Observational Study of RHINOSEDAL in Acute Nasal Obstruction (RHINOSEDAL)
2026年5月27日 更新者：Laboratoires Elerte
Prospective Multicenter Before-After Study in Children and Adults Treated for Acute Nasal Obstruction With RHINOSEDAL
This prospective, multicenter, national, observational, non-interventional post-market clinical follow-up study evaluates the performance and safety of RHINOSEDAL in children and adults presenting with acute nasal obstruction associated with common cold, allergic or non-allergic rhinitis, or rhinosinusitis.
Patients prescribed RHINOSEDAL in routine care will be followed for 6 ±1 days using patient-reported outcome measures including the NOSE score.
研究概览
详细说明
RHINOSEDAL is a CE-marked class IIa medical device indicated in adults and children older than 2 years to relieve nasal congestion through an osmotic mechanism in cases of common cold, allergic or non-allergic rhinitis, and sinusitis.
This prospective observational study is conducted in real-life conditions of use in French general practice.
The decision to prescribe RHINOSEDAL is made before and independently from study participation.
Patients aged 8 years and older with acute nasal obstruction evolving for less than 48 hours and baseline NOSE score >40/100 will be included.
Patients will complete a self-assessment diary from Day 1 to Day 6 ±1.
The primary endpoint is the proportion of patients achieving a decrease greater than 24 mm in the NOSE score between baseline Day 0 and the Day 3 evening assessment.
Secondary endpoints include additional NOSE responder analyses, daily NOSE evolution, individual NOSE item evolution, social activity impairment, patient global assessment of effectiveness, associated signs, safety, device deficiencies, and compliance.
研究类型
观察性的
注册 (估计的)
126
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Renaud Urbinelli
- 电话号码：+33756882093
- 邮箱：etudes@clin-experts.fr
学习地点
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Multiple Locations、法国
- Multiples facilities
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Children and adults aged 8 years or older presenting with acute nasal obstruction associated with common cold, allergic or non-allergic rhinitis, or rhinosinusitis and treated in French general practice.
描述
Inclusion Criteria:
- Age 8 years or older.
- Acute nasal obstruction evolving for less than 48 hours associated with common cold, allergic or non-allergic rhinitis, or rhinosinusitis.
- Baseline NOSE score >40/100.
- No warning signs such as pus, unilateral obstruction, bleeding, or pain.
- RHINOSEDAL prescribed by the investigator.
- Written informed consent signed.
- Affiliated with a health insurance system.
Exclusion Criteria:
- Known anatomical cause of chronic nasal congestion.
- Corticosteroid use within the previous 2 days.
- NSAID use within the previous 2 days.
- Sympathomimetic use within the previous 2 days.
- Nasal decongestant or nasal irrigation within the previous 2 days.
- Antihistamines unless stable for more than 48 hours and maintained.
- Contraindication listed in the RHINOSEDAL instructions for use.
- Patient under legal protection.
- Pregnant or breastfeeding women.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Patients treated with RHINOSEDAL
Children and adults aged 8 years or older consulting a general practitioner for acute nasal obstruction associated with common cold, rhinitis, or rhinosinusitis and prescribed RHINOSEDAL in routine care.
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RHINOSEDAL is a ready-to-use hypertonic nasal spray containing natural sea water, tamarind extract and mallow extract.
It acts mechanically through osmotic decongestion and cleansing of the upper airways.
It is used according to the instructions for use and physician prescription.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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NOSE responder rate at Day 3
大体时间：Day 3 evening
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Percentage of patients with a reduction greater than 24 mm in the NOSE (Nasal Obstruction Symptom Evaluation) score between baseline Day 0 and the Day 3 evening assessment.
The NOSE questionnaire includes 5 items rated from 0 to 4 and normalized to a 0-100 score, where higher scores indicate more severe nasal obstruction symptoms.
For this study, the recall period was adapted from one month to the previous 24 hours.
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Day 3 evening
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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NOSE responder rate at Day 6 or end of study
大体时间：Day 6 ±1 day or early termination
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Percentage of patients with a reduction greater than 24 mm in the NOSE score between baseline Day 0 and Day 6 ±1 day or early termination.
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Day 6 ±1 day or early termination
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Daily evolution of total NOSE score
大体时间：Day 0 to Day 6 ±1 day or early termination
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Evolution of the total normalized NOSE score (0-100) assessed daily from inclusion through the patient diary until the final visit.
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Day 0 to Day 6 ±1 day or early termination
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Daily evolution of each NOSE questionnaire item
大体时间：Day 0 to Day 6 ±1 day or early termination
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Daily evolution of the five individual NOSE questionnaire items assessing nasal congestion severity, nasal blockage, trouble breathing through the nose, trouble sleeping, and inability to get enough air during exertion.
Each item is scored from 0 to 4.
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Day 0 to Day 6 ±1 day or early termination
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Daily evolution of social activity impairment
大体时间：Day 0 to Day 6 ±1 day or early termination
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Evolution of the intensity of discomfort in social activities measured on a 5-point numerical scale from 0 to 4, where higher scores indicate greater impairment.
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Day 0 to Day 6 ±1 day or early termination
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Patient global assessment of effectiveness
大体时间：End of study visit at Day 6 ±1 day or early termination
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Patient-rated overall effectiveness using a 5-point numerical scale: 0 = not effective at all; 1 = very slightly effective; 2 = slightly effective; 3 = fairly effective; 4 = very effective.
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End of study visit at Day 6 ±1 day or early termination
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Evolution of associated signs
大体时间：Day 0 to Day 6 ±1 day or early termination
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Change in associated clinical signs including nasal discharge, sneezing, fever, and other symptoms associated with upper respiratory tract conditions.
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Day 0 to Day 6 ±1 day or early termination
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Adverse events, serious adverse events, incidents and device deficiencies
大体时间：Inclusion to Day 6 ±1 day or early termination
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Number and description of adverse events, serious adverse events, incidents and device deficiencies reported during the study.
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Inclusion to Day 6 ±1 day or early termination
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Compliance / RHINOSEDAL use
大体时间：Day 0 to Day 6 ±1 day or early termination
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Compliance assessed using the patient diary, including number of daily instillations of RHINOSEDAL.
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Day 0 to Day 6 ±1 day or early termination
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Pascal DEMOLY, MD, PhD、University hospital of Montpellier, FRANCE
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月15日
初级完成 (估计的)
2027年10月31日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年5月27日
首先提交符合 QC 标准的
2026年5月27日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年6月2日
上次提交的符合 QC 标准的更新
2026年5月27日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2025-A02041-48
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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