured by VAS score, was assessed before and after treatment. The main outcomes were improvement in each symptom score and in overall symptom burden (as measured by average symptom scores). Differences in symptoms scores measured before and after treatment were compared using paired-sample Wilcoxon signed rank test. The proportion of participants with adverse effects attributed to the treatment was also computed.


RESULTS
All considered symptoms, including nasal congestion, significantly improve after treatment (p<0.001), while only 9 patients suffered adverse effects (itch, burning sensation, dryness).


CONCLUSIONS
These results confirm the efficacy and safety of this medical device in pediatric population.
Department of Otolaryngology, University of Siena, Italy.
Desiderio
D
Passali
Luisa Maria
LM
Bellussi
Dario
D
Gregori
Maria
M
Lauriello
Francesco Maria
FM
Passali
Giulio Cesare
GC
Passali
D000281:Administration, Intranasal / Q000295:instrumentation*; D000293:Adolescent; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D002648:Child; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D019695:Glycyrrhizic Acid / Q000008:administration & dosage; D006801:Humans; D007781:Lactoferrin / Q000008:administration & dosage; D008297:Male; D015508:Nasal Obstruction / Q000188:drug therapy* / Q000209:etiology; D010205:Pantothenic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D065631:Rhinitis, Allergic; D012221:Rhinitis, Allergic, Perennial / Q000150:complications*; D047071:beta-Glucans / Q000008:administration & dosage
D018926:Anti-Allergic Agents; D000890:Anti-Infective Agents; D000893:Anti-Inflammatory Agents; D047071:beta-Glucans; D010205:Pantothenic Acid; C007288:dexpanthenol; D019695:Glycyrrhizic Acid; D007781:Lactoferrin