BАbykids Spray In Common Cold

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05819203
Study type	Interventional
Source	Lallemand Pharma AG
Contact
Status	Completed
Phase	N/A
Start date	February 13, 2023
Completion date	May 16, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

BАbykids Spray In Common Cold — BASICC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms