2.1. Study design
sore throat, Pain, sore throat pain, tonsillopharyngitis, Sore, throat, pain, DSS
SORE THROAT, TONSILLOPHARYNGITIS, UPPER RESPIRATORY TRACT INFECTION, POLAND, DIFFICULTY SWALLOWING
A multicenter, randomized, active-controlled, open label, parallel-group, international study was conducted from August 2020 to June 2021 in 12 investigational sites from different sources (general practices, hospitals, and outpatients’ facilities) located in Hungary, Poland and Russian Federation to evaluate the efficacy and the safety of benzydamine HCl 0.3% oromucosal spray and benzydamine HCl 3 mg lozenges in patients with acute ST.Adult patients (18–75 years) of both sexes, with recent onset of ST (≤3 days), at least 1 symptom of URTI in the previous 24 hours on the URTI questionnaire, a ST pain intensity score ≥ 60 mm on Sore Throat Pain Intensity Scale (STPIS) and an objective diagnosis of tonsillopharyngitis confirmed by a score ≥ 5 on the Tonsillo-Pharyngitis Assessment (TPA) were enrolled in the study. Three visits were scheduled during the study (V0, V1, and V2), and activities at each visit were performed as scheduled in Table Schedule of BePaiR study activities.DSS = difficulty swallowing scale, IMP = investigational medicinal product, PSQ = patient satisfaction questionnaire, QuaSTI = qualities of sore throat index, STPIS = sore throat pain intensity scale, STRRS = sore throat relief rating scale, SwoTS = swollen throat scale, TPA = Tonsillo-Pharyngitis assessment, URTI = upper respiratory tract infection.