Benzydamine in Sore Throat Pain Relief (BePaiR Study)

NCT04941976 | Completed Phase 4

• 2 other identifiers: 030(Z)WO191762019-003257-29
• Study Type: interventional
• Target: 356
• Locations: 3 countries
• Sites: 17

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.

Conditions

Acute Sore Throat

Keywords

oromucosal spray; lozenges; Benzydamine hydrochloride 0.3%; Benzidamine hydrochloride 3 mg; acute sore throat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of responders at 1 min

  1 minute

• Percentage of patients recording a meaningful sore throat relief

  5,10,15,30,60 and 120 minutes

• Change in Sore Throat Relief Rating Scale.

  1, 2, 5,10,15,30,60,120,240 minutes

• Change in sore throat pain intensity.

  Baseline, 7 day

Study Arms (2)

0.3% benzydamine hydrochloride spray oromucosal solution

EXPERIMENTAL

A single application of 0.3% benzydamine hydrochloride spray oromucosal solution, corresponding to 2.04 mg of benzydamine (4 nebulizations)

Drug: 0.3% benzydamine hydrochloride spray oromucosal solution

3 mg lozenge of benzydamine hydrochloride (mint flavour), corresponding to 2.68 mg of benzydamine

ACTIVE COMPARATOR

A single 3 mg lozenge of benzydamine hydrochloride (mint flavour), corresponding to 2.68 mg of benzydamine.

Drug: Single 3 mg lozenge of benzydamine hydrochloride (mint flavour)

Interventions

0.3% benzydamine hydrochloride spray oromucosal solution DRUG

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.

0.3% benzydamine hydrochloride spray oromucosal solution

Single 3 mg lozenge of benzydamine hydrochloride (mint flavour) DRUG

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.

3 mg lozenge of benzydamine hydrochloride (mint flavour), corresponding to 2.68 mg of benzydamine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Presence of at least one symptom of URTI in the previous 24 h on the URTI questionnaire;
• Sore throat pain intensity score ≥ 60 mm on Sore Throat Pain Intensity Scale (STPIS);
• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Zak-Pharma Dienstleistung Ges.m.b.H.: collaborator

Study Sites (17)

Háziorvosi Rendelő

Budapest, H-1082, Hungary

Location

Háziorvosi Rendelő

Budapest, H-1138, Hungary

Location

Háziorvosi Rendelő

Érd, H-2030, Hungary

Location

Háziorvosi Rendelő

Pilisvörösvár, H-2085, Hungary

Location

Háziorvosi Rendelő

Tárnok, H-2461, Hungary

Location

NZOZ Centrum Zdrowia i Profilaktyki Dabie Filia

Krakow, 31-422, Poland

Location

NZOZ Centrum Zdrowia i Profilaktyki Dabie Krakow

Krakow, 31-567, Poland

Location

ValeoMedical

Lodz, 94-004, Poland

Location

Zdrowa Rodzina Przychodnia Lekarska

Warsaw, 02-785, Poland

Location

Przchodnia Orlik

Warsaw, 04-041, Poland

Location

Scientific research center Eco-Safety, LLC

Saint Petersburg, 191119, Russia

Location

Scientific research center Eco-Safety, LLC

Saint Petersburg, 195009, Russia

Location

Private Healthcare Institution "Clinical Hospital "RZD-Medicine" St.Petersburg"

Saint Petersburg, 195271, Russia

Location

Saint-Petersburg State Budgetary Healthcare Institution "City outpatient clinic #106"

Saint Petersburg, 197706, Russia

Location

Hospital "OrKli" LLC

Saint Petersburg, 199178, Russia

Location

"Astarta" LLC

Saint Petersburg, 199226, Russia

Location

"Meili" LLC

Saint Petersburg, 199405, Russia

Location

MeSH Terms

Interventions

Single Person

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, randomised, active-controlled, open label, parallel-group, international study.

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 28, 2021
• Study Start: August 13, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

PL (5); RU (7); HU (5)