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Acute Sore ThroatPhase 4BePaiRNCT04941976

Benzydamine in Sore Throat Pain Relief (BePaiR Study)

A Phase 4 study testing 0.3% benzydamine hydrochloride spray oromucosal solution and Single 3 mg lozenge of benzydamine hydrochloride (mint flavour) in people with Acute Sore Throat, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 17 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Sore Throat
What is being tested?
0.3% benzydamine hydrochloride spray oromucosal solution and Single 3 mg lozenge of benzydamine hydrochloride (mint flavour)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
356 participants
Where
17 sitesin 3 countries
Study dates
13 Aug 2020to 30 Jun 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

17 sites in 3 countries.

17 sites in 3 countries

Russia7 sites

  • Scientific research center Eco-Safety, LLC

    Saint Petersburg, 191119

  • Scientific research center Eco-Safety, LLC

    Saint Petersburg, 195009

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

    Saint Petersburg, 195271

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

    Saint Petersburg, 197706

  • Hospital "OrKli" LLC

    Saint Petersburg, 199178

  • "Astarta" LLC

    Saint Petersburg, 199226

  • "Meili" LLC

    Saint Petersburg, 199405

Other trials in Russia

Hungary5 sites

  • Háziorvosi Rendelő

    Budapest, H-1082

  • Háziorvosi Rendelő

    Budapest, H-1138

  • Háziorvosi Rendelő

    Érd, H-2030

  • Háziorvosi Rendelő

    Pilisvörösvár, H-2085

  • Háziorvosi Rendelő

    Tárnok, H-2461

Other trials in Hungary

Poland5 sites

  • NZOZ Centrum Zdrowia i Profilaktyki Dabie Filia

    Krakow, 31-422

  • NZOZ Centrum Zdrowia i Profilaktyki Dabie Krakow

    Krakow, 31-567

  • ValeoMedical

    Lodz, 94-004

  • Zdrowa Rodzina Przychodnia Lekarska

    Warsaw, 02-785

  • Przchodnia Orlik

    Warsaw, 04-041

Other trials in Poland

About this 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

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.

Read the 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.

Being tested
0.3% benzydamine hydrochloride spray oromucosal solution, Single 3 mg lozenge of benzydamine hydrochloride (mint flavour)
Keywords
oromucosal spray, lozenges, Benzydamine hydrochloride 0.3%, Benzidamine hydrochloride 3 mg, acute sore throat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.3% benzydamine hydrochloride spray oromucosal solutionDrug

    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)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.

Study groups in NCT04941976
Study groupRoleWhat they receive
0.3% benzydamine hydrochloride spray oromucosal solutionExperimentalA single application of 0.3% benzydamine hydrochloride spray oromucosal solution, corresponding to 2.04 mg of benzydamine (4 nebulizations)
Receives: Drug: 0.3% benzydamine hydrochloride spray oromucosal solution
3 mg lozenge of benzydamine hydrochloride (mint flavour), corresponding to 2.68 mg of benzydamineActive comparatorA single 3 mg lozenge of benzydamine hydrochloride (mint flavour), corresponding to 2.68 mg of benzydamine.
Receives: Drug: Single 3 mg lozenge of benzydamine hydrochloride (mint flavour)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: 2 minutes

Secondary outcomes (4)

  1. 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".

    Measured: 1 minute

  2. 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.

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

  3. 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"

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

  4. 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".

    Measured: Baseline, 7 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2021
  2. Study start13 Aug 2020
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, randomised, active-controlled, open label, parallel-group, international study.
Masking
None (open label)
Enrolment
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04941976
Sponsor's protocol ID
030(Z)WO19176
Other IDs
2019-003257-29, 2019
Acronym
BePaiR
Status last verified
Jul 2021
First submitted
23 Jun 2021
Last updated
22 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 0.3% benzydamine hydrochloride spray oromucosal solution and Single 3 mg lozenge of benzydamine hydrochloride (mint flavour) in people with Acute Sore Throat, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 17 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Russia, Hungary, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of responders at 2 min (time frame: 2 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04941976.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.

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