Performance and Safety Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children With Upper Respiratory Tract Infection: a Prospective and Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 10
- 主要终点
- - Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-21 questionnaire in minor patients from 14 years old and adults.
研究概览
简要总结
The purpose of this study is to evaluate the tolerance, the performance and safety of this device, 22‰ Hypertonic seawater aerosol therapy solution in unidose container, to treat adult and peadiatric patients with of upper respiratory tract infection such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold.
The main questions it aims to answer are to assess if the 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation:
- improve nasal symptoms relief;
- improve sleep quality;
- improve mucus fluidizing;
- is safe and well tolerated.
The study is none comparative and will assess prospectively the symptomatic and functional benefits, the tolerance and the general safety of the medical device when used as an aerosol therapy solution, measured by change from baseline.
Treatments will be done at home and participants will be required to perform two on sites visits and to complete questionnaires and scales for 7 consecutive days from the treatment starting.
详细描述
Hypertonic seawater-based solution is a simple and well-known product. The performance of these solutions has been established in paediatric (infants, children), and in adult populations. The mode of action is based on the physical (mechanical) osmotic effect of the solution. Hypertonic saline induces an osmotic flow of water into the mucus layer, rehydrating the airway surface liquid and improving mucus clearance. Hypertonic saline also reduces viscosity and elasticity of mucus.
Hypertonic saline solution (seawater based or not) can be used for intranasal wash, or in association with a nebulization system as an aerosol therapy solution for inhalation. Inhalation via nebulization allows the formation of fine particles or liquid droplets in a gas.
In this study, 22‰ Hypertonic seawater solution, in unidose container, manufactured by Laboratoires Gilbert will be used as an aerosol therapy solution for inhalation in the treatment of URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold. The investigational medical device 22‰ Hypertonic seawater solution from Laboratoires Gilbert will be used in association with a nebulization system.
The purpose of this study is to evaluate the tolerance, the performance and safety of this device, 22‰ Hypertonic seawater aerosol therapy solution in unidose container, to treat adult and peadiatric patients with of upper respiratory tract infection such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold.
The main questions it aims to answer are to assess if the 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subject voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.
- •Minor subjects (7-17 years old) given informed assent to investigation participation in writing encompassing consent to data recording and verification procedures
- •Male and female subjects, aged from 2 years old;
- •Subject diagnosed with URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold based on the medical examination done by the doctor.
- •Subject willing to adhere to the requirements of the protocol, including availability for follow-up visits
- •Subject who agrees to no use decongestants, corticosteroids, antibiotics, allergen-specific immunotherapy, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), local nasal antiseptics, other nasal saline solutions or irrigations, nasal sprays, nasal creams or gels, systemic analgesics or antipyretics (except paracetamol if needed);
- •Subject who is able to comply with the study requirements, at the Investigator's appreciation.
- •For minor (<18) subjects, parents/guardians willing and able to sign written consent
- •Subject able and willing to use an internet-enabled device (computer, tablet, or smartphone) to complete study procedures (online questionnaires) and have regular access to a device with internet connectivity (personal or household device) for the duration of the study.
排除标准
- •Person with hypersensitivity to seawater
- •Subject who previously undergone bronchospasm
- •Children under 2 years of age
- •Pregnant and breastfeeding women
- •Onset of URTI symptoms > 48 hours
- •Subject with COVID or flu
- •Subject presenting alarm symptoms (periorbital oedema/erythema, displaced globe, double vision, ophthalmoplegia, reduced visual acuity, severe headache, frontal swelling, signs of sepsis, sign of meningitis, neurological signs) at the day of inclusion
- •Subject known to have allergy to the components of the masks that is used with the inhalation device;
- •Subject with asthma,
- •Subject presenting infection or pathology of the inferior respiratory tracts;
- •Subject with chronic nasal obstruction (polypes)
- •Subject who used any decongestants, corticosteroids, antibiotics or allergen-specific immunotherapy within 4 weeks prior to inclusion;
- •Subject who used any antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs) or local nasal antiseptics within 7 days prior to inclusion;
- •Subject who used any nasal saline solutions or irrigations, nasal sprays, nasal creams or gels, systemic analgesics or antipyretics within 24 hours prior to inclusion;
- •Subject with drug or alcohol abuse
- •Subjects who is deprived for their freedom by administrative or legal decision
- •Subject living in a social or sanitary establishment.
- •Subject being in an exclusion period for a previous study or with a current or recent (<3 months) participation in another investigational study involving a drug or combined device with drug.
- •Other condition preventing the subject to participate the study in the investigator's opinion: subject deemed unreliable or incapable of understanding and complying with the study assessment or unrealistic expectations of treatment results
研究组 & 干预措施
Patient treated with 22‰ Hypertonic seawater solution, used as aerosol therapy for inhalati
5mL of 22‰ Hypertonic seawater per treatments, 14 treatments on 7 consecutive days
干预措施: Treatment (22‰ Hypertonic seawater aerosol therapy solution) (Device)
结局指标
主要结局
- Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-21 questionnaire in minor patients from 14 years old and adults.
时间窗: From Day 1 to Day 3
Change in global WURSS-21 score as measured in the morning before treatment on Day 1 and Day 3 .
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-K questionnaire in minor patients from 4 to 13 years old.
时间窗: From Day 1 to Day 3
Change in global WURSS-K score as measured in the morning before treatment on Day 1 and Day 3.
次要结局
- Evaluate the overall safety of 22‰ Hypertonic seawater solution throughout the study.(From Day 0 to Day 8)
- Assess the immediate benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.(Day 1, Day 3, Day 5 and Day 7)
- Assess the sustained benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.(Day 1, Day 3, Day 5 and Day 7)
- Assess the proportion of patients that note a sustained benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief during the day.(Day 1, Day 3, Day 5 and Day 7)
- Evaluate the performance of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on the improvement of mucus fluidizing(Day 1, Day 3, Day 5, Day 7)
- Evaluate the overall patient's satisfaction.(Day 8)
- Evaluate the overall tolerance of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation.(From Day 1 to Day 7)
- Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-21 questionnaire in minor patients from 14 years old and adults.(Day 1, Day 2, Day 4, Day 5, Day 6, Day 7 and Day 8)
- Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-K questionnaire in minor patients from 4 to 13 years old.(Day 1, Day 2, Day 4, Day 5, Day 6, Day 7 and Day 8)
- Assess the immediate benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.(Day 1, Day 3, Day 5 and Day 7)
- Assess the proportion of patients that note an immediate benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.(Day 1, Day 3, Day 5 and Day 7)
- Assess the sustained benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.(Day 1, Day 3, Day 5 and Day 7)
- Assess the proportion of patients that note a sustained benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief during the day.(Day 1, Day 3, Day 5 and Day 7)
- Assess the benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation in improving sleep quality.(Day 1 before treatment, Day 2, Day 3, Day 5 and Day 7)
- Assess the proportion of patients reporting an improvement of sleep quality following evening treatment with the of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation.(Day 1 before treatment, Day 2, Day 3, Day 5 and Day 7)
- Evaluate the performance of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on the improvement of mucus fluidizing(Day 1, Day 3, Day 5, Day 7)
- Evaluate the overall patient's satisfaction.(Day 8)
- Evaluate the overall tolerance of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation.(From Day 1 to Day 7)
- Evaluate the overall safety of 22‰ Hypertonic seawater solution throughout the study.(From Day 0 to Day 8)
- Evaluate the device related complications rates throughout the study.(From Day 1 to Day 7)