BАbykids Spray In Common Cold

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-13

Study Completion Date

2023-05-16

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Common Cold Rhinitis Viral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial double blind

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The investigational device and the comparator were indistinguishable. The comparator (isotonic nasal spray) used the same technology and the same packaging than Healsea Babykids. A white label with regulatory mentions for clinical investigations was stuck on the vial A white label with regulatory mentions was sticked on a white cardboard box used as secondary packaging. The IFUs (Bulgarian version) was included in the secondary packaging (on one face, Healsea Babykids, on the other face Placebo

Study Groups

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Healsea Babykids

Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).

Group Type EXPERIMENTAL

Healsea Babykids

Intervention Type DEVICE

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

Placebo

The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.

Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

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

Interventions

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Healsea Babykids

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

Intervention Type DEVICE

Placebo

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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

25 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No