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

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

Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone

BACKGROUND: The safe and appropriate use of long-acting beta-agonists (LABAs) for the treatment of asthma has been widely debated. In two large clinical trials, investigators found a potential risk of serious asthma-related events associated with LABAs. This study was designed to evaluate the risk of administering the LABA salmeterol in combination with an inhaled glucocorticoid, fluticasone propionate. METHODS: In this multicenter, randomized, double-blind trial, adolescent and adult patients (age, ≥12 years) with persistent asthma were assigned to receive either fluticasone with salmeterol or fluticasone alone for 26 weeks. All the patients had a history of a severe asthma exacerbation in the year before randomization but not during the previous month. Patients were excluded from the trial if they had a history of life-threatening or unstable asthma. The primary safety end point was the first serious asthma-related event (death, endotracheal intubation, or hospitalization). Noninferiority of fluticasone-salmeterol to fluticasone alone was defined as an upper boundary of the 95% confidence interval for the risk of the primary safety end point of less than 2.0. The efficacy end point was the first severe asthma exacerbation. RESULTS: Of 11,679 patients who were enrolled, 67 had 74 serious asthma-related events, with 36 events in 34 patients in the fluticasone-salmeterol group and 38 events in 33 patients in the fluticasone-only group. The hazard ratio for a serious asthma-related event in the fluticasone-salmeterol group was 1.03 (95% confidence interval [CI], 0.64 to 1.66), and noninferiority was achieved (P=0.003). There were no asthma-related deaths; 2 patients in the fluticasone-only group underwent asthma-related intubation. The risk of a severe asthma exacerbation was 21% lower in the fluticasone-salmeterol group than in the fluticasone-only group (hazard ratio, 0.79; 95% CI, 0.70 to 0.89), with at least one severe asthma exacerbation occurring in 480 of 5834 patients (8%) in the fluticasone-salmeterol group, as compared with 597 of 5845 patients (10%) in the fluticasone-only group (P<0.001). CONCLUSIONS: Patients who received salmeterol in a fixed-dose combination with fluticasone did not have a significantly higher risk of serious asthma-related events than did those who received fluticasone alone. Patients receiving fluticasone-salmeterol had fewer severe asthma exacerbations than did those in the fluticasone-only group