Multicenter, randomized, open-label, comparative study of the effectiveness of nasal spray Aqua Maris Extra Strong as a symptomatic therapy in the technology of delayed antibiotic prescription in the treatment of acute rhinosinusitis in children aged 6–11 years.

Abstract

Antibacterial therapy in acute rhinosinusitis (ARS) is prescribed 4–9 times more often than recommended, while no >5 % of patients require such treatment. The main motive for the irrational antibiotic prescription is the presence of mucopurulent discharge and nasal congestion in combination with hyperthermia.

The study objective was to determine the efficacy of hypertonic seawater solution in the technology of delayed antibiotic prescription in patients with ARS.

Methods

In a multicenter, randomized, open-label, comparative study, 100 children were randomized. 100 children with ARS aged 6–11 years, who received Aqua Maris Extra Strong irrigation therapy in addition to standard therapy or received standard therapy, completed the study.

Evaluation criteria

decreased intensity of nasal congestion, rhinorrhea, postnasal drip, headache and facial pain, assessed by the physician using a 4-point scale at each visit compared to Visit 1, dynamics of self-scored symptoms using a 10-point visual analogue scale, frequency of antipyretic and antibiotic prescription.

Results

The use of hypertonic seawater solution in patients with ARS provides a clinically significant reduction in the severity of core or key symptoms: rhinorrhea, nasal congestion, postnasal drip and headache, assessed by the physician at V2 (p < 0.05). There are significant differences in the dynamics of these symptoms according to the patient's self-assessment from treatment Day 2 (p < 0.05).

The use of irrigation therapy with Aqua Maris Extra Strong in the technology of delayed antibiotic prescription in patients with ARS allows to reduce the prescription of antibacterial drugs. No on-treatment side effects were observed in any patient.

Conclusion

Hypertonic seawater solution Aqua Maris Extra Strong is a safe and effective medicinal product for the symptomatic treatment of acute rhinosinusitis in children aged 6–11 years. It provides a significant therapeutic effect when prescribed in addition to standard therapy and helps to reduce the need for antibiotics.