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

Sandoz

Status and phase: Completed; Phase 3

Conditions: Sore Throat

Treatments: Drug: ANTI-ANGIN® FORMULA, topical metered spray; Drug: Angal S, topical spray [Menthol]

Study type: Interventional

Funder types: Industry

Identifiers

NCT03095508

TE_003_ANG_LSP

Details and patient eligibility

About

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.

Enrollment: 229 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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229 participants in 2 patient groups

Angal S (Arm A)

Experimental group

Description:

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

Treatment:

Drug: Angal S, topical spray [Menthol]

ANTI-ANGIN® FORMULA (Arm B)

Active Comparator group

Description:

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

Treatment:

Drug: ANTI-ANGIN® FORMULA, topical metered spray