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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 16
- 主要终点
- Proportion of subjects without any upper respiratory tract infection (URTI) with nasal symptoms during the study.
研究概览
简要总结
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.
详细描述
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 (0.02%) 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 emulsifying/surfactant 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 i.e., 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.
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
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/Female subjects ≥6 and <18-year-old
- •No respiratory tract infection within 15 days before trial entry and at trial entry
- •Written consent obtained from parent/legal guardians
- •Written assent obtained from patient
- •Availability of a smartphone throughout the study and an internet connection.-
排除标准
- •Known hypersensitivity/allergy to any component of the test device,
- •Subject with severe asthma, perennial allergy, cystic fibrosis, immunodeficiency or ciliary dyskinesis,
- •Body temperature ≥ 37.5°
- •Medical history or any current disease that is considered by the investigator as a reason for non-inclusion,
- •Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps,
- •Antibiotic (systemic or per nasal route) or antivirals (systemic) intake within 2 weeks before screening,
- •Systemic or local corticosteroids (nasal route or inhalation) within 4 weeks before screening,
- •Antihistamines intake for allergy when treatment was started from less than 4 weeks before screening,
- •Vaccination against flu or COVID-19 within 6 months before screening,
- •Chronic decongestant use within 2 weeks before screening,
- •Bacterial lysates or immunostimulants (food supplements excluded) used for prevention of infection within the 6 months before the screening,
- •Prebiotics, probiotics used for prevention of infection within 6 months before the screening,
- •Pregnant/Lactating female or with sexual activity without hormonal contraception, intrauterine device or barrier methods.
结局指标
主要结局
Proportion of subjects without any upper respiratory tract infection (URTI) with nasal symptoms during the study.
时间窗: From the randomization up to Day 116
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.
次要结局
- Time to first Upper Respiratory Tract Infection with nasal symptoms during the study(From the randomization up to Day 116)
- Number of Upper Respiratory Tract Infections with nasal symptoms during the study(From the randomization up to Day 116)
- Number of Upper Respiratory Tract Infections complications(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(From the randomization up to Day 116)
- Number of school days lost due to Upper Respiratory Tract Infections and complications(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)