Trial Outcomes & Findings for Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat (NCT NCT03095508)

Last Updated: 2019-03-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

229 participants

Primary outcome timeframe

4 Days

Results posted on

2019-03-21

Participant Flow

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.

229 patients in total were included

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	114	115
Overall Study Per Protocol Population	112	111
Overall Study Safety Population	114	115
Overall Study ITT Population	114	115
Overall Study COMPLETED	114	114
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Adverse Event	0	1

Baseline Characteristics

Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Angal S (Arm A) n=114 Participants 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	ANTI-ANGIN® FORMULA (Arm B) n=115 Participants 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	Total n=229 Participants Total of all reporting groups
Age, Continuous	31.22 Years n=5 Participants	30.54 Years n=7 Participants	30.88 Years n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	67 Participants n=7 Participants	142 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	48 Participants n=7 Participants	87 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	114 Participants n=5 Participants	115 Participants n=7 Participants	229 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 Days

Population: ITT Population

Outcome measures

Outcome measures
Measure	Angal S (Arm A) n=114 Participants 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	ANTI-ANGIN® FORMULA (Arm B) n=115 Participants 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
Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) Score 0 (no sore throat)	89.47 Percentage of Participants	75.65 Percentage of Participants
Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) Score 1	7.02 Percentage of Participants	19.13 Percentage of Participants
Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) Score 2	2.63 Percentage of Participants	4.35 Percentage of Participants
Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) Score 3	0.88 Percentage of Participants	0.87 Percentage of Participants

SECONDARY outcome

Timeframe: 4 days

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	Angal S (Arm A) n=114 Participants 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	ANTI-ANGIN® FORMULA (Arm B) n=115 Participants 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
Percentage of Participants With a ≥50% TSS Total Score Reduction	96.49 percentage of participants Interval 91.26 to 99.04	98.26 percentage of participants Interval 93.86 to 99.79

SECONDARY outcome

Timeframe: 4 days

Population: ITT population

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.

Outcome measures

Outcome measures
Measure	Angal S (Arm A) n=114 Participants 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	ANTI-ANGIN® FORMULA (Arm B) n=115 Participants 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
Change From Baseline in TSS Total Score	-6 units on a scale Interval -11.0 to 0.0	-6 units on a scale Interval -10.0 to 0.0

SECONDARY outcome

Timeframe: Group A: 4 days Group B: 5 days

Population: ITT population

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)

Outcome measures

Outcome measures
Measure	Angal S (Arm A) n=114 Participants 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	ANTI-ANGIN® FORMULA (Arm B) n=115 Participants 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
Number of Participants Who Fully Recovered	106 Participants	107 Participants

SECONDARY outcome

Timeframe: 4 days

Population: ITT population

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.

Outcome measures

Outcome measures
Measure	Angal S (Arm A) n=114 Participants 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	ANTI-ANGIN® FORMULA (Arm B) n=115 Participants 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
Change in the Sore Throat Intensity by 100 mm VAS Baseline (Visit 1)	64.76 mm Standard Deviation 16.29	65.84 mm Standard Deviation 18.36
Change in the Sore Throat Intensity by 100 mm VAS Day 4 (Visit 2)	2.99 mm Standard Deviation 10.33	5.06 mm Standard Deviation 11.06

SECONDARY outcome

Timeframe: 5 Days

Population: ITT Population (only cases with disappearance of symptoms within 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.

Outcome measures

Outcome measures
Measure	Angal S (Arm A) n=114 Participants 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	ANTI-ANGIN® FORMULA (Arm B) n=115 Participants 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
Period of Time Required for Disappearance of the Disease Symptoms	3.75 Days Standard Deviation 0.59	3.94 Days Standard Deviation 0.69

Adverse Events

Angal S (Arm A)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

ANTI-ANGIN® FORMULA (Arm B)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Study Director

Sandoz

Phone: +41613241111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However Novartis does not prohibit any inversdtigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Angal S (Arm A) n=114 participants at risk 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	ANTI-ANGIN® FORMULA (Arm B) n=115 participants at risk 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
Blood and lymphatic system disorders Leukocytosis	0.88% 1/114 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.00% 0/115 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Gastrointestinal disorders Abdominal pain upper	0.88% 1/114 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.87% 1/115 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Gastrointestinal disorders Diarrhea	0.00% 0/114 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.87% 1/115 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Gastrointestinal disorders Dyspepsia	0.88% 1/114 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.00% 0/115 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Gastrointestinal disorders Gingival pain	0.88% 1/114 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.00% 0/115 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Gastrointestinal disorders Nausea	0.88% 1/114 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.00% 0/115 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Gastrointestinal disorders Oral discomfort	0.88% 1/114 • Number of events 2 • From signing informed consent (Day 1) until completion of the trial (Day 7).	2.6% 3/115 • Number of events 3 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Gastrointestinal disorders Vomiting	0.00% 0/114 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.87% 1/115 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).
General disorders Chest pain	0.88% 1/114 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.00% 0/115 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Injury, poisoning and procedural complications Radius fracture	0.00% 0/114 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.87% 1/115 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Investigations Heart rate increased	0.00% 0/114 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.87% 1/115 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Nervous system disorders Headache	0.00% 0/114 • From signing informed consent (Day 1) until completion of the trial (Day 7).	1.7% 2/115 • Number of events 2 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Respiratory, thoracic and mediastinal disorders Cough	0.88% 1/114 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.87% 1/115 • Number of events 2 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/114 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.87% 1/115 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/114 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.87% 1/115 • Number of events 1 • From signing informed consent (Day 1) until completion of the trial (Day 7).
Respiratory, thoracic and mediastinal disorders Throat irritation	1.8% 2/114 • Number of events 3 • From signing informed consent (Day 1) until completion of the trial (Day 7).	0.00% 0/115 • From signing informed consent (Day 1) until completion of the trial (Day 7).