Potency of Momate Rhino Advance medication in the patients with the seasonal allergic rhinitis: the results of randomized open multicenter clinical test

Abstract

Intranasal corticosteroids and antihistamines form the basis of pharmacotherapy of allergic rhinitis (AR), however, combination therapy with these medications is needed quite frequently, especially in patients with seasonal AR. The objective of this study was to evaluate the efficacy, safety and tolerability of Momate Rhino Advance (the fixed combination of 140 µg Azelastine Hydrochloride + 50 µg Mometasone Furoate) in comparison with the original medications of Azelastine Hydrochloride and Mometasone Furoate taken in combination from separate devices, with respect to nasal (TNSS) and non-nasal (TNNSS) rhinitis symptoms in case of intranasal application of these medications for 14 days in adult patients with seasonal rhinitis. A total of 220 patients aged 18 to 65 years with a determined diagnosis of seasonal AR and with moderate/severe symptoms were randomized in an open, parallel-group, multicenter clinical test made in 16 centers in the Russian Federation at the period of April through September 2014. As a result of the therapy in patients treated with the tested medication and the reference medications, a significant decrease both in nasal symptoms, as measured according to TNSS scale (in average, by 89,6% as against the initial visit, p < 0,05), and non-nasal symptoms assessed using TNNSS (in average, by 92,8% as against the initial visit, p < 0,05) was noted. The analysis of the life quality of patients, estimated using a standardized questionnaire RQLQ, proved a significant positive trend as a result of the tested medication therapy and the reference medications therapy (p < 0.05). No difference was revealed between the tested medication and the reference medications in terms of reduction of nasal and non-nasal symptoms of seasonal AR and improvement of the patients’ life quality. All the tested medications exhibited high level of safety and tolerability. Therefore, the test results proved that the tested medication Momate Rhino Advance (a fixed combination of 140 µg Azelastine Hydrochloride + 50 µg Mometasone Furoate, Glenmark Pharmaceuticals Ltd., India) in the form of nasal spray possesses the efficacy and safety compared with the original medications of Azelastine Hydrochloride – nasal spray, and Mometasone Furoate – nasal spray, applied from the separate devices. BID was determined the optimal dosing schedule of Momate Rhino Advance.