Nenasheva N.M., Ilina N.I., Fedoskova T.G. The effectiveness of intranasal corticosteroids and antihistamines combination – mometasone furoate and azelastine hydrochloride nasal spray in adults with seasonal allergic rhinitis (The results of clinical trial)

· RAJ №2-2016

Nenasheva N.M.1, Ilina N.I.2, Fedoskova T.G.2

1 Russian Medical Academy for Postgraduate Education, Moscow
2 Institute of Immunology, Moscow, Russia

Key words: mometasone/azelastine nasal spray, seasonal allergic rhinitis

Background. Intranasal corticosteroids and antihistamines are the basis of pharmacotherapy of allergic rhinitis
(AR). The aim of this study was to evaluate the efficacy, safety and tolerability of Momat Rhino Advance (fixed
combination of azelastine hydrochloride 140 mcg + mometasone furoate 50 mcg) intranasal spray in seasonal
rhinitis patients.
Materials and methods. Momat Rhino Advance was administered within 14 days in adults with seasonal AR in
comparison with the original azelastine hydrochloride and mometasone furoate, used in combination with each
other from separate devices against nasal (TNSS) and non -nasal (TNNSS) rhinitis symptoms. In total, 220 patients
18–65 years old with moderate/severe seasonal AR, were randomized in an open, parallel -group, multicenter
clinical trial conducted in 16 centers in the Russian Federation during the period from April to September 2014.
Results and conclusion. As a result of the study a marked decreasing of nasal symptoms using scale TNSS (in
89,6% relatively to the initial visit, p<0,05), and non- nasal symptoms using scale TNNSS (in 92,8% relatively to
the initial visit, p<0,05) was obtained. Quality of life index using a standardized questionnaire RQLQ, showed
a significant positive trend in treated patients with AR (p<0,05). There were no differences between the main
group and other groups of patients in relation to nasal and other symptoms of seasonal AR and quality of life
index. All studied drugs have shown high level of safety and tolerability.
Thus, there was no difference between Momat Rhino Advance (fixed combination of azelastine hydrochloride
140 mcg + mometasone furoate 50 mcg, Glenmark Pharmaceuticals Ltd., India) nasal spray efficacy and safety
in comparison with azelastine hydrochloride – nasal spray, and mometasone furoate nasal spray, applied from
the individual devices in seasonal allergic rhinitis patients. The optimum regimen of using of Momat Rhino
Advance was twice daily.