Clinical Trial of a Mouth and Throat Rinse for the Treatment of Acute Sore Throat

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of an Antiviral Mouth and Throat Rinse for the Treatment of Acute Sore Throat (Upper Respiratory Tract Infection e.g., Pharyngitis/Laryngitis)

The aim of this study is to confirm the efficacy, safety and tolerability of the Mouth and Throat Rinse in adult participants with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to placebo.

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Infection; Sore-throat
• Intervention / Treatment: Device: Verum (WO 6607); Device: Placebo (WO 6608)

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Ivano-Frankivs'k, Ukraine
    • Central City Clinical Hospital of Ivano-Frankivsk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects having clinical signs and symptoms of recent (less than 48 h) acute sore throat (upper respiratory tract infection) without signs of lower respiratory tract infection (total severity score for throat irritation baseline value ≥ 4).
• Centor Score of 0 to 3 points at screening.
• Female and male subjects with 18-75 years of age.

Exclusion Criteria:

• Known allergy to any of the components in the investigational product (Placebo or Verum) (i.e. SLS).
• Centor Score of 4 points at screening.
• Presence of exanthema.
• Presence of oral mucosal plaques e.g., soor.
• Presence of bacterial infection of the upper respiratory tract (confirmed by rapid screening test).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verum mouth and throat rinse; Formulation containing WO 6607 for oral administration (rinse and gargle).	Device: Verum (WO 6607); Mouth and throat rinse and gargle solution
Placebo Comparator: Placebo mouth and throat rinse; Formulation containing WO 6608 for oral administration (rinse and gargle).	Device: Placebo (WO 6608); Mouth and throat rinse and gargle solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total severity score of throat irritation for subjective and objective symptoms during the clinical investigation (comparison between verum and placebo)	A total severity score for throat irritation will be calculated at each visit as the sum of the subjective and objective symptoms. Each of the four criteria on a scale from 0 to 4: 1. soreness, 2. difficulty swallowing (rated by the subject), 3. mucosal swelling of the throat and 4. oropharyngeal color (erythema) (assessed by the investigator)	Day 1 vs Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo by analysing the detection of viruses	Combined nasal and oropharyngeal swab sampling for PCR detection of viruses including CT values reported for: Adenovirus, Coronaviruses including OC43, NL63, 229E and SARS-CoV-2, Influenza virus A and B, Parainfluenza virus 1-4, Rhinovirus, RSV) in adult subjects with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to Placebo (Day 1 vs. Day 2 and Day 1 vs. Day 4)	Day 1 vs. Day 2,Day 1 vs. Day 4, Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo with respect to the subjective symtoms of throat soreness and difficulty swallowing	Comparison between Verum and Placebo: Change Day 1 to Day 7±1 and Day 1 to Day 14±1 for each subjective symptom of throat soreness and difficulty swallowing (rated by the subject on a scale from 0 to 4)	Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the objective symptoms of mucous swelling and oropharyngeal color (erythema)	Comparison between Verum and Placebo: Change Day 1 to Day 7±1 and Day 1 to Day 14±1 for each objective symptom of mucous swelling, oropharyngeal color (erythema) (assessed by the investigator on a scale from 0 to 4)	Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the recovery time	Comparison between Verum and Placebo: Recovery time is defined as the time to improvement in total severity score of throat irritation value to ≤ 4, provided the score for each criterion is not > 1	Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the proportion of rebound after treatment phase	Comparison between Verum and Placebo: Number of patients (%) with a rebound after treatment phase. Rebound is defined as worsening in total severity score of throat irritation value	Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the proportion of expansion of the symptoms (e.g., subsequent bronchitis)	Comparison between Verum and Placebo: Number of patients in percent (%) having an expansion of the symptoms (e.g., subsequent bronchitis)	Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the need for further medical intervention or treatments such as rescue therapy or pain medication	Comparison between Verum and Placebo: Number of patients with the need for further medical intervention or treatments such as rescue therapy or pain medication	Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the presence of Metapneumovirus and Bocavirus	Comparison between Verum and Placebo: Combined nasal and oropharyngeal swab sampling for PCR detection of viruses without CT values reported for Metapneumovirus and Bocavirus	Day 1 vs. Day 4
Global judgement of efficacy by the patient	The global judgement of efficacy (throat soreness and difficulty swallowing) will be assessed according to the severity score: 0= none, 1= mild, 2= moderate, 3= severe, 4= very severe	Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14
Global judgement of efficacy by the investigator	The global judgement of efficacy (mucous swelling and oropharyngeal color (erythema)) will be assessed according to the following scale: 0= none, 1= mild, 2= moderate, 3= severe, 4= very severe	Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14
Evaluate the safety of the Verum Mouth and Throat Rinse in adult subjects with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis)	The safety will be assessed through adverse events	Day 1, Day 2, Day 3, Day 7±1, Day 14±1

Collaborators and Investigators

• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Collaborators: Pharmaxi LLC; Labor Dr. Fenner und Kollegen
• Investigators: Principal Investigator: Roman Fishchuk, MD, Central City Clinical Hospital of Ivano-Frankivsk

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Actual): February 17, 2025
• Study Completion (Actual): February 17, 2025

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Infections; Respiratory Tract Infections; Pharyngitis
• Other Study ID Numbers: LSMR-01/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No