This study aims to evaluete of tthe efficacy and safety of using different doses of the drug Grammidin with anesthetic, a metered dose topical spray, in the treatment of acute infectious and inflammatory pharyngeal diseases.
Male or female patients aged 18 to 75 years inclusive.
Unpleasant sensations/discomfort in the throat - symptoms of pharyngeal paresthesia (scratchy throat, dryness or sore sensation ("foreign body" sensation));
Painful sensations in the throat, including sore throat at rest, throat burning, or pain upon swallowing saliva;
Severity of the symptom "sore throat" from 55 mm to 80 mm on the Visual Analog Scale (VAS).
Erroneous inclusion of a patient in the study (not meeting inclusion/exclusion criteria at the time of randomization).
Ineffectiveness of therapy. Therapy will be considered ineffective if there is no clinical improvement by Visit 2 (Day 3-4 of therapy) - persistence or worsening of the symptom "sore throat" and catarrhal phenomena compared to baseline data. If excluded, the patient will be assigned alternative treatment at the discretion of the investigator.
Patient non-compliance (a patient is considered compliant if the number of applications of the study drug/comparison drug is not less than 17 and not more than 25).
Smoking more than 10 cigarettes per day.
Parallel
Grammidin with anesthetic
DrugGrammidin with anesthetic, a metered dose topical spray
Septolete Total
DrugSeptolete Total, lozenges 3 mg + 1 mg
Combined primary efficacy endpoint: VAS + TPA
The primary efficacy endpoint will consist of two components: Change in sore throat severity as measured by the Visual Analog Scale (VAS) one hour after the first administration of the drug (STPID1h). In accordance to VAS, 0 mm - no pain, while 100 mm is the worst pain ever. Change in the severity of clinical symptoms according to the Tonsillopharyngitis Assessment Scale (TPA) at Visit 3 (or at the time of complete recovery and treatment completion if it occurs earlier). In accordance to TPA, each symptom is assessed from 0 points (absence or weak symptom) to 2 points (strong symptom).
Change in sore throat severity, 30 min
Change in sore throat severity as measured by the Visual Analog Scale (VAS) 30 minutes after the first administration of the drug. In accordance to VAS, 0 mm - no pain, while 100 mm is the worst pain ever.
Change in sore throat severity, Visits 2 and 3
Change in sore throat severity as measured by the VAS at Visits 2 and 3. In accordance to VAS, 0 mm - no pain, while 100 mm is the worst pain ever.
Change in the severity of clinical symptom
Change in the severity of clinical symptoms according to the Tonsillopharyngitis Assessment Scale at Visit 2. In accordance to TPA, each symptom is assessed from 0 points (absence or weak symptom) to 2 points (strong symptom).
Proportion of patients with no erythema and edema of the pharyngeal mucosa
Proportion of patients with no erythema and edema of the pharyngeal mucosa according to the Erythema and Edema subscale of the Tonsillopharyngitis Clinical Symptom Severity Scale at Visits 2 and 3.
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