Sore-throat, Upper Respiratory Infection
Conditions
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.
Interventions
DEVICEVerum (WO 6607)
Mouth and throat rinse and gargle solution
DEVICEPlacebo (WO 6608)
Mouth and throat rinse and gargle solution
Sponsors
Pharmaxi LLC
Labor Dr. Fenner und Kollegen
Dr. August Wolff GmbH & Co. KG Arzneimittel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total severity score of throat irritation for subjective and objective symptoms during the clinical investigation (comparison between verum and placebo) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
| 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 | 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) |
| 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 | 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 |
| 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 | 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 |
| 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 | Comparison between Verum and Placebo: Number of patients in percent (%) having an expansion of the symptoms (e.g., subsequent bronchitis) |
| 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 | 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) |
| 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 | Comparison between Verum and Placebo: Combined nasal and oropharyngeal swab sampling for PCR detection of viruses without CT values reported for Metapneumovirus and Bocavirus |
| Global judgement of efficacy by the patient | 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 |
| Global judgement of efficacy by the investigator | 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 |
| 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 | The safety will be assessed through adverse events |
| 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 | Comparison between Verum and Placebo: Number of patients with the need for further medical intervention or treatments such as rescue therapy or pain medication |
Countries
Ukraine
Outcome results
None listed