Safety and Efficacy of the Sore Throat Lozenges to Treat Acute Sore Throats
Primary Purpose
Tonsillopharyngitis, Respiratory Tract Infection Viral
Status
Completed
Phase
Phase 4
Locations
Bulgaria
Study Type
Interventional
Intervention
A. Vogels Sore Throat lozenges
Sponsored by
About this trial
This is an interventional treatment trial for Tonsillopharyngitis
Eligibility Criteria
Inclusion Criteria:
- Men and women aged 12-75 years
- Acute pharyngitis or tonsillitis with the following symptoms: Sore throat, Inflammation of the pharynx and/or tonsils
- Start of painful disease with the last 48 hours before study inclusion
- Tonsillopharyngitis Score bigger than or equal to 6 (s.attachment)
- Willingness to give blood samples and three viral throat swabs
- Written informed consent
Exclusion Criteria:
- Pharyngitis or tonsillitis more than 48 hours before study start (inclusion)
- Intake of analgetically active medication within the last 12 hours prior to study start (inclusion)
- Use of local sore throat medications within the last 4 hours prior to study start (inclusion)
- Patients with symptoms of a primary bacterial pharyngitis or a bacterial superinfection
- Severe medical condition (tumors, uncontrolled hypertension, heart insufficiency, immunosuppressive diseases etc.)
- Systemic use of corticosteroids in the last month prior to study inclusion
- Allergies to substances used in the tablet
- Pregnancy or lactation
- Participation or inclusion in one or more clinical trials within the last 30 days
Sites / Locations
- Diagnostics and Consultation Center Convex EOOD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A. Vogels Sore Throat Lozenges
Arm Description
Each patients receives 1 glass containing 20 A.Vogel Sore Throat lozenges at inclusion visit 1. They first suck under supervision in the study centre one Vogel Sore Throat lozenge and document every 15 minutes the pain 90 minutes. Patients will receive the rest of the bottle still containing 19 Vogel Sore Throat lozenges and have to take them for 4 days (5 lozenges per day, throughout the day) and record tonsillitis pain.
Outcomes
Primary Outcome Measures
Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" tolerability ratings as assessment by a physician
Assessment of safety after acute intake of 90 minutes at visit 1 and after 4 days of continous intake at final visit 2 by physician with very good, good, moderate, bad
Secondary Outcome Measures
Change of acute throat pain on a visual analog scale (VAS)
Change of acute throat pain (pain reduction) on a visual analog scale (VAS) ranging from 0 millimeters (no pain) to 100 millimeters (most severe pain) within 90 minutes compared to baseline
Rate and number of treatment responders at day 1,2,3,4
Rate and number of Treatment responders expressed on a Tonsillopharyngitis Score (TSS) measuring change of sore throat symptoms at day 1,2,3,4 (Responder=TSS reduction by 50% compared to baseline). The TSS score consists the following four symptoms: throat pain, difficulty in swallowing, salivation, reddening and fever (fever was defined as >38.5°C for this score) which are all rated on a scale with 0=none, 1=mild, 2=moderate, 3=severe.
Total change of Tonsillopharyngitis Score (TSS) at the end of treatment
Change of Tonsillopharyngitis Score (TSS) total at the end of treatment at day 4 as compared to baseline measurement. The TSS score consists the following four symptoms: throat pain, difficulty in swallowing, salivation, reddening and fever (fever was defined as >38.5°C for this score) which are all rated on a scale with 0=none, 1=mild, 2=moderate, 3=severe.
Total reduction of pain score
Change of acute throat pain (pain reduction) on a visual analog scale (VAS) ranging from 0 millimeters (no pain) to 100 millimeters (most severe pain) on the evenings of day 1,2,3,4 compared to baseline
Absolute and relative distribution of individual Tonsillopharyngitis Score (TSS) symptoms
Absolute and relative distribution of the single symptoms: throat pain, difficulty in swallowing, salivation, reddening and fever (fever was defined as >38.5°C for this score) from the Tonsillopharyngitis Score (TSS) on day 1,2,3,4 compared to baseline
The relative number of painfree patients
The relative number of painfree patients that experience a change of acute throat pain (pain reduction) on a visual analog scale (VAS) ranging from 0 millimeters (no pain) to 100 millimeters (most severe pain) of lower than 10 (<10) at day 1,2,3,4 compared to baseline
The average time taken to symptom resolution1
The time taken to symptom resolution reaching a Tonsillopharyngitis Score (TSS) of less than 3 (<3). The TSS score consists the following four symptoms: throat pain, difficulty in swallowing, salivation, reddening and fever (fever was defined as >38.5°C for this score) which are all rated on a scale with 0=none, 1=mild, 2=moderate, 3=severe.
The average time to symptom resolution2
The average time required for subjective symptom resolution
The rate and kind of concomitant medication use
The rate of use and kind of concomitant medication that are used by patients are recorded by questionaire as part of the patient diary and analyzed in descriptive manner
The throat status as assessed by the investigating physician
Throat status (reddening, swelling, inflammation) assessed by physician. Assessed are: The presence of reddening in the throat (yes/no) and swelling (light, moderate, severe) and reddening, swelling, and coating of the tonsils (yes/no). beginning vs. after 90 minutes of treatment vs. 4 days of treatment.
Rate of "good" and "very good" efficacy ratings vs. "moderate" and "bad" efficacy ratings as assessment by a 1) physician 2) the patient
Global subjective assessment of the subjective efficacy after acute intake of 90 minutes at visit 1 and after 4 days of continous intake at final visit 2 rated 1) by physician and 2) by the patient with "very good", "good", "moderate", "bad"
Rate of treatment acceptance (yes) by the patient
The rate of treatment acceptance assessed by asking patients if they would retake the IMP (yes) or refuse (no) at final visit 2.
The rate and kind of occuring adverse events
The rate and kind of occuring adverse events assessed at visit 2 and analyzed in descriptive manner
Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" efficacy ratings as assessment by the patient
Global subjective assessment of the subjective tolerability after acute intake of 90 minutes at visit 1 and after 4 days of continous intake at final visit 2 rated by the patient with "very good", "good", "moderate", "bad"
Rate and kind of clinically relevant changes in vital parameters as assed by physical examination by the investigating physician
Rate and kind of clinically relevant changes in vital parameters (pulse, both blood pressure, body temperature) derived from exhamination by investigating physician at inclusion visit 1 and at final visit 2
Rate and kind of clinically relevant changes in blood parameters examined by the investigating physician
Rate and kind of clinically relevant changes in blood parameters measured from haematological and biochemical analysis of blood samples analyses as asssessed by the investigating physician. Laboratory blood values that are measured: ALAT, ASAT, total bilirubin, plasma glucose, serum creatinine, ESR (1h), CRP, total cholesterol, erythrocytes, MCHC, MCH, MCV, hematocrit, hemoglobin, leukocytes, and thrombocytes] derived from clinical laboratory analyses and assessed by investigating physician at visit 1 and compared to measurements at final visit 2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04139681
Brief Title
Safety and Efficacy of the Sore Throat Lozenges to Treat Acute Sore Throats
Official Title
Open Clinical Trial to Assess Safety and Efficacy of the Sore Throat Lozenges in Patients With Acute Sore Throats
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
April 26, 2019 (Actual)
Study Completion Date
March 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
A. Vogel AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of this study is to investigate safety and efficacy of A. Vogel Sore throat lozenges for the treatment of of acute sore throats
Detailed Description
75 patients aged 12-75 years with acute sore throats (symptoms not older than 48 h) were recruited by the study site/CRO via local general practitioners and are allocated to acute treatment with A. Vogel Sore throat lozenges. The patients who are confirmed to meet the study entry criteria and after having given written informed consent will be assigned to receive a study treatment according to study procedures described in the study plan.
The patients will visit study site twice. At the first visit (Visit 1) a screening will be performed to finally decide if patient will be included/excluded in the study. Then he or she will be taking one single lozenge under supervision of the investigating physician and acute efficacy/safety ratings recorded before intake and repeatedly every 15 minutes for 90 minutes after intake of first lozenge. He or she will be supplied with the remaining 19 lozenges in a bottle and provided with patient diaries for home recording of efficacy/safety. After four days (max 5 days) or until complete resolution of symptoms the patients were obliged to return to the study centre for final visit 2. Daily ratings of efficacy/safety was done by the patient once in the morning and once in the evening. Daily dosage was 5 lozenges per day every 3rd hour during daytime.
At final visit 2, patients will be evaluated physically by the physician at the study centre and again assessed for safety/efficacy parameters. At last, patients returned their patient diaries and remaining study medication before compensation is handed out and patients finally excluded from the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillopharyngitis, Respiratory Tract Infection Viral
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Eligible patients fulfilling the inclusion criteria will :
First suck under supervision in the study centre one lozenge and document every 15 minutes the pain on a 100mmVAS for 90 minutes
Receive the rest of the bottle still containing 19 lozenges and have to take them for 4 days (5 lozenges per day). The patients have to fill out a diary in the morning and in the evening filling out the Tonsillopharyngitis Score (TSS), pain on a 100mm VAS and occurrence of adverse events, intake of other medication.
After the end of the treatment period patients will return to the study centre for the final visit
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A. Vogels Sore Throat Lozenges
Arm Type
Experimental
Arm Description
Each patients receives 1 glass containing 20 A.Vogel Sore Throat lozenges at inclusion visit 1. They first suck under supervision in the study centre one Vogel Sore Throat lozenge and document every 15 minutes the pain 90 minutes. Patients will receive the rest of the bottle still containing 19 Vogel Sore Throat lozenges and have to take them for 4 days (5 lozenges per day, throughout the day) and record tonsillitis pain.
Intervention Type
Drug
Intervention Name(s)
A. Vogels Sore Throat lozenges
Other Intervention Name(s)
Sore Throat lozenges
Intervention Description
5 times 1 A. Vogels sore throat lozenges daily for 4 days
Primary Outcome Measure Information:
Title
Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" tolerability ratings as assessment by a physician
Description
Assessment of safety after acute intake of 90 minutes at visit 1 and after 4 days of continous intake at final visit 2 by physician with very good, good, moderate, bad
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Change of acute throat pain on a visual analog scale (VAS)
Description
Change of acute throat pain (pain reduction) on a visual analog scale (VAS) ranging from 0 millimeters (no pain) to 100 millimeters (most severe pain) within 90 minutes compared to baseline
Time Frame
90 min
Title
Rate and number of treatment responders at day 1,2,3,4
Description
Rate and number of Treatment responders expressed on a Tonsillopharyngitis Score (TSS) measuring change of sore throat symptoms at day 1,2,3,4 (Responder=TSS reduction by 50% compared to baseline). The TSS score consists the following four symptoms: throat pain, difficulty in swallowing, salivation, reddening and fever (fever was defined as >38.5°C for this score) which are all rated on a scale with 0=none, 1=mild, 2=moderate, 3=severe.
Time Frame
4 days
Title
Total change of Tonsillopharyngitis Score (TSS) at the end of treatment
Description
Change of Tonsillopharyngitis Score (TSS) total at the end of treatment at day 4 as compared to baseline measurement. The TSS score consists the following four symptoms: throat pain, difficulty in swallowing, salivation, reddening and fever (fever was defined as >38.5°C for this score) which are all rated on a scale with 0=none, 1=mild, 2=moderate, 3=severe.
Time Frame
4 days
Title
Total reduction of pain score
Description
Change of acute throat pain (pain reduction) on a visual analog scale (VAS) ranging from 0 millimeters (no pain) to 100 millimeters (most severe pain) on the evenings of day 1,2,3,4 compared to baseline
Time Frame
4 days
Title
Absolute and relative distribution of individual Tonsillopharyngitis Score (TSS) symptoms
Description
Absolute and relative distribution of the single symptoms: throat pain, difficulty in swallowing, salivation, reddening and fever (fever was defined as >38.5°C for this score) from the Tonsillopharyngitis Score (TSS) on day 1,2,3,4 compared to baseline
Time Frame
4 days
Title
The relative number of painfree patients
Description
The relative number of painfree patients that experience a change of acute throat pain (pain reduction) on a visual analog scale (VAS) ranging from 0 millimeters (no pain) to 100 millimeters (most severe pain) of lower than 10 (<10) at day 1,2,3,4 compared to baseline
Time Frame
4 days
Title
The average time taken to symptom resolution1
Description
The time taken to symptom resolution reaching a Tonsillopharyngitis Score (TSS) of less than 3 (<3). The TSS score consists the following four symptoms: throat pain, difficulty in swallowing, salivation, reddening and fever (fever was defined as >38.5°C for this score) which are all rated on a scale with 0=none, 1=mild, 2=moderate, 3=severe.
Time Frame
4 days
Title
The average time to symptom resolution2
Description
The average time required for subjective symptom resolution
Time Frame
4 days
Title
The rate and kind of concomitant medication use
Description
The rate of use and kind of concomitant medication that are used by patients are recorded by questionaire as part of the patient diary and analyzed in descriptive manner
Time Frame
4 days
Title
The throat status as assessed by the investigating physician
Description
Throat status (reddening, swelling, inflammation) assessed by physician. Assessed are: The presence of reddening in the throat (yes/no) and swelling (light, moderate, severe) and reddening, swelling, and coating of the tonsils (yes/no). beginning vs. after 90 minutes of treatment vs. 4 days of treatment.
Time Frame
4 days
Title
Rate of "good" and "very good" efficacy ratings vs. "moderate" and "bad" efficacy ratings as assessment by a 1) physician 2) the patient
Description
Global subjective assessment of the subjective efficacy after acute intake of 90 minutes at visit 1 and after 4 days of continous intake at final visit 2 rated 1) by physician and 2) by the patient with "very good", "good", "moderate", "bad"
Time Frame
4 days
Title
Rate of treatment acceptance (yes) by the patient
Description
The rate of treatment acceptance assessed by asking patients if they would retake the IMP (yes) or refuse (no) at final visit 2.
Time Frame
4 days
Title
The rate and kind of occuring adverse events
Description
The rate and kind of occuring adverse events assessed at visit 2 and analyzed in descriptive manner
Time Frame
4 days
Title
Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" efficacy ratings as assessment by the patient
Description
Global subjective assessment of the subjective tolerability after acute intake of 90 minutes at visit 1 and after 4 days of continous intake at final visit 2 rated by the patient with "very good", "good", "moderate", "bad"
Time Frame
4 days
Title
Rate and kind of clinically relevant changes in vital parameters as assed by physical examination by the investigating physician
Description
Rate and kind of clinically relevant changes in vital parameters (pulse, both blood pressure, body temperature) derived from exhamination by investigating physician at inclusion visit 1 and at final visit 2
Time Frame
4 days
Title
Rate and kind of clinically relevant changes in blood parameters examined by the investigating physician
Description
Rate and kind of clinically relevant changes in blood parameters measured from haematological and biochemical analysis of blood samples analyses as asssessed by the investigating physician. Laboratory blood values that are measured: ALAT, ASAT, total bilirubin, plasma glucose, serum creatinine, ESR (1h), CRP, total cholesterol, erythrocytes, MCHC, MCH, MCV, hematocrit, hemoglobin, leukocytes, and thrombocytes] derived from clinical laboratory analyses and assessed by investigating physician at visit 1 and compared to measurements at final visit 2
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women aged 12-75 years
Acute pharyngitis or tonsillitis with the following symptoms: Sore throat, Inflammation of the pharynx and/or tonsils
Start of painful disease with the last 48 hours before study inclusion
Tonsillopharyngitis Score bigger than or equal to 6 (s.attachment)
Willingness to give blood samples and three viral throat swabs
Written informed consent
Exclusion Criteria:
Pharyngitis or tonsillitis more than 48 hours before study start (inclusion)
Intake of analgetically active medication within the last 12 hours prior to study start (inclusion)
Use of local sore throat medications within the last 4 hours prior to study start (inclusion)
Patients with symptoms of a primary bacterial pharyngitis or a bacterial superinfection
Severe medical condition (tumors, uncontrolled hypertension, heart insufficiency, immunosuppressive diseases etc.)
Systemic use of corticosteroids in the last month prior to study inclusion
Allergies to substances used in the tablet
Pregnancy or lactation
Participation or inclusion in one or more clinical trials within the last 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandar Buchkov, Dr. med.
Organizational Affiliation
Diagnostics and Consultation Center Convex
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diagnostics and Consultation Center Convex EOOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of the Sore Throat Lozenges to Treat Acute Sore Throats
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