Altamira Therapeutics has reported that the NASAR clinical trial of Bentrio nasal spray for seasonal allergic rhinitis (SAR) has met its primary efficacy endpoint of change in mean reflective Total Nasal Symptom Score (rTNSS) over two weeks.
The rTNSS decreased in the Bentrio group from 6.9 points to an average of 5.0 points over the treatment period of 14 days and in the saline spray group from 6.9 to 6.2 points.
Altamira Therapeutics founder, chairman and CEO Thomas Meyer said: “Further, the NASAR results show for Bentrio a statistically significant and clinically highly relevant improvement in efficacy over the current standard of care saline nasal spray treatment.
“Whereas a saline nasal spray aims to rinse out allergen particles, Bentrio forms a thin protective layer which prevents contact of those particles with the nasal mucosa and helps to remove them through natural mucociliary clearance.
“As already demonstrated in a previous trial, Bentrio stays for about 3.5 hours within the nasal cavity where it can exert its protective effects.”
The randomised, controlled study enrolled 100 patients in Australia who were divided into a 1:1 ratio to self-administer either Bentrio or saline nasal spray three times per day for two weeks or when needed.
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By GlobalDataPatients with a baseline rTNSS of at least five points out of 12 were eligible to participate in the study.
In addition, Bentrio’s efficacy and tolerability were rated as good or very good by 63.5% and 73.5% of trial participants.
Formulated as a drug-free and preservative-free gel emulsion, Bentrio nasal spray protects against airborne viruses and airborne allergens such as pollen or house dust mites.