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)

Dr. August Wolff GmbH & Co. KG Arzneimittel1 site in 1 country154 target enrollmentMarch 25, 2024

ConditionsSore-throat Upper Respiratory Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sore-throat
Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Enrollment: 154
Locations: 1
Primary Endpoint: Change in total severity score of throat irritation for subjective and objective symptoms during the clinical investigation (comparison between verum and placebo)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 25, 2024

End Date

February 17, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Responsible Party

Sponsor

Eligibility Criteria

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).

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)

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: 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 Outcomes

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)
Global judgement of efficacy by the investigator(Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14)
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)
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)
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)
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)
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)
Global judgement of efficacy by the patient(Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14)
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)
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)
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)