Objective:

The aim of the study was to assess the safety and effectiveness of the GOLDisept mouth and throat spray medical device used in patients with symptoms of pharyngitis.

Material and methods:

114 patients were included in the observation. The median age was 44.5 years. Women accounted for 69.3% of the observed. The study included a qualifying visit (Visit 1) and 2 observation visits (Visit 2, 3) in the form of telephone calls with the patient or a visit to the centre. The severity of sore throat and the severity of swallowing symptoms were assessed using a numerical pain rating scale (NRS) during subsequent visits. The change in the severity of sore throat and swallowing symptoms was assessed in relation to the baseline value obtained at Visit 1. On the basis of the questionnaire at Visit 3, the use of the medical device was assessed.

Results:

Complete relief of sore throat symptoms was reported by 2 (1.8%) and 39 (34.2%) patients, respectively, at visits 2 and 3. Sore throat was rated as follows: visit 1 – severe (45.6% of observations), very severe (28.1%), or moderate (21.1%); visit 2 – moderate (50.9%), mild (26.3%), or severe (18.4%); and visit 3 – mild (52.6%), absent (34.2%), or moderate (9.6%). Swallowing discomfort was rated as follows: visit 1 – severe (by 41.2% of patients), very strong (26.3%), or moderate (19.3%); visit 2 – moderate (43.0%), mild (28.1%), or severe (21.1%); and visit 3 – mild (45.6%), absent (43.0%), or moderate (8.8%).

Conclusions:

The use of GOLDisept was safe and well tolerated. use of the product resulted in a significant reduction in the severity of sore throat and swallowing discomfort. Almost all patients experienced a reduction in pain and swallowing discomfort.