Benzydamine in Sore Throat Pain Relief (BePaiR Study)

Inclusion Criteria:

• Adult male and female patients (aged 18 - 75 years, limits included) with recent onset (≤3 days) of sore throat and a diagnosis of tonsillopharyngitis confirmed by:

1. Presence of at least one symptom of URTI in the previous 24 h on the URTIquestionnaire;
2. Sore throat pain intensity score ≥ 60 mm on Sore Throat Pain Intensity Scale (STPIS);
3. A score ≥ 5 on Tonsillo-Pharingytis Assessment (TPA);

• Women of childbearing potential or with no menses for a period < 12 months must have anegative pregnancy test at Visit 0 and have to agree not to start a pregnancy from thesignature of the informed consent up to the Visit 2, using an appropriate birthcontrol method such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g.,oral, injectable, implantable), intrauterine device (IUD) or Intrauterinehormone-releasing System (IUS) in combination with male condom, bilateral tubalocclusion, vasectomised partner, sexual abstinence. The following definitions will beconsidered:
• Woman of childbearing potential (WOCBP): i.e., fertile, following menarche anduntil becoming post-menopausal, unless permanently sterile. Permanentsterilization methods include hysterectomy, bilateral salpingectomy and bilateraloophorectomy.
• Patients legally capable of giving their consent to participate in the study (including personal data processing) and available to sign and date the writteninformed consent.

Exclusion Criteria:

• Known hypersensitivity to benzydamine or its excipients;
• Phenylketonuria;
• Clinically significant abnormalities at physical examination and vital signs;
• Intolerance to acetylsalicylic acid or other NSAIDS;
• History or diagnosis of asthma;
• Any concomitant disease that compromise breathing (i.e. bronchopneumonia);
• Mouth breathing due to nasal congestion which causes throat drying;
• Severe coughing which causes throat discomfort;
• Purulent plaques on the tonsils;
• Any inhaled therapy in the previous week before the first drug administration;
• Use of antibiotics for an acute disease in the 7 days before randomisation (chronicantibiotic use, such as for acne, is acceptable); any sustained release analgesicwithin 24 hours of administration of study medication; any medications for cold andflu (i.e., decongestants, antihistamines, expectorants, antitussives), immediaterelease analgesic or antipyretic within 4 hours of administration of study medication;
• Use of any lozenge, mouthwash, spray or menthol-containing products within 2 hours ofadministration of study medication;
• Women during pregnancy or lactation period;
• Subject involved in the conduct of the study (e.g. Investigator or his/her deputy,first grade relatives, pharmacist, assistant or other personnel, etc);
• Participation to a clinical trial within 3 months prior to the inclusion in the study.