Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat

March 15, 2021 updated by: Bosnalijek D.D

A Multicenter, Single-blind, Randomized, Placebo-controlled Comparative Study on Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® Spray and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat in Common Cold

The primary objective of this multicenter, single-blind, randomized, placebo-controlled, prospective, comparative study with parallel design and 4-arms is to evaluate superiority of Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).

Study Overview

Detailed Description

This study will be conducted in approximately 3 centers in Bosnia Herzegovina and in 4 centers in Turkey.

Primary objective:

The primary objective of this study is to evaluate superiority of Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).

Secondary objective(s):

  • Safety evaluation of Lysobact Complete Spray®, Tantum Verde® Spray, Pharyngal® Oromucosal Spray, based on the frequency and nature of adverse events occurring during treatment period.
  • Extent of change in difficulty in swallowing, evaluated on the basis of Difficulty in Swallowing Scale (DSS), on Day 2, Day 4 and Day 6, as compared with baseline.
  • Extent of change in swollen throat evaluation based on Swollen Throat Scale (STS) on Day 2, Day 4 and Day 6, as compared with baseline.
  • Change in frequency of study treatment applications on Day 2, Day 4 and Day 6, as compared with baseline.

Test product: Lysobact Complete Spray® Active comparator product: Tantum Verde® Spray Active comparator product: Pharyngal® Oromucosal Spray Placebo product: Placebo

Primary endpoint:

• Primary endpoint is the change from baseline to Day 6 in mean VAS score for STPIS.

Secondary endpoint(s):

Secondary endpoints are as follows:

  • change from baseline to Day 6 in mean VAS score for DSS
  • change from baseline to Day 6 in mean VAS score for SwoTS
  • change from baseline to each visit (Day 2, Day 4, Day 6) for STPIS , DSS and SwoTS
  • percent improvement from baseline to each visit (Day 2, Day 4, Day 6) for STPIS , DSS and SwoTS
  • Incidence of adverse events and relationship to the study treatments
  • Incidence of serious adverse events and relationship to the study treatments

Statistical methods:

All patients who have received at least one dose of any study medication will be included in the safety evaluation (safety population). Patients who have completed all visits according to the protocol will be included in the efficacy population. The superiority and inferiority of Lysobact Complete Spray® will be tested in hierarchical order by the comparison of the mean change of VAS scores [Sore Throat Pain Intensity Scale (STPIS)] from baseline to Day 2, 4 and 6.

Planned treatment duration is 5 days. Safety will be followed-up until Day 6. End of study is defined as the end of the follow up period for the last patient.

Study Type

Interventional

Enrollment (Actual)

346

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Banja Luka, Bosnia and Herzegovina, 78000
        • University Clinical Center of the Republic of Srpska, ENT Clinic, Banja Luka, Bosnia and Herzegovina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with acute tonsillo-pharyngitis symptoms in common cold and by using a scale-based symptom Tonsillo-Pharyngitis Assessment (TPA) as an objective finding of pharyngeal infection, with a score of ≥5
  • Patients who will be treated only on a symptomatic treatment basis, and with a prescribed a oropharyngeal spray
  • Patients, 18 years of age and above, who provided an informed consent
  • Patients with a sore-throat of recent onset, symptoms initiated ≤48 hours
  • Patients with sore throat pain rated ≥66 mm on the Sore Throat Pain Intensity Scale (STPIS)
  • Patients with difficulty in swallowing rated ≥50 mm on Difficulty Swallowing Scale (DSS)
  • Patients with a sensation of swollen throat rated ≥33 mm on the Swollen Throat Scale (SwoTS)

Exclusion Criteria:

  • Patients who had any previous (within 4 hours prior to screening examination) throat lozenge treatment/use
  • Patients who had used any flu-preparation which contains any analgesic ingredient such as paracetamol, ibuprofen or acetylsalicylic acid (ASA) along with a decongestant
  • Patients who had analgesic use (any) 4 hours prior to the screening examination
  • Patients who are prescribed an antibiotic use before the screening visit and are entitled to use antibiotics during the course of this non-interventional study
  • Patients with a known hypersensitivity to active/inactive ingredients of medications which is prescribed for the symptomatic treatment of sore throat
  • Patients with known hypersensitiveness to egg white and other allergens
  • Patients who are pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lysobact Complete Sprey

Lysobact Complete Sprey

Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open

Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times and one press of the spray pump release 0.20 mL of the solution containing 4 mg lysozyme, 0.3 mg cetylpyridine and 0.1 mg lidocaine hydrochloride.

Inhaling spray
Active Comparator: Tantum Verde® Spray

Tantum Verde® Spray

Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open.

Dose regimen: Sprayed 4 to 8 doses, 2 to 6 times a day. One press means one dose.

Inhaling spray
Active Comparator: Pharyngal® Oromucosal Spray

Pharyngal® Oromucosal Spray

Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open.

Dose regimen: Sprayed 2 to 4 doses, repeated 6 to 10 times per day. One press of the pump (one dose) releases 0.14 ml of the solution with 0.28 mg chlorhexidine digluconate and 0.07 mg of lidocaine hydrochloride.

Inhaling spray
Placebo Comparator: Placebo

Route of administration: Sprayed directly toward the affected area with the applicator while the mouth is wide open.

Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times.

Inhaling spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators
Time Frame: Day 6
The primary objective of this study is to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
Day 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: OZGUN ENVER, MD, Istanbul University-Cerrahpasa School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

May 24, 2018

Study Completion (Actual)

May 24, 2018

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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