HEALSea Nasal Spray for Prevention of Infections in Children
NCT Number: NCT06582589
Acronym: HEALSPIC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Healthy Subjects
Sponsor: Lallemand Pharma AG
Sex: ALL
Age: CHILD
Enrollment: 138
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2025-03

Summary:
Healsea® Children is a class IIa medical device. This is an isotonic seawater-based nasal spray supplemented with a natural Symbiofilm™ extract (0.02%) isolated from marine bacteria. Healsea® Children is indicated in children above 6 years to clean and moisten the nose during colds.

Symbiofilm™, which is not a medicinal product is able to protect the nasal mucosa from viruses' entrance by forming a protective barrier on the nasal mucosa.

By targeting the nose as entry points for viruses, we hypothesise that Healsea® Children used regularly during the respiratory virus season may prevent upper respiratory tracts infections such as cold or flu with nasal symptoms.

The main objective of this premarket clinical investigation is thus to assess the efficacy of Healsea® Children to prevent upper respiratory tract infections with nasal symptoms in healthy children during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days when compared to children not taking Healsea® Children.

138 children will be randomised in the study, 64 in the Healsea® Children group and 64 in the non-treated group.

The subjects (or their parents) will be asked to report the upper respiratory tract infections with nasal symptoms and complication they may have during the study to the physician in charge of the study conduct.

Two study visits and 3 telephone calls are scheduled. The subjects will also complete an electronic diary to report nasal symptoms and adverse event other than upper respiratory tracts infections.

Primary Outcome Measures: Proportion of subjects without any upper respiratory tract infection (URTI) with nasal symptoms during the study., The upper respiratory tracts infections with nasal symptoms (blocked nose, runny nose yellow or green discharge, sneezing ) will be collected for each subject throughout An URTI episode with nasal symptoms is defined as follows: (i) at least 1 of the followings must be present: a blocked nose, runny nose, yellow or green nasal discharge, sneezing; (ii) the symptomatic episode must last for at least 3 days., From the randomization up to Day 116
Secondary Outcome Measures: Time to first Upper Respiratory Tract Infection with nasal symptoms during the study, The time to first Upper Respiratory Tract Infection with nasal symptoms (blocked nose, runny nose, yellow or green discharge, sneezing) will be compared between groups, From the randomization up to Day 116|Number of Upper Respiratory Tract Infections with nasal symptoms during the study, Upper Respiratory Tract Infections with nasal symptoms will be reported by the subjects to the investigators during the whole study duration and the total number compared between groups, From the randomization up to Day 116|Number of Upper Respiratory Tract Infections complications, Complications of Upper respiratory Tract Infections (bronchitis, bronchiolitis, pneumoniae, pharyngo-tonsillitis, laryngitis, acute otitis) will be reported by the subjects during the whole study duration and compared between groups, From the randomization up to Day 116|Number of days of use of concomitant treatments that may affect Upper Respiratory Tract Infections symptoms and associated complications, The number of days of antipyretics intake, systemic or local mucolytics, decongestants, antitussives, systemic and per nasal route antibiotics, local and systemic corticosteroids, systemic antivirals) will be compared between the 2 arms, From the randomization up to Day 116|Number of school days lost due to Upper Respiratory Tract Infections and complications, Number of school days lost due to Upper Respiratory Tract Infections and complications will be collected during the whole study duration and compared between groups, From the randomization up to Day 116|Assessment of (serious) adverse events and device deficiences throughout the study, From the randomization up to Day 116