Safety and Efficacy of the Sore Throat Lozenges to Treat Acute Sore Throats

Respiratory Tract Infection Viral Clinical Trial

Official title:

Open Clinical Trial to Assess Safety and Efficacy of the Sore Throat Lozenges in Patients With Acute Sore Throats

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04139681
• Other study ID #: 5'000'196
• Status: Completed
• Phase: Phase 4
• Start date: March 12, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: August 2021
• Source: A. Vogel AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 15, 2020
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharyngitis
• Respiratory Tract Infection Viral
• Respiratory Tract Infections
• Tonsillopharyngitis
• Virus Diseases

Intervention

Drug:
• A. Vogels Sore Throat lozenges
5 times 1 A. Vogels sore throat lozenges daily for 4 days

Locations

Country	Name	City	State
Bulgaria	Diagnostics and Consultation Center Convex EOOD	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
A. Vogel AG

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 days
Secondary	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	90 min
Secondary	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.	4 days
Secondary	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.	4 days
Secondary	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	4 days
Secondary	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	4 days
Secondary	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	4 days
Secondary	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.	4 days
Secondary	The average time to symptom resolution2	The average time required for subjective symptom resolution	4 days
Secondary	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	4 days
Secondary	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.	4 days
Secondary	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"	4 days
Secondary	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.	4 days
Secondary	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	4 days
Secondary	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"	4 days
Secondary	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	4 days
Secondary	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	4 days