Clinical Efficacy and Safety of Pentanedioic Acid Imidazolyl Ethanamide in Patients Aged 3 to 6 years with Influenza and other Acute Respiratory Viral Infections Based on the Results of Double-Blind Randomized Placebo-Controlled Multicenter Study

Abstract

Study Goals. Assessment of the efficacy and safety of the Pentanedioic Acid Imidazolyl Ethanamide (IPA) in the treatment of influenza and other acute respiratory viral infections (ARVI) in children aged 3–6 years. Children Characteristics and Study Methods. The randomized double-blind placebo-controlled multicenter clinical study involving 190 patients aged 3–6 years was carried out as follows: 95 patients received IPA at 30 mg/day dose once for 5 days and 95 patients – placebo using the same pattern. The therapy efficacy was assessed by the body temperature, dynamics of the individual symptoms of the disease as per the Severity Scale for the patients with influenza and other acute respiratory viral infections (Scale) and the incidence rate of complications of the acute respiratory viral infections. The primary endpoint is the period of the score reduction on the Scale to 2 points, providing that there is not more than 1 score on the individual subscales with the body temperature normalization from the start of treatment. The safety analysis was carried out using the assessment of the nature and incidence rate of the adverse events. Results. The IPA use at 30 mg/day dose significantly promotes the achievement of goals for the primary endpoint – the average value in the IPA group is 91.79 h (95% confidence interval – CI from 87.45 to 96.13), in the placebo group – 100.12 h (95% CI from 96.73 to 103.51). In the IPA group, the body temperature returned to normal by 18.56 h faster in average compared with the placebo. The regression of the catarrhal and intoxication symptoms was significantly promoted with the IPA use as follows: by the 3rd day of the therapy, the average score on the Scale was 5.22 points for IPA, and it was statistically significantly lower than that in the placebo group – 6.21 points. The comparative analysis of the incidence rate of adverse events did not reveal the statistically significant differences between IPA and placebo. None of the adverse events recorded was clinically significant, and none caused the cancellation or change in the dosage of the study drug. Conclusions. IPA broad-spectrum antiviral drug at 30 mg/day dose has demonstrated the high efficacy in the treatment of the acute respiratory viral infections of various etiologies in children aged 3–6 years. The IPA use compared with the placebo causes the significant reduction of the fever period, accelerates the relief of the intoxication and catarrhal symptoms, and decreases the recovery time. The IPA is characterized by high tolerability and high safety, which allows to recommend the drug for the treatment of influenza and ARVI (acute respiratory viral infections) in children from 3 years of age.