Evaluation of Treatments for Acute Viral Rhinitis, Rhinosinusitis, and Rhinopharyngitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Tolerance
研究概览
简要总结
The objective of this study is to conduct post-marketing clinical follow-up of four products: NS, NHE, NHG, and PIR. This follow-up will consist of collecting clinical data in real-life conditions to confirm the tolerance, safety, and efficacy of medical devices used in the treatment of acute viral rhinitis, rhinosinusitis, and rhinopharyngitis, while also assessing the benefit/risk ratio of the products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute viral rhinitis or acute rhinosinusitis or viral rhinopharyngitis (sneezing, rhinorrhea, nasal obstruction, cough secondary to posterior rhinorrhea, sore throat) that began less than 72 hours prior to the inclusion visit, in the investigator's judgment,
- •Effective contraception for female patients of childbearing age.
- •Cooperation and sufficient understanding to comply with the requirements of the trial.
- •Acceptance of registration in the SI-RIPH VRB file.
- •Having received informed information and agreeing to give written consent.
- •Affiliated with the French Social Security system.
排除标准
- •Hypersensitivity/history of allergy to any of the product's components,
- •Complicated rhinitis, rhinosinusitis, or rhinopharyngitis (acute bacterial sinusitis, acute otitis media, acute bronchitis, or pneumonia) or severe cough that is poorly tolerated,
- •Chronic rhinosinusitis,
- •Allergic rhinosinusitis,
- •Other ongoing treatments for acute rhinitis (local treatment, antitussives, antibiotics, antiretrovirals, corticosteroids, etc.),
- •Positive antigen test for influenza A/B or COVID-19 and infection requiring etiological treatment according to the recommendations,
- •Bacterial rhinopharyngitis with positive TROD test
- •Comorbidities or health conditions deemed incompatible with the trial by the investigator,
- •Recent ENT surgery (<6 months),
- •ENT pathology such as nasal septum deviation or other causes of nasal obstruction,
- •Pulmonary pathology (COPD, asthma, etc.),
- •Immunosuppression (as reported by the patient),
- •Pregnant or breastfeeding women,
- •Currently participating in another clinical trial, or in the exclusion period, or having received total compensation of more than €6,000 in the 12 months prior to the start of the trial,
- •Benefiting from legal protection measures (guardianship, trusteeship, deprivation of liberty, judicial protection).
研究组 & 干预措施
PIR
Patients included in the "PIR" arm will receive the medical device of the same name.
干预措施: PIR (Device)
NS
Patients included in the "NS" arm will receive the medical device of the same name.
干预措施: NS (Device)
NHE
Patients included in the "NHE" arm will receive the medical device of the same name.
干预措施: NHE (Device)
NHG
Patients included in the "NHG" arm will receive the medical device of the same name.
干预措施: NHG (Device)
结局指标
主要结局
Tolerance
时间窗: From visit 1 (day 1) to visit 2 (day 15)
Collection of adverse events (AEs) during the period of use of PIR, NS, NHE, and NHG products in an electronic daily recording book.
次要结局
- Efficiency(From visit 1 (day 1) to the last day of use of the study product (day 14))
- Quality of life impact(From visite 1 (day 1) to visit 2 (day 15))
- Device defect(From visit 1 (day 1) to visit 2 (day 15))