Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat

Study Overview
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Brief Summary
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The purpose of this study was to evaluate no less therapeutic efficacy and safety of the Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC Valeant, Russia) in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat.

Official Title
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Prospective, Multicenter, Open, Randomized, Parallel, Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray [Menthol], 0,5 mg + 2 mg / 1 ml (Sandoz d.d., Slovenia), and ANTI-ANGIN® FORMULA, Topical Metered Spray, 0,12 mg + 0,24 mg / Dose (OOO Valeant, Russia) in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat

Conditions
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Sore Throat

Intervention / Treatment
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* Drug: Angal S, topical spray [Menthol]
* Drug: ANTI-ANGIN® FORMULA, topical metered spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily signed informed consent for participation in this clinical study; 18 to 45 years old inclusive, male and female; Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat; Onset of first symptoms of the uncomplicated acute infectious and inflammatory diseases of the pharynx (pharyngitis and/or tonsillitis) less than 48 hours prior to inclusion into the study; Baseline TSS score (Tonsillopharyngitis Severity Score) ≥ 5 (total score); Body temperature 37,5 C (axillary). Exclusion Criteria: Use of analgesics within <12 hours prior to the study start or/and inability to cancel them during the study; Use of antibiotics within <48 hours prior to the study start or/and inability to cancel them during the study; Use of local therapy (sprays, rinses, lozenges) to pharynx within <12 hours before study start or/and inability to cancel them, besides study medications; Use systemic or inhaled corticosteroids within ≤1 months prior to the study start and planned therapy of them during the study (besides skin means); Presence of symptoms of primary bacterial pharyngitis or secondary bacterial infection (including fever over 37,5 ° C, the presence of purulent raids in the throat, severe intoxication, leukocytosis, neutrophilia, shift leukocyte left (increasing the percentage of neutrophils sticks appearance younger forms of neutrophils), increased ESR 30 mm/hr).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Angal S (Arm A)<br>Patients received Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution | Drug: Angal S, topical spray [Menthol]<br>* 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution<br>|
| Active Comparator: ANTI-ANGIN® FORMULA (Arm B)<br>Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC Valeant, Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution | Drug: ANTI-ANGIN® FORMULA, topical metered spray<br>* 0,12 mg + 0,24 mg (LLC Valeant, Russia) administered as one to two consecutive presses on the actuator button, up to 6 times per day, , for a maximum 5 days or until full illness resolution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15. | 4 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a ≥50% TSS Total Score Reduction | Percentage of participants with a ≥50% TSS Total Score Reduction according to the TSS questionnaire completed by the Investigator as compared to the baseline. The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15. | 4 days | 
| Change From Baseline in TSS Total Score | Change from baseline in TSS total score completed by the Investigator as compared to the baseline. The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15. | 4 days | 
| Number of Participants Who Fully Recovered | Number of Participants who Fully Recovered by Day 4 in Group A and by Day 5 in Group B (the outcome of a disease according to the objective evaluation by the Investigator, the total score according to the TSS questionnaire ≤ 2) | Group A: 4 days Group B: 5 days | 
| Change in the Sore Throat Intensity by 100 mm VAS | Change in the sore throat intensity by 100 mm VAS (visual analogue scale filled in by the patient) at the start and after 3 days of therapy. The VAS is a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of no pain at all and worst pain imaginable. The VAS ranges from 0 to 100. A decrease from baseline in the VAS score to reflect pain intensity indicates a decrease in pain intensity. | 4 days | 
| Period of Time Required for Disappearance of the Disease Symptoms | A period of time required for disappearance of the disease symptoms, determined according to the patient's diary (subjective patient's evaluation), but no more than 5 days during the trial-for patients who have achieved the corresponding outcome. | 5 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angal S, ANTI-ANGIN FORMULA, Sore Throat, no less therapeutic efficacy