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

Not Applicable

Completed

• Conditions: Sore-throat; Upper Respiratory Infection
• Interventions: Device: Verum (WO 6607); Device: Placebo (WO 6608)

• Registration Number: NCT06244615
• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-06
• Study Start: 2024-03-25
• Primary Completion: 2025-02-17
• Study Completion: 2025-02-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum mouth and throat rinse	Verum (WO 6607)	Formulation containing WO 6607 for oral administration (rinse and gargle).
Placebo mouth and throat rinse	Placebo (WO 6608)	Formulation containing WO 6608 for oral administration (rinse and gargle).

Primary Outcome Measures

Name	Time	Method
Change in total severity score of throat irritation for subjective and objective symptoms during the clinical investigation (comparison between verum and placebo)	Day 1 vs Day 4	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)

Secondary Outcome Measures

Name	Time	Method
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	Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1	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)
Global judgement of efficacy by the investigator	Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14	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
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the recovery time	Day 1 vs. Day 7 and Day 1 vs. Day 14	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
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the presence of Metapneumovirus and Bocavirus	Day 1 vs. Day 4	Comparison between Verum and Placebo: Combined nasal and oropharyngeal swab sampling for PCR detection of viruses without CT values reported for Metapneumovirus and Bocavirus
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo by analysing the detection of viruses	Day 1 vs. Day 2,Day 1 vs. Day 4, Day 1 vs. Day 7 and Day 1 vs. Day 14	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)
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the proportion of rebound after treatment phase	Day 1 vs. Day 7 and Day 1 vs. Day 14	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
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	Day 1 vs. Day 7 and Day 1 vs. Day 14	Comparison between Verum and Placebo: Number of patients with the need for further medical intervention or treatments such as rescue therapy or pain medication
Global judgement of efficacy by the patient	Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14	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
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the objective symptoms of mucous swelling and oropharyngeal color (erythema)	Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1	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)
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)	Day 1 vs. Day 7 and Day 1 vs. Day 14	Comparison between Verum and Placebo: Number of patients in percent (%) having an expansion of the symptoms (e.g., subsequent bronchitis)
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)	Day 1, Day 2, Day 3, Day 7±1, Day 14±1	The safety will be assessed through adverse events

Trial Locations

Locations (1)

Central City Clinical Hospital of Ivano-Frankivsk; 🇺🇦 Ivano-Frankivs'k, Ukraine