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

Primary Purpose

Sore Throat

Status
Completed
Phase
Phase 3
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
Lysobact Complete Sprey
Tantum Verde® Spray
Pharyngal® Oromucosal Spray
Placebo
Sponsored by
Bosnalijek D.D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sore Throat focused on measuring acute sore throat, lysobact

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Lysobact Complete Sprey

Tantum Verde® Spray

Pharyngal® Oromucosal Spray

Placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators
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 Outcome Measures

Full Information

First Posted
July 11, 2017
Last Updated
March 15, 2021
Sponsor
Bosnalijek D.D
Collaborators
MonitorCRO
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1. Study Identification

Unique Protocol Identification Number
NCT03282045
Brief Title
Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
May 24, 2018 (Actual)
Study Completion Date
May 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bosnalijek D.D
Collaborators
MonitorCRO

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat
Keywords
acute sore throat, lysobact

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
346 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lysobact Complete Sprey
Arm Type
Experimental
Arm Description
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.
Arm Title
Tantum Verde® Spray
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pharyngal® Oromucosal Spray
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lysobact Complete Sprey
Intervention Description
Inhaling spray
Intervention Type
Drug
Intervention Name(s)
Tantum Verde® Spray
Intervention Description
Inhaling spray
Intervention Type
Drug
Intervention Name(s)
Pharyngal® Oromucosal Spray
Intervention Description
Inhaling spray
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inhaling spray
Primary Outcome Measure Information:
Title
to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators
Description
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).
Time Frame
Day 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
OZGUN ENVER, MD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinical Center of the Republic of Srpska, ENT Clinic, Banja Luka, Bosnia and Herzegovina
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina

12. IPD Sharing Statement

Learn more about this trial

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

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