Clinical trial NCT06244615: Clinical Trial of a Mouth and Throat Rinse for the Treatment of Acute Sore Throat
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sore-throat
Upper Respiratory Infection
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
Collaborators: name: Pharmaxi LLC
name: Labor Dr. Fenner und Kollegen
First posted: 2024-02-06
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change in total severity score of throat irritation for subjective and objective symptoms during the clinical investigation (comparison between verum and placebo)
timeFrame: Day 1 vs Day 4
Secondary outcomes:
measure: Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo by analysing the detection of viruses
timeFrame: Day 1 vs. Day 2,Day 1 vs. Day 4, Day 1 vs. Day 7 and Day 1 vs. Day 14
measure: 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
timeFrame: Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1
measure: Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the objective symptoms of mucous swelling and oropharyngeal color (erythema)
timeFrame: Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1
measure: Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the recovery time
timeFrame: Day 1 vs. Day 7 and Day 1 vs. Day 14
measure: Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the proportion of rebound after treatment phase
timeFrame: Day 1 vs. Day 7 and Day 1 vs. Day 14
measure: 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)
timeFrame: Day 1 vs. Day 7 and Day 1 vs. Day 14
measure: 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
timeFrame: Day 1 vs. Day 7 and Day 1 vs. Day 14
measure: Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the presence of Metapneumovirus and Bocavirus
timeFrame: Day 1 vs. Day 4
measure: Global judgement of efficacy by the patient
timeFrame: Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14
measure: Global judgement of efficacy by the investigator
timeFrame: Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14
measure: 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)
timeFrame: Day 1, Day 2, Day 3, Day 7±1, Day 14±1
Other outcomes:
Locations:
city: Ivano-Frankivs'k
country: Ukraine
facility: Central City Clinical Hospital of Ivano-Frankivsk
Study officials:
affiliation: Central City Clinical Hospital of Ivano-Frankivsk
name: Roman Fishchuk, MD
role: PRINCIPAL_INVESTIGATOR
References: