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

Upper Respiratory Infection Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06244615
• Other study ID #: LSMR-01/2022
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Contact: Clarissa Masur
• Phone: +49 521 8808 319
• Email: clarissa.masur[@]drwolffgroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infections
• Pharyngitis
• Respiratory Tract Infections
• Upper Respiratory Infection

Intervention

Device:
• Verum (WO 6607)
Mouth and throat rinse and gargle solution
• Placebo (WO 6608)
Mouth and throat rinse and gargle solution

Locations

Country	Name	City	State
Ukraine	Central City Clinical Hospital of Ivano-Frankivsk	Ivano-Frankivs'k

Sponsors (3)

Lead Sponsor	Collaborator
Dr. August Wolff GmbH & Co. KG Arzneimittel	Labor Dr. Fenner und Kollegen, Pharmaxi LLC

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Day 1 vs Day 4
Secondary	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)	Day 1 vs. Day 2,Day 1 vs. Day 4, Day 1 vs. Day 7 and Day 1 vs. Day 14
Secondary	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)	Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1
Secondary	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)	Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1
Secondary	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	Day 1 vs. Day 7 and Day 1 vs. Day 14
Secondary	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	Day 1 vs. Day 7 and Day 1 vs. Day 14
Secondary	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)	Day 1 vs. Day 7 and Day 1 vs. Day 14
Secondary	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	Day 1 vs. Day 7 and Day 1 vs. Day 14
Secondary	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	Day 1 vs. Day 4
Secondary	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	Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14
Secondary	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	Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14
Secondary	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	Day 1, Day 2, Day 3, Day 7±1, Day 14±1