Sore Throat
Conditions
Keywords
Angal S, 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 S, topical spray \[Menthol\], 0,5 mg + 2 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 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 S, topical spray [Menthol]
0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution
DRUGANTI-ANGIN® FORMULA, topical metered spray
0,12 mg + 0,24 mg (LLC Valeant, Russia) administered as one to two consecutive presses on the actuator button, up to 6 times 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); * Body temperature 37,5 C (axillary).
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 Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | 4 Days | The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a ≥50% TSS Total Score Reduction | 4 days | Percentage of participants with a ≥50% TSS Total Score Reduction according to the TSS questionnaire completed by the Investigator as compared to the baseline. The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15. |
| Change From Baseline in TSS Total Score | 4 days | Change from baseline in TSS total score completed by the Investigator as compared to the baseline. The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15. |
| Number of Participants Who Fully Recovered | Group A: 4 days Group B: 5 days | Number of Participants who Fully Recovered by Day 4 in Group A and by Day 5 in Group B (the outcome of a disease according to the objective evaluation by the Investigator, the total score according to the TSS questionnaire ≤ 2) |
| Change in the Sore Throat Intensity by 100 mm VAS | 4 days | Change in the sore throat intensity by 100 mm VAS (visual analogue scale filled in by the patient) at the start and after 3 days of therapy. 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. |
| Period of Time Required for Disappearance of the Disease Symptoms | 5 Days | A period of time required for disappearance of the disease symptoms, determined according to the patient's diary (subjective patient's evaluation), but no more than 5 days during the trial-for patients who have achieved the corresponding outcome. |
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
229 patients in total were included
Participants by arm
| Arm | Count |
|---|---|
| Angal S (Arm A) Patients received Angal S, topical spray \[Menthol\], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution | 114 |
| ANTI-ANGIN® FORMULA (Arm B) Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC Valeant, Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution | 115 |
| Total | 229 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Angal S (Arm A) | ANTI-ANGIN® FORMULA (Arm B) |
|---|---|---|---|
| Age, Continuous | 30.88 Years | 31.22 Years | 30.54 Years |
| Race/Ethnicity, Customized Caucasian | 229 Participants | 114 Participants | 115 Participants |
| Sex: Female, Male Female | 142 Participants | 75 Participants | 67 Participants |
| Sex: Female, Male Male | 87 Participants | 39 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 114 | 0 / 115 |
| other Total, other adverse events | 7 / 114 | 11 / 115 |
| serious Total, serious adverse events | 0 / 114 | 0 / 115 |
Outcome results
Primary
Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS)
The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15.
Time frame: 4 Days
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Angal S (Arm A) | Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | Score 1 | 7.02 Percentage of Participants |
| Angal S (Arm A) | Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | Score 3 | 0.88 Percentage of Participants |
| Angal S (Arm A) | Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | Score 2 | 2.63 Percentage of Participants |
| Angal S (Arm A) | Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | Score 0 (no sore throat) | 89.47 Percentage of Participants |
| ANTI-ANGIN® FORMULA (Arm B) | Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | Score 2 | 4.35 Percentage of Participants |
| ANTI-ANGIN® FORMULA (Arm B) | Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | Score 1 | 19.13 Percentage of Participants |
| ANTI-ANGIN® FORMULA (Arm B) | Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | Score 0 (no sore throat) | 75.65 Percentage of Participants |
| ANTI-ANGIN® FORMULA (Arm B) | Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | Score 3 | 0.87 Percentage of Participants |
Comparison: p1=proportion of patients without sore throat at Day 4 in Arm A p2=proportion of patients without sore throat at Day 4 in Arm B Н0: p1 - p2 ≤ -0.145p-value: 0.0000195% CI: [0.03, 0.24]Fisher Exact
Secondary
Change From Baseline in TSS Total Score
Change from baseline in TSS total score completed by the Investigator as compared to the baseline. The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15.
Time frame: 4 days
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Angal S (Arm A) | Change From Baseline in TSS Total Score | -6 units on a scale |
| ANTI-ANGIN® FORMULA (Arm B) | Change From Baseline in TSS Total Score | -6 units on a scale |
Secondary
Change in the Sore Throat Intensity by 100 mm VAS
Change in the sore throat intensity by 100 mm VAS (visual analogue scale filled in by the patient) at the start and after 3 days of therapy. 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: 4 days
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Angal S (Arm A) | Change in the Sore Throat Intensity by 100 mm VAS | Baseline (Visit 1) | 64.76 mm | Standard Deviation 16.29 |
| Angal S (Arm A) | Change in the Sore Throat Intensity by 100 mm VAS | Day 4 (Visit 2) | 2.99 mm | Standard Deviation 10.33 |
| ANTI-ANGIN® FORMULA (Arm B) | Change in the Sore Throat Intensity by 100 mm VAS | Day 4 (Visit 2) | 5.06 mm | Standard Deviation 11.06 |
| ANTI-ANGIN® FORMULA (Arm B) | Change in the Sore Throat Intensity by 100 mm VAS | Baseline (Visit 1) | 65.84 mm | Standard Deviation 18.36 |
p-value: 0.145t-test, 2 sided
Secondary
Number of Participants Who Fully Recovered
Number of Participants who Fully Recovered by Day 4 in Group A and by Day 5 in Group B (the outcome of a disease according to the objective evaluation by the Investigator, the total score according to the TSS questionnaire ≤ 2)
Time frame: Group A: 4 days Group B: 5 days
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Angal S (Arm A) | Number of Participants Who Fully Recovered | 106 Participants |
| ANTI-ANGIN® FORMULA (Arm B) | Number of Participants Who Fully Recovered | 107 Participants |
p-value: 1Fisher Exact
Secondary
Percentage of Participants With a ≥50% TSS Total Score Reduction
Percentage of participants with a ≥50% TSS Total Score Reduction according to the TSS questionnaire completed by the Investigator as compared to the baseline. The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15.
Time frame: 4 days
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Angal S (Arm A) | Percentage of Participants With a ≥50% TSS Total Score Reduction | 96.49 percentage of participants |
| ANTI-ANGIN® FORMULA (Arm B) | Percentage of Participants With a ≥50% TSS Total Score Reduction | 98.26 percentage of participants |
p-value: 0.446Fisher Exact
Secondary
Period of Time Required for Disappearance of the Disease Symptoms
A period of time required for disappearance of the disease symptoms, determined according to the patient's diary (subjective patient's evaluation), but no more than 5 days during the trial-for patients who have achieved the corresponding outcome.
Time frame: 5 Days
Population: ITT Population (only cases with disappearance of symptoms within 5 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Angal S (Arm A) | Period of Time Required for Disappearance of the Disease Symptoms | 3.75 Days | Standard Deviation 0.59 |
| ANTI-ANGIN® FORMULA (Arm B) | Period of Time Required for Disappearance of the Disease Symptoms | 3.94 Days | Standard Deviation 0.69 |
p-value: 0.188Wilcoxon (Mann-Whitney)