The purpose of this post market clinical investigation is to demonstrate that Healsea® Babykids alleviates symptoms of the acute rhinitis phase with better efficacy than isotonic saline solution used as Placebo in children above 2 years.
Healsea® Babykids is an isotonic saline solution based nasal spray supplemented with a natural Symbiofilm® extract (0.04%) isolated from marine bacteria. Symbiofilm® has in vitro antibiofilm activity and protects in vitro human nasal epithelial cells viability after Rhinovirus, Adenovirus, coronavirus OC43 and flu infection. Healsea® Babykids is a nasal spray indicated in children above 2 years to clean and moisten the nose during colds and rhinitis. The common cold is an acute viral infection of the upper respiratory tract, involving, to variable degrees, sneezing, nasal congestion and discharge (rhinorrhea), sore throat, cough, low-grade fever, headache, and malaise. Acute viral rhinitis is generally self-limiting. In children where the illness is not self-limiting and extends beyond 7-10 days, many agree that a bacterial infection is likely. Bacterial over infections and progression to a chronic state are favoured by the formation of biofilms, which facilitate bacterial growth and persistence as well as reducing antibiotic efficacy. The aim of this study is to demonstrate that Healsea® Babykids alleviates symptoms of the acute rhinitis phase with better efficacy than isotonic saline solution used as Placebo. The study comprises 2 parts: \- Part 1 (Day 1-Day 11): treatment of the acute phase • with Healsea® Babykids, 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes of Healsea® Babykids) up to 10 days (20 intakes of the investigational device). or • with isotonic nasal spray (Placebo), 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes of Placebo) up to 10 days (20 intakes of the investigational device). \- Part 2 (up to Day 15/Day 18): follow-up phase. The study comprises two visits: * Visit 1 (V1) at Day 1 * End of study visit (Visit 2, V2) between Day 15 and Day 18
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Medical center
Plovdiv, Bulgaria
Medical center
Sofia, Bulgaria
Medical center
Vratsa, Bulgaria
The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Full Analysis Set (FAS)
ARSSQ is a non-validated customized questionnaire. It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening. The minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30).
Time frame: From Day 1 to Day 10
The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Per Protocol Set (PP)
ARSSQ is a non-validated customized questionnaire. It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening. The minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30).
Time frame: From Day 1 to Day 10
Duration of Each Cold Symptom (Questions 2 to 7 of the ARSSQ) in Both Groups
For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days. Duration may be censored at Visit 2.
Time frame: Through study completion, up to Day 18
Duration of Quality-of-life Impairment (Questions 8 to 10 of the ARSSQ).
For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days. Duration may be censored at Visit 2.
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Time frame: Through study completion, up to Day 18
Cumulative Number of Days of Concomitant Treatments Use That May Affect Common Cold Symptoms (Antibiotics, Antipyretics, Systemic or Local Mucolytics, Decongestants, Antitussives, Systemic and Topical Corticosteroids)
Concomitant treatments use (antibiotics, antipyretics, systemic or local mucolytics, decongestants, antitussives, systemic and topical corticosteroids) will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.
Time frame: Through study completion, up to Day 18
Cumulative Number of Days of Antibiotics Intake
Antibiotics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.
Time frame: through study completion , up to day 18
Cumulative Number of Days of Antipyretics Intake
Antipyretics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.
Time frame: through study completion, up to day 18
Cumulative Number of Days of Mucolytics Intake
Mucolytics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.
Time frame: Through study completion , up to day 18
Cumulative Number of Days of Decongestants Use
Decongestants use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.
Time frame: through study completion, up to day 18
Cumulative Number of Days of Antitussives Use
Antitussives use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.
Time frame: through study completion, up to day 18
Cumulative Number of Days of Systemic and Topical Corticosteroids Use
Systemic and topical corticosteroids use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.
Time frame: Through study completion, up to day 18