CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 186 enrolled
Drug / intervention
Healsea® Children +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05034328
NCT05034328N/ACompleted

Impact of Adding Healsea® Isotonic Nasal Spray to Conventional Therapies for the Care of Children With Allergic Rhinitis Presenting With Symptoms of Acute Infectious Rhinitis: an Observational Study

Lallemand Pharma AG·observational·Posted Sep 5, 2021·Updated Jan 20, 2025

In Brief

An observational study evaluating Healsea® Children and Conventional therapies for common cold for Common Cold and Allergy. Completed, enrolled 186 participants across 15 sites.

Detailed Summary

Healsea® Children is a seawater-based nasal spray supplemented with a natural Symbiofilm® extract (0.02%) isolated from marine bacteria. Symbiofilm has antibiofilm activity against various bacterial pathogens involved in respiratory tract infections.Healsea® Children is indicated in the cleaning and moistening of nasal mucosa during common cold and rhinitis for children above 6 years. This non interventional post-market clinical investigation aimed to confirm the benefit of Healsea® Children in real life setting in children with perennial allergy who are more prone to common cold.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCommon Cold, Allergy
CountriesPoland
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 5, 2021
Enrollment StartFeb 14, 2022
Primary CompletionNov 3, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.8 years ago

Interventions

Healsea® Childrendevice

Children will be administered Healsea Children , one puff (1-2 sec) in each nostril twice a day for 10 days on top of conventional therapies, as needed

Conventional therapies for common coldother

Children will receive conventional therapies for common cold, nasal irrigation excluded (antipyretics, mucolytics, decongestants, antitussives, systemic and topical corticosteroids, antibiotics)