Abstract
Aim. To evaluate effectiveness and safety of combination drug containing ambroxol, guaifenesin and levosalbutamol (Ascoril LS), oral solution, in comparison with monocomponent drugs in the treatment of productive cough in adult patients with acute respiratory viral infection (ARVI) and acute bronchitis.
Materials and methods. Open randomized study included patients with clinical symptoms of ARVI and acute bronchitis, having productive cough with difficulty in sputum discharge. 160 patients were randomized into 4 groups that received the study drug or comparison drugs (ambroxol, acetylcysteine, Rengalin) 3 times a day for 20 days. After 5, 10, 15 and 20 days of treatment, the doctor assessed subjective complaints and effectiveness of therapy. The primary endpoint was the proportion of patients with high and very high efficacy, recovery from work, and clinically significant cardiovascular events.
Results. Satisfaction with clinical effect of therapy with Ascoril LS was noted by 96% of patients, tolerability and ease of administration by 99%. 97% of patients are satisfied with price/quality ratio. The overall percentage of satisfaction with treatment Ascoril LS was 99%. Tolerability of therapy was assessed by all patients as good, without the development of significant adverse events. During therapy for productive cough, a significant decrease in cough was noted in Ascoril LS group already on the 5th day of therapy (57%) and subsequently at all follow-up visits. Restoration of working capacity of patients in Ascoril LS group due to complete regression of productive cough was established in 50% of patients on the 5th day of treatment. On days 10 and 15, 75% and 90% of patients, respectively, were able to begin work due to complete relief of cough, which is significantly more compared to other treatment groups. It is important that in all cases Ascoril LS was prescribed at the very beginning of the disease, which made it possible to achieve the described results
Conclusion. The effectiveness of a new combination drug containing ambroxol, guaifenesin and levosalbutamol for the treatment of productive cough in adult patients with ARVI and acute bronchitis exceeds the effectiveness of monocomponent therapy with comparator drugs. The safety profiles of the study drug and comparison drugs were comparable, including in patients with cardiovascular risk.
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