Efficacy and safety of Momate Rhino (mometasone furoate nasal spray in the form of a metered) in adult patients with perennial allergic rhinitis: a randomized multicentre open clinical study

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Abstract

Intranasal glucocorticosteroids, having high efficacy with respect to nasal symptoms, are recommended as a 1-st line treatment in patients withmoderate-severe seasonal and perennial allergic rhinitis. The aim of the present study is assessment of efficacy, safety and tolerability of Momate Rhino (dosing nasal spray) manufactured by “Glenmark Pharmaceuticals Ltd.” (India) in comparison with original mometasone furoate (dosing nasal spray) in adult patients with perennial allergic rhinitis. 120 patients, 18-65 years old, diagnosed with perennial allergic rhinitis, with medical history not less than 2 years, were randomized in open multicentre clinical study in parallel groups, conducted in 6 clinical centers of the Russian Federation during the period from 15.10.2013 till 29.07.2014. The tested pharmaceutical product Momate Rhino (dosing nasal spray) showed good clinical efficacy, compared to original mometasone furoate (dosing nasal spray). Both variants of therapy guaranteed evident decrease of overall estimate of nasal symptoms severity by the end of treatment period (after 4 weeks of therapy): 1.97±2.49 in control group, receiving original mometasone furoate (dosing nasal spray) and 1.64±2.18 in basic group, receiving the tested pharmaceutical product Momate Rhino. Both products caused evident decrease of nasal symptoms overall estimate after 4 weeks of therapy: 0.70±2.05 in control group and 0.40±1.06 in basic group (Momate Rhino). No statistically significant differences between the groups were found out. Upon completion of therapy, 52 (86.7%) patients of the group, treated with Momate Rhino, estimated the therapy as “very good” and “excellent”. Medical researchers estimated therapy in Momate Rhino group as “very good” and “excellent” in 52 (86.7%) patients, as well. The tested pharmaceutical products showed high safety and good tolerance. Thereby, the research results proved that the tested pharmaceutical product Momate Rhino, dosing nasal spray, produced by “Glenmark Pharmaceuticals Ltd.” (India) has, at least, equal efficacy and safety in comparison with original mometasone furoate (dosing nasal spray).

About the authors

N. M Nenasheva

Russian Medical Academy of Postgraduate Education of the Ministry of Health of the Russian Federation

Email: 1444031@gmail.com
д-р мед. наук, проф. каф. клинической аллергологии ФГБОУ ДПО РМАПО 125993, Russian Federation, Moscow, ul. Barrikadnaia, d. 2/1

N. I Ilina

Institute of Immunology

д-р мед. наук, проф., зам. дир.- глав. врач клиники ФГБУ ГНЦ Институт иммунологии 115478, Russian Federation, Moscow, Kashirskoie sh., d. 24, str. 2

N. G Berdnikova

I.M.Sechenov First Moscow Medical University of the Ministry of Health of the Russian Federation

канд. мед. наук, доц. каф. клинической фармакологии и пропедевтики внутренних болезней ФГБОУ ВО Первый МГМУ им. И.М.Сеченова 119991, Russian Federation, Moscow, ul. Trubetskaia, d. 8, str. 2

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