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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Change of the number of days with respiratory symptoms compared to placebo
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children diagnosed with wheezing
- •Patients aged between 3 and 6 years (inclusive) at the time of enrollment of both genders
- •Signature of the informed consent
- •Availability of a mobile phone capable of installing VIR@PP
排除标准
- •Inability to adequately understand the Italian language
- •Presence of autoimmune pathologies, immunodeficiency, neuromuscular diseases, congenital cardiomyopathies, metabolic diseases
- •Presence of other syndromes and genetic pathologies
- •Patients on therapy with other drugs (steroids for topical and/or oral use)
- •Abnormalities of the nose or other conditions (e.g. severe hypotonia etc...) which make the administration of a nasal spray impossible or unsafe
- •Denial of informed consent
- •Participation in other clinical studies
研究组 & 干预措施
Resveratrol + CMG
Medical device: nasal spray based on resveratrol associated with carboxymethylbetaglucan in isotonic solution
干预措施: Resveratrol + CMG (Device)
Isotonic solution
Medical Device with isotonic solution
干预措施: Isotonic solution (Device)
结局指标
主要结局
Change of the number of days with respiratory symptoms compared to placebo
时间窗: 3 months
To determine whether taking resveratrol in the form of a nasal spray changes the number of days with respiratory symptoms compared to placebo.
次要结局
- In case of exacerbations, verify the change in the number of respiratory exacerbations and their duration of the group treated with resveratrol in the form of nasal spray vs the control group.(3 months)