Impact of Adding Healsea® Isotonic Nasal Spray to Conventional Therapies for the Care of Children With Allergic Rhinitis Presenting With Symptoms of Acute Infectious Rhinitis: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- AUC (Area Under Curve) of the Wisconsin Upper Respiratory Symptoms Survey for Kids (WURSS-K) During the 10-day Treatment Period
研究概览
简要总结
Healsea® Children is a seawater-based nasal spray supplemented with a natural Symbiofilm® extract (0.02%) isolated from marine bacteria. Symbiofilm has antibiofilm activity against various bacterial pathogens involved in respiratory tract infections.Healsea® Children is indicated in the cleaning and moistening of nasal mucosa during common cold and rhinitis for children above 6 years.
This non interventional post-market clinical investigation aimed to confirm the benefit of Healsea® Children in real life setting in children with perennial allergy who are more prone to common cold.
详细描述
Healsea® Children is a seawater-based nasal spray supplemented with a natural Symbiofilm® extract (0.02%) isolated from marine bacteria. Symbiofilm® is an exopolymeric composition with emulsifying properties, in vitro antibiofilm activity and detachment properties against various bacterial pathogens involved in respiratory tract infections. Symbiofilm® has no bacteriostatic nor bactericidal activities. Healsea® Children is indicated in the cleaning and moistening of nasal mucosa during common cold and rhinitis.
The common cold is an acute viral infection of the upper respiratory tract, involving, to variable degrees, sneezing, nasal congestion and discharge (rhinorrhea), sore throat, cough, low-grade fever, headache, and malaise (1). It can be caused by members of several families of viruses; the most common are rhinoviruses. Acute viral rhinitis is generally self-limiting. In children where the illness is not self-limiting and extends beyond 7-10 days, many agree that a bacterial infection is likely (1). Bacterial over infections and progression to a chronic state are favoured by the formation of biofilms, which facilitate bacterial growth and persistence as well as reducing antibiotic efficacy (2-3).
Allergic diseases may play a particular role in promoting the respiratory infection recurrences (4). The physiological immune response is impaired in allergic subjects and allergic inflammation favours predisposition to respiratory infections. Subjects with allergic disorders may have functional defect of type 1 immune response that is relevant in fighting infections (5-6).
Allergic rhinitis (AR) may affect up to 40% of the paediatric population. Nasal symptoms are caused by exposure to an allergen to which a patient is sensitized.
AR is characterized by typical nasal symptoms and immunoglobulin E (IgE) -mediated inflammation. The allergic inflammatory process releases many cytokines and other proinflammatory proteins. Inflammation caused by nasal allergy leads to obstruction, fluid accumulation and acute disease. If these diseases are unsuccessfully treated, a chronic state of inflammation, obstruction, and infection develops that can cause mucosal damage and, ultimately, chronic disease (7).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female subjects ≥6 and ≤10-year-old
- •AsIgE (Allergy specific IgE) ≥ class 2 (RAST) or positive prick test for at least one perennial allergen
- •Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry
- •Patient presenting with fever ≥ 37.5 °C at screening
- •Symptoms of headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, sneezing with a total score ≤9 (according to a physician-rated symptom score; scale: 0 to 3 [0: no symptom to 3: severe intensity])
- •At least one of these symptoms: sore throat, runny nose or blocked nose (i.e., with a score ≥1)
- •Written consent obtained from parent/legal guardians
- •Written assent obtained from patient
排除标准
- •Known hypersensitivity/allergy to any component of the test device
- •Medical history 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
- •History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
- •Antibiotic intake within 2 weeks before screening
- •Systemic corticosteroids within 4 weeks before screening
- •Antihistamines intake for allergy when treatment was started from less than 4 weeks
- •Bacterial lysate intake within 6 months before screening
- •Chronic decongestant use
- •Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence symptom score at screening (NSAID, nasal decongestants, cough medicines)
结局指标
主要结局
AUC (Area Under Curve) of the Wisconsin Upper Respiratory Symptoms Survey for Kids (WURSS-K) During the 10-day Treatment Period
时间窗: Cumulative AUC of the WURSS score assessed from Day 1 to Day 10
The WURSS-K will be assessed once daily, from Day1 to Day10 (treatment period) WURSS-K is a 3-dimensional structure questionnaire specifically designed for children 4 to 10 years of age. It includes 6 items assessing symptoms (symptoms score: runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired), 7 items assessing functional impairments (quality of life score: think, sleep, breathe, talk, walk/climb stairs/exercise, go to school, play with friends), 1 item assessing global severity. All these items are scored from 0 (absent or no impairment) through 1 (a little bad), 2 (bad) and 3 (very bad). The AUC value of the WURSS-K during the 10 day- treatment period is comprised between 0 WURSS-K score\*day (no impairement) and 420 WURSS-K score \*day (maximal impairement)
次要结局
- Number of Days With Runny Nose(Number of days with runny nose during the 10-day treatment period and a follow-up of 20 days, up to 30 days)
- Number of Days With Stuffy Nose(Number of days with stuffy nose during the 10-day treatment period and a follow-up period of 20 days, up to 30 days)
- Number of Days With Sneezing(Number of days with sneezing during the 10-day treatment period and a follow-up of 20 days, up to 30 days)
- Number of Days With Sore Throat(Number of days with sore throat during the 10-day treatment period and a follow-up of 20 days, up to 30 days)
- Number of Days With Cough(Number of days with cough during the 10-day treatment period and a follow-up of 20 days, up to 30 days)
- Number of Days With "Feeling Tired"(Number of days with "feeling tired" during the 10-day treatment period and a follow-up of 20 days, up to 30 days)
- Respiratory Complication Requiring Antibiotic Prescription After the10-day Treatment Period(Number of subjects with respiratory complications during the 20-day follow-up period)
- Number of Participants With Use of Concomitant Treatments(During 10-day treatment period and a follow-up period of 20 days, up to 30 days)