Clinical trial NCT04941976: Benzydamine in Sore Throat Pain Relief (BePaiR Study)
Official title: Phase IV Study Comparing the Efficacy and Safety of Benzydamine Hydrochloride 0,3% Oromucosal Spray and Benzydamine Hydrochloride 3 mg Lozenges in Patients With Acute Sore Throat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Sore Throat
Keywords: oromucosal spray
lozenges
Benzydamine hydrochloride 0.3%
Benzidamine hydrochloride 3 mg
acute sore throat
Lead sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Sponsor class: INDUSTRY
Collaborators: name: Zak-Pharma Dienstleistung Ges.m.b.H.
First posted: 2021-06-28
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomised, active-controlled, open label, parallel-group, international study.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to generate new clinical data about the speed of relief provided by a single application of Benzydamine hydrochloride 0,3% oromucosal spray vs Benzydamine hydrochloride 3 mg lozenges mint flavour.

Detailed description: The efficacy and safety of benzydamine local-applied, in the treatment of various throat inflammatory and painful conditions, had been widely demonstrated.

The aim of this study is to generate new clinical data about the speed of relief provided by a single application of Benzydamine hydrochloride 0,3% oromucosal spray or Benzydamine hydrochloride 3 mg lozenges mint flavour.

The study will be conducted at 15 sites located among Poland, Hungary and Russia (5 sites for each country).

356 patients affected by acute sore throat will be enrolled in out-patient clinics or out-patient departments of city hospitals.

Eligibility criteria: 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 URTI questionnaire;
  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 a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the Visit 2, using an appropriate birth control 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 Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered:

  * Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
* Patients legally capable of giving their consent to participate in the study (including personal data processing) and available to sign and date the written informed 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 (chronic antibiotic use, such as for acne, is acceptable); any sustained release analgesic within 24 hours of administration of study medication; any medications for cold and flu (i.e., decongestants, antihistamines, expectorants, antitussives), immediate release analgesic or antipyretic within 4 hours of administration of study medication;
* Use of any lozenge, mouthwash, spray or menthol-containing products within 2 hours of administration 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.

Primary outcomes:
measure: Percentage of responders at 2 min
timeFrame: 2 minutes
Secondary outcomes:
measure: Percentage of responders at 1 min
timeFrame: 1 minute
measure: Percentage of patients recording a meaningful sore throat relief
timeFrame: 5,10,15,30,60 and 120 minutes
measure: Change in Sore Throat Relief Rating Scale.
timeFrame: 1, 2, 5,10,15,30,60,120,240 minutes
measure: Change in sore throat pain intensity.
timeFrame: Baseline, 7 day
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Háziorvosi Rendelő
city: Budapest
country: Hungary
facility: Háziorvosi Rendelő
city: Pilisvörösvár
country: Hungary
facility: Háziorvosi Rendelő
city: Tárnok
country: Hungary
facility: Háziorvosi Rendelő
city: Érd
country: Hungary
facility: Háziorvosi Rendelő
city: Krakow
country: Poland
facility: NZOZ Centrum Zdrowia i Profilaktyki Dabie Filia
city: Krakow
country: Poland
facility: NZOZ Centrum Zdrowia i Profilaktyki Dabie Krakow
city: Lodz
country: Poland
facility: ValeoMedical
city: Warszawa
country: Poland
facility: Zdrowa Rodzina Przychodnia Lekarska
city: Warszawa
country: Poland
facility: Przchodnia Orlik
city: Saint Petersburg
country: Russian Federation
facility: Scientific research center Eco-Safety, LLC
city: Saint Petersburg
country: Russian Federation
facility: Scientific research center Eco-Safety, LLC
city: Saint Petersburg
country: Russian Federation
facility: Private Healthcare Institution "Clinical Hospital "RZD-Medicine" St.Petersburg"
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Healthcare Institution "City outpatient clinic #106"
city: Saint Petersburg
country: Russian Federation
facility: Hospital "OrKli" LLC
city: Saint Petersburg
country: Russian Federation
facility: "Astarta" LLC
city: Saint Petersburg
country: Russian Federation
facility: "Meili" LLC
Study officials:
References: