NCT05819203

BАbykids Spray In Common Cold

Efficacy and Safety of Healsea® Babykids in the Treatment of Acute Infectious Rhinitis Symptoms in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Lallemand Pharma AG · Industry
• Sex: All
• Age: 25 Months – 6 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Common Cold
• Rhinitis Viral

Interventions

Type	Name	Description
DEVICE	Healsea Babykids	7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
DEVICE	Placebo	7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .

Timeline

• Start date: 2023-02-13
• Primary completion: 2023-05-16
• Completion: 2023-05-16
• First posted: 2023-04-19
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

3 sites across 1 country: Bulgaria