Sore Throat
Conditions
Keywords
Angal, ANTI-ANGIN® FORMULA, sore throat, no less therapeutic efficacy
Brief summary
The purpose of this study was to evaluate no less therapeutic efficacy and safety of the Angal, lozenges \[Menthol\], 1 mg + 5 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, lozenges, 0,2 mg + 2 mg + 50 mg (LLC Valeant, Russia) in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat.
Interventions
DRUGAngal, lozenges [menthol],
Angal, administered per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution.
DRUGANTI-ANGIN® FORMULA
0,2 mg + 2 mg + 50 mg (LLC Valeant, Russia). Administered per 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution.
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Voluntarily signed informed consent for participation in this clinical study; 18 to 45 years old inclusive, male and female; * Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat; * Onset of first symptoms of the uncomplicated acute infectious and inflammatory diseases of the pharynx (pharyngitis and/or tonsillitis) less than 48 hours prior to inclusion into the study; * Baseline TSS score (Tonsillopharyngitis Severity Score) ≥ 5 (total score);
Exclusion criteria
* Use of analgesics within \<12 hours prior to the study start or/and inability to cancel them during the study; * Use of antibiotics within \<48 hours prior to the study start or/and inability to cancel them during the study; * Use of local therapy (sprays, rinses, lozenges) to pharynx within \<12 hours before study start or/and inability to cancel them, besides study medications. * Use systemic or inhaled corticosteroids within ≤1 months prior to the study start and planned therapy of them during the study (besides skin means). * Presence of symptoms of primary bacterial pharyngitis or secondary bacterial infection (including fever over 37,5 ° C, the presence of purulent raids in the throat, severe intoxication, leukocytosis, neutrophilia, shift leukocyte left (increasing the percentage of neutrophils sticks appearance younger forms of neutrophils), increased ESR 30 mm/hr);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Without Sore Throat According to TSS Score | 4 days | TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale: 0 : no symptoms 1. : insignificant symptom 2. : moderate symptom 3. : significant symptom fever 0 pts : \<37.5 °С; 1. pts : 37.5 to \<38.5 °С; 2. pts : 38.5 to \<39.5 °С; 3. pts : ≥ 39.5 °С. TSS total ranges are 0-15. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 50% Reduction Tss SCORE | day 4 | Frequency of 50 % or more total score reduction by the TSS questionnaire completed by the Investigator relative to baseline in both Angal and ANTI-ANGIN FORMULA arms at visit 2 |
| Change From Baseline in TSS Total Score | baseline and day 4 | Change from baseline in TSS total score. A negative change from baseline means an improvement.TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale: 0 : no symptoms 1. : insignificant symptom 2. : moderate symptom 3. : significant symptom fever 0 pts : \<37.5 °С; 1. pts : 37.5 to \<38.5 °С; 2. pts : 38.5 to \<39.5 °С; 3. pts : ≥ 39.5 °С. TSS total ranges are 0-15. |
| Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient) | 5 days | only patients for which outcomes were available were included , 111 out of 113 for Angal and 102 out of 107 for Antiangin, per protocol set |
| Number of Participants Who Fully Recovered up to Day 5 | 4 days for Angal, 5 days for AntiAngin | Number of participants who fully recovered up to day 5 (the outcome of a disease according to the objective evaluation by the Investigator, the total score according to the TSS questionnaire ≤ 2) |
| Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) . | baseline, day 4 | The VAS is a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of no pain at all and worst pain imaginable. The VAS ranges from 0 to 100. A decrease from baseline in the VAS score to reflect pain intensity indicates a decrease in pain intensity. |
Countries
Russia
Participant flow
Recruitment details
The trial included a screening period, up to 5 days active treatment, and follow-up visit. The patients had to visit the trial site up to 3 times.
Pre-assignment details
228 patients in total were included
Participants by arm
| Arm | Count |
|---|---|
| ANGAL Patients received Angal, lozenges, per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution, if happened earlier than 4th day of treatment. | 115 |
| ANTIANGIN Patients received ANTIANGIN ® FORMULA, 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution, if happened earlier than 5th day of treatment. | 113 |
| Total | 228 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | ANTIANGIN | Total | ANGAL |
|---|---|---|---|
| Age, Continuous | 30.02 years | 30.23 years | 30.44 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 113 Participants | 228 Participants | 115 Participants |
| Sex: Female, Male Female | 67 Participants | 140 Participants | 73 Participants |
| Sex: Female, Male Male | 46 Participants | 88 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 115 | 0 / 113 |
| other Total, other adverse events | 6 / 115 | 12 / 113 |
| serious Total, serious adverse events | 0 / 115 | 0 / 113 |
Outcome results
Primary
Percentage of Participants Without Sore Throat According to TSS Score
TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale: 0 : no symptoms 1. : insignificant symptom 2. : moderate symptom 3. : significant symptom fever 0 pts : \<37.5 °С; 1. pts : 37.5 to \<38.5 °С; 2. pts : 38.5 to \<39.5 °С; 3. pts : ≥ 39.5 °С. TSS total ranges are 0-15.
Time frame: 4 days
Population: ITT, only patients with measurements were included (115 for Angal, and 112 for Antiangin)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ANGAL | Percentage of Participants Without Sore Throat According to TSS Score | sore throat TSS score 0 | 84.35 percentage of participants |
| ANGAL | Percentage of Participants Without Sore Throat According to TSS Score | sore throat TSS score 1 | 13.91 percentage of participants |
| ANGAL | Percentage of Participants Without Sore Throat According to TSS Score | sore throat TSS score 3 | 0 percentage of participants |
| ANGAL | Percentage of Participants Without Sore Throat According to TSS Score | sore throat TSS score 2 | 1.74 percentage of participants |
| ANTIANGIN | Percentage of Participants Without Sore Throat According to TSS Score | sore throat TSS score 2 | 8.93 percentage of participants |
| ANTIANGIN | Percentage of Participants Without Sore Throat According to TSS Score | sore throat TSS score 0 | 73.21 percentage of participants |
| ANTIANGIN | Percentage of Participants Without Sore Throat According to TSS Score | sore throat TSS score 3 | 0 percentage of participants |
| ANTIANGIN | Percentage of Participants Without Sore Throat According to TSS Score | sore throat TSS score 1 | 17.86 percentage of participants |
Comparison: Arm Angal, Arm Antianginp-value: 0.028Fisher Exact
Secondary
50% Reduction Tss SCORE
Frequency of 50 % or more total score reduction by the TSS questionnaire completed by the Investigator relative to baseline in both Angal and ANTI-ANGIN FORMULA arms at visit 2
Time frame: day 4
Population: PP set was considered for the analysis, however only the number of patients with complete data at visit 2 were considered for the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ANGAL | 50% Reduction Tss SCORE | 97.35 percentage of participants |
| ANTIANGIN | 50% Reduction Tss SCORE | 98.13 percentage of participants |
Secondary
Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) .
The VAS is a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of no pain at all and worst pain imaginable. The VAS ranges from 0 to 100. A decrease from baseline in the VAS score to reflect pain intensity indicates a decrease in pain intensity.
Time frame: baseline, day 4
Population: PP, participants with measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ANGAL | Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) . | Baseline | 66.38 millimeters | Standard Deviation 17.6 |
| ANGAL | Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) . | day 4 | 2.35 millimeters | Standard Deviation 7.96 |
| ANTIANGIN | Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) . | Baseline | 66.99 millimeters | Standard Deviation 18.03 |
| ANTIANGIN | Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) . | day 4 | 4.67 millimeters | Standard Deviation 10.67 |
Comparison: change from baseline, 2 groupsp-value: 0.072t-test, 2 sided
Secondary
Change From Baseline in TSS Total Score
Change from baseline in TSS total score. A negative change from baseline means an improvement.TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale: 0 : no symptoms 1. : insignificant symptom 2. : moderate symptom 3. : significant symptom fever 0 pts : \<37.5 °С; 1. pts : 37.5 to \<38.5 °С; 2. pts : 38.5 to \<39.5 °С; 3. pts : ≥ 39.5 °С. TSS total ranges are 0-15.
Time frame: baseline and day 4
Population: PP
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ANGAL | Change From Baseline in TSS Total Score | baseline | 6.88 unit on a scale |
| ANGAL | Change From Baseline in TSS Total Score | day 4 | 0.45 unit on a scale |
| ANTIANGIN | Change From Baseline in TSS Total Score | baseline | 7.03 unit on a scale |
| ANTIANGIN | Change From Baseline in TSS Total Score | day 4 | 0.83 unit on a scale |
Secondary
Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient)
only patients for which outcomes were available were included , 111 out of 113 for Angal and 102 out of 107 for Antiangin, per protocol set
Time frame: 5 days
Population: PP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ANGAL | Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient) | 3.75 days | Standard Error 0.049 |
| ANTIANGIN | Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient) | 3.93 days | Standard Error 0.059 |
p-value: 0.482Wilcoxon (Mann-Whitney)
Secondary
Number of Participants Who Fully Recovered up to Day 5
Number of participants who fully recovered up to day 5 (the outcome of a disease according to the objective evaluation by the Investigator, the total score according to the TSS questionnaire ≤ 2)
Time frame: 4 days for Angal, 5 days for AntiAngin
Population: PP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ANGAL | Number of Participants Who Fully Recovered up to Day 5 | 102 participants |
| ANTIANGIN | Number of Participants Who Fully Recovered up to Day 5 | 104 participants |