Results of a multicentre double-blind placebo-controlled randomized trial of the liquid form of Anaferon for children in the treatment of acute upper respiratory tract infections

Abstract

Acute respiratory infections (ARI) are major causes of morbidity in children. Symptomatic treatment is insufficiently effective and requires additional drugs with etiotropic action. This multi-center double blind placebo-controlled randomized clinical study with superiority model design considers a liquid formulation of Anaferon for children.Methods. The study included 142 children from 1 month to 3 years 11 month 29 days old with ARI of the upper respiratory tract. They were randomized into Anaferon for children and Placebo groups (71 in each group) via interactive voice randomization system. The treatment period was 5 days, observation period – 14 days. The average duration of the symptoms and the severity of the respiratory disease were used as primary efficacy endpoints.Results. All 142 patients were randomized and included into ITT (Intention to treat) analysis. 140 patients (70 patients in each group) were included into PP-analysis. The patients in the Anaferon for children group had better results with average duration of ARI as compared to the Placebo group (87.7±31.5h vs. 103.3±19.4h; p =0.007). The authors marked efficacy of Anaferon for children in such parameters as disease severity (ITT-analysis: p=0.0004), total severity of disease symptoms (ITT-analysis: ANOVA: “Group” factor p=0.0004; “Day” factor p<0.0001), and percentage of recovered patients (Log-rank test, p=0.035). There were no discrepancies between the groups in concomitant therapy (ITT-analysis: ANOVA “Group-Day” factor p=0.88), bacterial complications frequency (p=1.0), adverse effects (Fisher criteria: p=0.5321). The authors registered 14 cases of adverse events (10 cases in Anaferon group and 4 cases in Placebo group) in 11 patients. None of the adverse events had a certain or probable relation to the studied drug.Conclusion. Anaferon for children proved their efficiency and safety in young children with ARI.