Background: Nasya/Prevalin is a natural, drug-free nasal spray for treatment and prevention of allergic rhinitis. Because of its thixotropic property, it forms a barrier on the nasal mucosa, preventing allergen contact. This study assesses the clinical efficacy and safety of Nasya/Prevalin in a nasal provocation test with house dust mite allergens.
Methodology/principal: In this randomised, double-blind, placebo-controlled trial, 20 subjects suffering from allergic rhinitis because of house dust mite allergens received a single dose of Nasya/Prevalin or saline spray before allergen challenge. Total nasal symptom score and total ocular symptom score were assessed 15, 30, 60, 75, 90, 120 and 240 min after challenge. Further, the appearance of the mucosa was examined by rhinoscopy.
Results: A single treatment with Nasya/Prevalin led to a significant reduction of TNSS at 60, 75 and 90 min after dust mite allergen challenge as compared with placebo (pVCAS = 0.021, pVCAS = 0.035, pVCAS = 0.036, respectively). Mucosa changes assessed by the rhinoscopic score (on swelling, secretion and colour) were significantly worse in the placebo group compared with the Nasya/Prevalin group (P = 0.033). Nasya/Prevalin was well tolerated, and the safety was comparable with placebo.
Conclusions: Treatment with Nasya/Prevalin was effective in preventing allergic reactions induced by dust mite allergen challenge.
Keywords: allergic rhinitis; allergy prevention; clinical trial; placebo-controlled; randomised.
© 2013 John Wiley & Sons Ltd.