Efficacy and safety of azoximer bromide (Polyoxidonium) in children aged from 1 to 12 years with ARI: The results of a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group study

Abstract

Purpose: To confirm the superiority of the therapeutic effect of topical use of azoximer bromide (Polyoxidonium) in comparison with placebo in children from 1 to 12 years of age with ARVI. Patients and methods: The study included 155 children: the main group consisted of 76 children with azoximer bromide, the comparison group consisted of 79 children with placebo included in the complex treatment. The study evaluated the dynamics of intoxication symptoms, symptoms of inflammation of the nasal mucous membrane, the total sum of all symptoms in points to 3, 5 and 8 days of treatment, the duration of the fever period as criteria for evaluation the effectiveness of therapy. Results: According to the study results, the efficacy of azoximer bromide use in the complex therapy of children from 1 to 12 years with ARVI can be stated. Inclusion of azoximer bromide in the complex treatment of ARVI in children as compared to placebo allows to control better the symptoms of intoxication, to reduce the severity of symptoms of “nasal discharge” and “nasal congestion” by the 5th day of therapy, to increase twice the number of patients with no symptoms of “Nasal discharge” by the 3rd and 5th days of therapy, to reduce the severity of infectious and inflammatory process. The number of adverse events on the background of azoximer bromide use is not statically significantly different from the number of adverse events on the placebo use background, which indicates the safety of azoximer bromide. Conclusion: Topical use of azoximer bromide in complex treatment of ARVI in children from 1 to 12 years is clinically effective and safe. *Correspondence to: TTatyana Ilyinichna Garashchenko, Federal State Budgetary Institution, The National Medical Research Center for Otorhinolaryngology for the Federal Medico-Biological Agency of Russia, Russia, Tel: +79162360009, +79169040100; E-mail: 9040100@mail.ru Galina Dmitrievna Tarasova, Research Department of the Federal State Budgetary Institution, The National Medical Research Center for Otorhinolaryngology for the Federal Medico-Biological Agency of Russia, Russia, Tel: Phone +79166083431; E-mail: gtarasova@yandex.ru