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

NCT ID: NCT03282045

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-05-24

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.

Conditions

Sore Throat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lysobact Complete Sprey

Intervention Type: DRUG

Inhaling spray

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.

Group Type: ACTIVE_COMPARATOR

Tantum Verde® Spray

Intervention Type: DRUG

Inhaling spray

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.

Group Type: ACTIVE_COMPARATOR

Pharyngal® Oromucosal Spray

Intervention Type: DRUG

Inhaling spray

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inhaling spray

Interventions

Lysobact Complete Sprey

Inhaling spray

Intervention Type: DRUG

Tantum Verde® Spray

Inhaling spray

Intervention Type: DRUG

Pharyngal® Oromucosal Spray

Inhaling spray

Intervention Type: DRUG

Placebo

Inhaling spray

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MonitorCRO

INDUSTRY

Sponsor Role: collaborator

Bosnalijek D.D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

OZGUN ENVER, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

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

Banja Luka, , Bosnia and Herzegovina

Countries

Bosnia and Herzegovina

Other Identifiers

BOS_CS_01

Identifier Type: -

Identifier Source: org_study_id