Study of the effectiveness and safety of a combination of a hypertonic solution and high molecular weight hyaluronic acid (Ingasalin® 3%) in the form of inhalation in the treatment of acute bronchitis against the background of acute respiratory infections in children 3-7 years old

Introduction. Cough is the most common manifestation of respiratory infections affecting the upper and lower airways, indicating impaired mucociliary clearance. Mucolytic agents are often used to normalize the patient's condition and improve mucus clearance. To normalize the patient's condition and improve mucus clearance, mucolytic agents are often used. Considering the mucolytic action of hypertonic solutions, we conducted a comparative clinical study to evaluate the efficacy and safety of a combination of 3% hypertonic saline solution and high molecular weight hyaluronic acid 0.01% (Ingasalin® 3%) in the treatment of acute bronchitis during acute respiratory infections. Objective: To evaluate the efficacy and safety of a combination of 3% hypertonic saline solution and high molecular weight hyaluronic acid 0.01% (Ingasalin® 3%) in the treatment of acute bronchitis during acute respiratory infections in children aged 3 to 7 years. Materials and Methods: The study involved 120 patients aged 3 to 7 years with acute bronchitis during acute respiratory infections (ARI). All patients were randomly assigned to two groups using simple randomization: Group 1 consisted of 60 patients who received a combination of 3% hypertonic sterile saline solution and 0.01% hyaluronic acid (Ingasalin® ) (1 ampule of 5 ml solution administered twice a day for 5 days) via nebulizer. Group 2 consisted of 60 patients who received Ambroxol solution for inhalation at a dose appropriate for the patient's age via nebulizer. Objective signs of the disease (cough frequency, productivity (dry/wet) cough, auscultatory lung findings (presence of rales, character of rales)) were assessed dynamically on days 1, 3, 5, and 7 of treatment using a scoring system for symptoms and noting adverse events (if they occurred). Results. By the 3rd day of treatment, the majority of children (85%) in the Ingasalin® group showed a more pronounced regression in both daytime and nighttime cough. In the Ingasalin® group, daytime cough decreased from 3.9±0.5 to 1.8±0.03 points and nighttime cough decreased from 2.8±0.4 to 0.9±0.04 points compared to the comparison group (Ambroxol): reduction of daytime cough from 4.1±0.4 to 2.4±0.02 points and nighttime cough from 2.67±0.2 to 1.6±0.05 points (p<0.05). By the 5th day of treatment, a significant reduction in the severity of daytime and nighttime cough by less than 1 point was noted in children in both groups, with no statistically significant differences between the groups. According to patient diaries, by the 7th day of treatment, cough was absent in 74% of children. Clinical assessment of treatment showed that by the 7th day of observation, recovery was observed in 85% of children in the Ingasalin® group, while in the comparison group, it was observed in 75%. Complete absence of cough was considered the criterion for recovery. Adverse events during treatment in both groups were comparable. Conclusions: The conducted study demonstrated that a 3% hypertonic solution in combination with high molecular weight hyaluronic acid (Ingasalin® 3%) is an effective solution in the treatment of acute bronchitis accompanied by cough in children with respiratory tract infections (RTIs), and even surpasses the synthetic mucoregulatory drug (ambroxol) in terms of effectiveness and onset of action speed.