Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582589
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
HEALSea Nasal Spray for Prevention of Infections in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Healsea Children Isotonic Nasal Spray in the Prevention of Upper Respiratory Tract Infections with Nasal Symptoms in Children a Pre-market Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEALSPIC
Brief Summary:
Healsea Children is a class IIa medical device This is an isotonic seawater-based nasal spray supplemented with a natural Symbiofilm extract 002 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
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
Detailed Description:
Upper respiratory tract infections URTIs and sino-nasal symptoms are very frequent
Human rhinovirus more than 100 serotypes is the most common cause accounting up to 50 viral rhinitis episodes in children and adults These episodes can last up to 7-10 days and are usually self-limited Prevalence of acute rhinosinusitis varies with season higher in the fall and winter months and climatic variations and increases with a damp environment and air pollution It is estimated that an infant can typically have up to 11 upper respiratory tract infection episodes per year with URTIs being one of the main causes of primary care consultations The number usually diminishes with age with generally around eight episodes at preschool age and four at school age
Healsea Children is a class IIa medical device This is an isotonic seawater-based nasal spray supplemented with a natural Symbiofilm extract 002 isolated from marine bacteria Healsea Children is indicated in children above 6 years to clean and moisten the nose during colds and rhinitis The clinical performance of Healsea Children is supported by the sea water solution and Symbiofilm The exact mechanisms by which nasal irrigation works are not known However most of the experts agree that it is primarily a mechanical intervention leading to direct cleaning of the nasal mucosa
The other component of Healsea Children Symbiofilm is an exopolymeric composition with emulsifyingsurfactant properties which enhance the cleansing and moistening of nasal mucosa Furthermore a prophylactic activity of Symbiofilm against infection by viruses involved in upper respiratory infections ie Adenovirus Rhinovirus Flu virus and OC 43 Coronavirus has been demonstrated in vitro on human nasal epithelial cells HNEpC The antiviral prophylactic activity of Symbiofilm is suggested to rely on its physiochemical properties that by coating the surface of epithelial cells hinders the viral entry process thus explaining the reduced viral adsorption and the subsequent reduced onset of infection
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 with nasal symptoms
The aim of this two arms prospective randomized open-labelled pre-market clinical investigation is to establish clinical benefits and clinical safety of Healsea Children to prevent upper respiratory tract infections with nasal symptoms in healthy children during 3 treatment periods of 28 days one puff in each ostril twice daily 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 immediately call the investigator in case of nasal symptoms and complication of respiratory infection they may have during the study
Two study visits Visit 1 ScreeningRandomisation at Day 1 and Visit 2 End of study visit at Day 106 up to Day 116 and 3 telephone calls telephone call 1 TC1 at Day15 3 days TC2 at Day 55 3 days and TC3 at Day 953days are scheduled The subjects will also complete an electronic diary to report nasal symptoms device deficiencies and adverse events other than upper respiratory tracts infections from D2 up to end of study Day 106 up to Day 116
The duration of patients participation is up to 116 days
Human rhinovirus more than 100 serotypes is the most common cause accounting up to 50 viral rhinitis episodes in children and adults These episodes can last up to 7-10 days and are usually self-limited Prevalence of acute rhinosinusitis varies with season higher in the fall and winter months and climatic variations and increases with a damp environment and air pollution It is estimated that an infant can typically have up to 11 upper respiratory tract infection episodes per year with URTIs being one of the main causes of primary care consultations The number usually diminishes with age with generally around eight episodes at preschool age and four at school age
Healsea Children is a class IIa medical device This is an isotonic seawater-based nasal spray supplemented with a natural Symbiofilm extract 002 isolated from marine bacteria Healsea Children is indicated in children above 6 years to clean and moisten the nose during colds and rhinitis The clinical performance of Healsea Children is supported by the sea water solution and Symbiofilm The exact mechanisms by which nasal irrigation works are not known However most of the experts agree that it is primarily a mechanical intervention leading to direct cleaning of the nasal mucosa
The other component of Healsea Children Symbiofilm is an exopolymeric composition with emulsifyingsurfactant properties which enhance the cleansing and moistening of nasal mucosa Furthermore a prophylactic activity of Symbiofilm against infection by viruses involved in upper respiratory infections ie Adenovirus Rhinovirus Flu virus and OC 43 Coronavirus has been demonstrated in vitro on human nasal epithelial cells HNEpC The antiviral prophylactic activity of Symbiofilm is suggested to rely on its physiochemical properties that by coating the surface of epithelial cells hinders the viral entry process thus explaining the reduced viral adsorption and the subsequent reduced onset of infection
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 with nasal symptoms
The aim of this two arms prospective randomized open-labelled pre-market clinical investigation is to establish clinical benefits and clinical safety of Healsea Children to prevent upper respiratory tract infections with nasal symptoms in healthy children during 3 treatment periods of 28 days one puff in each ostril twice daily 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 immediately call the investigator in case of nasal symptoms and complication of respiratory infection they may have during the study
Two study visits Visit 1 ScreeningRandomisation at Day 1 and Visit 2 End of study visit at Day 106 up to Day 116 and 3 telephone calls telephone call 1 TC1 at Day15 3 days TC2 at Day 55 3 days and TC3 at Day 953days are scheduled The subjects will also complete an electronic diary to report nasal symptoms device deficiencies and adverse events other than upper respiratory tracts infections from D2 up to end of study Day 106 up to Day 116
The duration of patients participation is up to 116 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None