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Completed

NCT Number: NCT06244615

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

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.

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Key information

Conditions

Sore-throat Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases Upper Respiratory Infection

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central City Clinical Hospital of Ivano-Frankivsk

Ivano-Frankivsk, Ukraine

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Verum (WO 6607)

Device

Mouth and throat rinse and gargle solution

Placebo (WO 6608)

Device

Mouth and throat rinse and gargle solution

Primary outcomes

  1. Change in total severity score of throat irritation for subjective and objective symptoms during the clinical investigation (comparison between verum and placebo)

    Time frame: 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:

    • soreness, 2. difficulty swallowing (rated by the subject), 3. mucosal swelling of the throat and 4. oropharyngeal color (erythema) (assessed by the investigator)

Secondary outcomes

  1. Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo by analysing the detection of viruses

    Time frame: 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)

  2. 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

    Time frame: 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)

  3. Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the objective symptoms of mucous swelling and oropharyngeal color (erythema)

    Time frame: 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)

  4. Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the recovery time

    Time frame: 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

  5. Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the proportion of rebound after treatment phase

    Time frame: 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

  6. 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)

    Time frame: 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)

  7. 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

    Time frame: 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

  8. Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the presence of Metapneumovirus and Bocavirus

    Time frame: 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

  9. Global judgement of efficacy by the patient

    Time frame: 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

  10. Global judgement of efficacy by the investigator

    Time frame: 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

  11. 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)

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

    The safety will be assessed through adverse events

Sponsors and collaborators

Lead sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Industry

Collaborators

  • Labor Dr. Fenner und Kollegen
  • Pharmaxi LLC

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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