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

NCT03282045 | Completed Phase 3

• 1 other identifier: BOS_CS_01
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

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).

Conditions

Sore Throat

Keywords

acute sore throat; lysobact

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 6

Study Arms (4)

Lysobact Complete Sprey

EXPERIMENTAL

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.

Drug: Lysobact Complete Sprey

Tantum Verde® Spray

ACTIVE COMPARATOR

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.

Drug: Tantum Verde® Spray

Pharyngal® Oromucosal Spray

ACTIVE COMPARATOR

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.

Drug: Pharyngal® Oromucosal Spray

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Lysobact Complete Sprey DRUG

Inhaling spray

Lysobact Complete Sprey

Tantum Verde® Spray DRUG

Inhaling spray

Tantum Verde® Spray

Pharyngal® Oromucosal Spray DRUG

Inhaling spray

Pharyngal® Oromucosal Spray

Placebo DRUG

Inhaling spray

Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bosnalijek D.D: lead
• MonitorCRO: collaborator

Study Sites (1)

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

Banja Luka, 78000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• OZGUN ENVER, MD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: September 13, 2017
• Study Start: October 1, 2016
• Primary Completion: May 24, 2018
• Study Completion: May 24, 2018
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

BO (1)