Evaluation of Efficacy and Safety of Different Doses of Eladis® in the Therapy of Cough Against Acute Respiratory Viral Infection

Abstract

Aim. Justification of the optimal dosage regimen regarding the efficacy and safety of Eladis®, film-coated tablets, 10 mg (Valenta Pharm JSC, Russia) in comparison with placebo in patients with non-productive cough due to acute respiratory viral infection (ARVI). Material and methods. A double-blind placebo-controlled randomized multicenter study was conducted in which 141 patients with non-productive cough on the background of acute respiratory viral infection took part. The study participants were randomized into 4 groups. Patients from the first group took 1 tablet of Eladis® 2 times a day (daily dose of 20 mg); patients from the second group took 2 tablets of Eladis® 2 times a day (daily dose of 40 mg); patients from the third group took 4 tablets of Eladis® 2 times a day (daily dose of 80 mg). Patients in the fourth group received placebo tablets in quantities corresponding to the first three groups. For this purpose, 3 subgroups of 12 people were allocated within group 4. The duration of therapy was 7–14 days. The effectiveness of therapy was assessed based on monitoring the frequency of cough attacks, changes in values on the day and night cough scales, a digital rating scale (DRS), and the time to achieve clinical cure of cough and ARVI symptoms was also taken into account. The safety of the studied drug was assessed based on monitoring of vital signs, laboratory parameters, and electrocardiogram (ECG) data. The number and severity of adverse events (AEs) and serious adverse events (SAEs) were assessed. Results. Analysis of data on the primary endpoint (reduction of cough attack frequency by ;)50% by the 5th day relative to the 1st visit) showed the superiority of Eladis® over placebo at a daily dose of 80 mg (P=0.00003). At the same time, the proportion of patients who reached the primary endpoint by day 5 when receiving Eladis® at a dose of 80 mg per day was 71.43%, while in the combined placebo group it was 22.22%. Conclusion. Evaluation of various dosage regimens of Eladis® has shown that a daily dose of 80 mg is optimal for the treatment of non-productive cough in patients with ARVIs, as it provides the greatest effectiveness with a safety profile comparable to other studied doses.