BАbykids Spray In Common Cold

N/ACompletedNCT05819203

Lallemand Pharma AG200 enrolled

Overview

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

Conditions

Common Cold Rhinitis Viral

Interventions

Healsea BabykidsDEVICE

7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .

PlaceboDEVICE

7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .

Eligibility

Sex: ALLMin age: 25 MonthsMax age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. Male/Female subjects \>2 and ≤6-year-old * 2\. Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry * 3\. Patient presenting with fever ≥ 37.5 °C at screening * 4\. Subjects with nasal congestion (blocked / stuffy nose) rated at least as moderate on the Acute Rhinitis Symptoms Severity Questionnaire, based on evaluation by the investigator * 5\. Subjects showing at least moderate grade for at least one of the following additional signs of acute rhinitis: runny nose, nasal crust (dry mucus), sneezing and cough * 6\. Written consent obtained from parent/legal guardians Exclusion Criteria: * 1\. Known hypersensitivity/allergy to any component of the test device * 2\. Medical history that is considered by the investigator as a reason for non-inclusion, * 3\. Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps * 4\. History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores * 5\. Antibiotic intake within 2 weeks before screening * 6\. Systemic corticosteroids within 4 weeks before screening * 7\. Chronic decongestant use * 8\. Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence ARSSQ score at screening (NSAID, nasal decongestants, cough medicines)

Locations (3)

Medical center

Plovdiv, Bulgaria

Medical center

Sofia, Bulgaria

Medical center

Vratsa, Bulgaria

Outcomes

Primary Outcomes

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)

Time frame: From Day 1 to Day 10

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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