Benzydamine in Sore Throat Pain Relief (BePaiR Study)

Acute Sore Throat Clinical Trial

— BePaiR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941976
• Other study ID #: 030(Z)WO19176
• Secondary ID: 2019-003257-29
• Status: Completed
• Phase: Phase 4
• Start date: August 13, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Sore Throat
• Pharyngitis

Intervention

Drug:
• 0.3% benzydamine hydrochloride spray oromucosal solution
Single application of 0.3% benzydamine hydrochloride spray oromucosal solution. Drug applications will be performed at the investigational site, on the morning of Visit 0. In case of persistent sore throat patients will continue the assigned treatment at home, according to the local SmPC and up to one week, until the symptoms' resolution.
• Single 3 mg lozenge of benzydamine hydrochloride (mint flavour)
Single 3 mg lozenge of benzydamine hydrochloride (mint flavour). Drug applications will be performed at the investigational site, on the morning of Visit 0. In case of persistent sore throat patients will continue the assigned treatment at home, according to the local SmPC and up to one week, until the symptoms' resolution.

Locations

Country	Name	City	State
Hungary	Háziorvosi Rendelo	Budapest
Hungary	Háziorvosi Rendelo	Budapest
Hungary	Háziorvosi Rendelo	Érd
Hungary	Háziorvosi Rendelo	Pilisvörösvár
Hungary	Háziorvosi Rendelo	Tárnok
Poland	NZOZ Centrum Zdrowia i Profilaktyki Dabie Filia	Krakow
Poland	NZOZ Centrum Zdrowia i Profilaktyki Dabie Krakow	Krakow
Poland	ValeoMedical	Lodz
Poland	Przchodnia Orlik	Warszawa
Poland	Zdrowa Rodzina Przychodnia Lekarska	Warszawa
Russian Federation	"Astarta" LLC	Saint Petersburg
Russian Federation	"Meili" LLC	Saint Petersburg
Russian Federation	Hospital "OrKli" LLC	Saint Petersburg
Russian Federation	Private Healthcare Institution "Clinical Hospital "RZD-Medicine" St.Petersburg"	Saint Petersburg
Russian Federation	Saint-Petersburg State Budgetary Healthcare Institution "City outpatient clinic #106"	Saint Petersburg
Russian Federation	Scientific research center Eco-Safety, LLC	Saint Petersburg
Russian Federation	Scientific research center Eco-Safety, LLC	Saint Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
Aziende Chimiche Riunite Angelini Francesco S.p.A	Zak-Pharma Dienstleistung Ges.m.b.H.

Countries where clinical trial is conducted

Hungary,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of responders at 2 min	Percentage of responders defined as patients reported at least a "slight relief" using Sore Throat Relief Rating Scale at 2 minutes after the first application of benzydamine hydrochloride 0.3% spray or benzydamine hydrochloride 3mg lozenges.; A score =1 in Sore Throat Relief Rating Scal is considered as the first perceived pain relief or "slight relief".	2 minutes
Secondary	Percentage of responders at 1 min	Percentage of responders defined as patients reported at least a "slight relief" using Sore Throat Relief Rating Scale at 1 minute after the first application of benzydamine hydrochloride 0.3% spray or benzydamine hydrochloride 3mg lozenges.; A score =1 in Sore Throat Relief Rating Scal is considered as the first perceived pain relief or "slight relief".	1 minute
Secondary	Percentage of patients recording a meaningful sore throat relief	The meaningful sore throat relief is assessed after a single dose administration.; A "meaningful sore throat relief" is considered as a score = 3 (moderate relief) in the Sore Throat Relief Rating Scale.	5,10,15,30,60 and 120 minutes
Secondary	Change in Sore Throat Relief Rating Scale.	Change from 1 minute up to 4 hours post-dose in Sore Throat Relief Rating Scale.The Sore Throat Relief Rating Scale is a 7-point categorical scale that assesses the local analgesic effect starting from: 0= "no relief" up t 7="complete relief"	1, 2, 5,10,15,30,60,120,240 minutes
Secondary	Change in sore throat pain intensity.	Change in sore throat pain intensity from baseline up to 7 days of treatment through the Sore Throat Pain Intensity Scale assessment. The Sore Throat Pain Intensity Scale is a visual analogic scale (VAS) assessing the intensity of the Sore Throat. It consists of a continuous horizontal line of 100 mm in length with ends labelled as the extremes of pain, from 0 (left side): "no pain", to 10 (right side): "pain as bad as it could be".	Baseline, 7 day