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

Dr. August Wolff GmbH & Co. KG Arzneimittel154 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

154

Conditions

Sore-throat Upper Respiratory Infection

Interventions

Verum (WO 6607)DEVICE

Mouth and throat rinse and gargle solution

Placebo (WO 6608)DEVICE

Mouth and throat rinse and gargle solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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).

Locations (1)

Central City Clinical Hospital of Ivano-Frankivsk

Ivano-Frankivsk, Ukraine

Outcomes

Primary Outcomes

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)

Time frame: Day 1 vs Day 4

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

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Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Day 1, Day 2, Day 3, Day 7±1, Day 14±1