Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05684848 |
| Other study ID # |
LFV_PRE |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2022 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
January 2023 |
| Source |
Noos S.r.l. |
| Contact |
Michele Miraglia del Giudice, Prof |
| Phone |
0815665470 |
| Email |
Michele.MIRAGLIADELGIUDICE[@]unina2.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 five/six years of age. However, not all viral infections cause
wheezing.Numerous 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 (TNF)α, 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 autumn/winter 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.
