Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05684848
Status:
RECRUITING
Last Update Posted:
2023-01-17
First Post:
2023-01-05
Brief Title:
Evaluate the Effect of Nasal Spray in the Prevention of RTI in Children With Pre-school Wheezing
Sponsor:
Noos Srl
Organization:
Noos Srl
Study Overview
Official Title:
Interventional Pilot Study to Evaluate the Effect of a Resveratrol-based Nasal Spray Associated With Carboxymethylbetaglucan in Isotonic Solution in the Prevention of RTI in Children With Pre-school Wheezing
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine whether or not preventive administration of resveratrol in the form of a nasal spray is effective in reducing the number of asthma exacerbations typical of preschool wheezing children who develop viral infections
Detailed Description:
The surface of the mucous membranes represents the first gateway for many viral agents including respiratory and intestinal ones which have the greatest epidemiological value Viruses cause damage to these epithelia and can favor bacterial superinfection as well as complications of already existing pathologies it is therefore essential to identify non-toxic substances that can hinder the entry of the virus and consequently its replication
Both wheezing and viral infections are common in children especially under the age of five In fact it is recorded that around 25 of children within nine months of age and 50 of children within six years of age have at least one episode of wheezing Wheezing in young children can have a different etiology it can be due to an underlying disease such as airway malformation internal or external airway narrowing and cystic fibrosis or it can occur without an underlying disease
In the latter case the viral infection represents one of the main causes of wheezing especially in children under fivesix years of age However not all viral infections cause wheezingNumerous studies have confirmed a correlation between viral infections and asthma exacerbations in both adults and children Furthermore new evidence suggests that viral respiratory infections in the early years of life are related to the medium- and long-term development of asthma There is ample clinical evidence demonstrating a link between early viral infections especially RV and RSV and the onset of asthma exacerbations
In addition to the viruses mentioned above enteroviruses bocaviruses parainfluenza viruses coronaviruses metapneumoviruses influenza viruses and adenoviruses also seem to be implicated
RSV respiratory syncytial virus is the most common cause of bronchiolitis in the first year of life causes hospitalization and typically circulates in temperate climates from November to April with peaks in the winter months
Although RSV has long been identified as the leading cause of childhood bronchiolitis the use of molecular techniques such as PCR has also identified rhinovirus as a causative agent of asthma exacerbations Rhinovirus which circulates year-round with peaks during the fall and spring as well as being a cause of upper respiratory tract infections has been shown in some clinical investigations to infect the lower airways to be associated with childhood bronchiolitis and become a dominant pathogen in wheezing disease as children get older
In the search for new therapeutic and prevention alternatives that can be considered a valid contribution to reduce the effects of viral infection the focus has been on effective and early treatments to help prevent the spread of the virus or to neutralize viruses at an early stage when they are lodged in the upper respiratory tract and therefore in the nose since this is the probable and first route of entry for viruses and therefore for infections
A nasal spray based on resveratol and carboxymethylbetaglucan Linfovir plus nasal spray was therefore considered which could be useful in hindering the entry of pathogens viruses and bacteria into the nasal cavities thanks to the mechanical action of the washing which goes to counter the engraftment and the consequent easier proliferation of the virus Furthermore the product contains resveratrol a substance of natural origin produced by various plants in response to stress or injury induced by microorganisms or environmental hazards which protects fruit and vegetables from fungal infections This plant extract has been widely recognized as having antioxidant properties capable of counteracting the inflammatory stages associated with pathologies of the rhinosinusal tract Patients infected with respiratory viruses in fact show an increased inflammatory state with high levels of pro-inflammatory cytokines such as tumor necrosis factor TNFα interleukin IL-6 IL-8 and interferons in the nasopharyngeal fluids and in plasma Additionally in severe viral infections reactive oxygen species ROS produced by inflammatory cells such as polymorphonuclear cells and neutrophils recruited to the site of inflammation lead to lung damage
On the basis of these assumptions an interventional randomized multicenter and controlled clinical study was designed to evaluate whether the spray solution used to hydrate and clean the nasal mucous membranes at a dosage of 2 sprays per nostril 2 times a day in prevention and 2 sprays per nostril 4 times a day in the acute phase is safe and effective in preventing and treating viral infections typical of the autumnwinter season in preschool wheezing children particularly prone to infections and asthma exacerbations Thanks to the mechanical effect of washing and through the antioxidant and anti-inflammatory efficacy of resveratrol amply demonstrated in vitro the Investigators will evaluate in the present study whether the topical administration of resveratrol at the level of the nasal district in the form of a nasal spray is able to reduce the number of days in which preschool children present symptoms attributable to respiratory infections
Both wheezing and viral infections are common in children especially under the age of five In fact it is recorded that around 25 of children within nine months of age and 50 of children within six years of age have at least one episode of wheezing Wheezing in young children can have a different etiology it can be due to an underlying disease such as airway malformation internal or external airway narrowing and cystic fibrosis or it can occur without an underlying disease
In the latter case the viral infection represents one of the main causes of wheezing especially in children under fivesix years of age However not all viral infections cause wheezingNumerous studies have confirmed a correlation between viral infections and asthma exacerbations in both adults and children Furthermore new evidence suggests that viral respiratory infections in the early years of life are related to the medium- and long-term development of asthma There is ample clinical evidence demonstrating a link between early viral infections especially RV and RSV and the onset of asthma exacerbations
In addition to the viruses mentioned above enteroviruses bocaviruses parainfluenza viruses coronaviruses metapneumoviruses influenza viruses and adenoviruses also seem to be implicated
RSV respiratory syncytial virus is the most common cause of bronchiolitis in the first year of life causes hospitalization and typically circulates in temperate climates from November to April with peaks in the winter months
Although RSV has long been identified as the leading cause of childhood bronchiolitis the use of molecular techniques such as PCR has also identified rhinovirus as a causative agent of asthma exacerbations Rhinovirus which circulates year-round with peaks during the fall and spring as well as being a cause of upper respiratory tract infections has been shown in some clinical investigations to infect the lower airways to be associated with childhood bronchiolitis and become a dominant pathogen in wheezing disease as children get older
In the search for new therapeutic and prevention alternatives that can be considered a valid contribution to reduce the effects of viral infection the focus has been on effective and early treatments to help prevent the spread of the virus or to neutralize viruses at an early stage when they are lodged in the upper respiratory tract and therefore in the nose since this is the probable and first route of entry for viruses and therefore for infections
A nasal spray based on resveratol and carboxymethylbetaglucan Linfovir plus nasal spray was therefore considered which could be useful in hindering the entry of pathogens viruses and bacteria into the nasal cavities thanks to the mechanical action of the washing which goes to counter the engraftment and the consequent easier proliferation of the virus Furthermore the product contains resveratrol a substance of natural origin produced by various plants in response to stress or injury induced by microorganisms or environmental hazards which protects fruit and vegetables from fungal infections This plant extract has been widely recognized as having antioxidant properties capable of counteracting the inflammatory stages associated with pathologies of the rhinosinusal tract Patients infected with respiratory viruses in fact show an increased inflammatory state with high levels of pro-inflammatory cytokines such as tumor necrosis factor TNFα interleukin IL-6 IL-8 and interferons in the nasopharyngeal fluids and in plasma Additionally in severe viral infections reactive oxygen species ROS produced by inflammatory cells such as polymorphonuclear cells and neutrophils recruited to the site of inflammation lead to lung damage
On the basis of these assumptions an interventional randomized multicenter and controlled clinical study was designed to evaluate whether the spray solution used to hydrate and clean the nasal mucous membranes at a dosage of 2 sprays per nostril 2 times a day in prevention and 2 sprays per nostril 4 times a day in the acute phase is safe and effective in preventing and treating viral infections typical of the autumnwinter season in preschool wheezing children particularly prone to infections and asthma exacerbations Thanks to the mechanical effect of washing and through the antioxidant and anti-inflammatory efficacy of resveratrol amply demonstrated in vitro the Investigators will evaluate in the present study whether the topical administration of resveratrol at the level of the nasal district in the form of a nasal spray is able to reduce the number of days in which preschool children present symptoms attributable to respiratory infections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None