Observational Study of SIROPSEDAL in Acute Cough (SIROPSEDAL)
2026年6月2日 更新者：Laboratoires Elerte
Prospective Multicenter Before-After Study in Children and Adults Treated for Acute Cough With SIROPSEDAL
This prospective, multicenter, observational post-market clinical follow-up study evaluates the performance and safety of SIROPSEDAL in children and adults with acute cough treated in routine clinical practice.
Patients prescribed SIROPSEDAL independently of study participation will be followed for 7 +/- 1 days using patient-reported outcomes including a cough visual analog scale and the Cough Symptom Score.
研究概览
详细说明
SIROPSEDAL is a CE-marked medical device syrup indicated for the relief of dry and productive cough in adults and children from 1 year of age.
This non-interventional multicenter French study is conducted under real-life conditions of use.
The primary objective is to evaluate the percentage of patients achieving a clinically meaningful reduction of at least 17 mm in cough intensity on a 0-100 mm visual analog scale between baseline and Day 2. Secondary outcomes include changes in cough intensity, Cough Symptom Score evolution, percentage of patients without cough, associated clinical signs, safety, device deficiencies and compliance.
研究类型
观察性的
注册 (估计的)
124
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：0756882093
- 邮箱：etudes@clin-experts.fr
学习地点
-
-
-
Multiple Locations、法国
- Multiples facilities
-
-
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 from 1 year of age presenting with acute cough for less than 10 days in French general practice, for whom SIROPSEDAL has been prescribed in routine care independently of study participation.
描述
Inclusion Criteria:
- Age greater than or equal to 1 year.
- Acute cough evolving for less than 10 days.
- Cough intensity VAS greater than 40/100.
- SIROPSEDAL prescribed independently from study participation.
- No hospitalization required.
- Written informed consent from the patient or from parent(s)/legal representative for minors, as applicable.
- Able to attend the Day 7 +/- 1 day visit or teleconsultation.
- Affiliated with or beneficiary of a health insurance system.
Exclusion Criteria:
- ACE inhibitor or sartan use.
- Asthma or COPD.
- Corticosteroids ongoing or within the previous 3 days.
- Antibiotics ongoing or within the previous 3 days.
- Antitussives ongoing or within the previous 3 days.
- Antihistamines ongoing or within the previous 3 days.
- Aerosol therapy ongoing or within the previous 3 days.
- Severe signs suggesting a causal disease requiring additional investigations according to the investigator.
- Severe signs requiring corticosteroids, aerosol therapy or centrally acting antitussive treatment according to the investigator.
- Any contraindication listed in the instructions for use.
- Patient under legal protection.
- Pregnancy.
- Intolerance, hypersensitivity or allergy to one or more product components.
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
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 |
|---|---|---|
|
Responder rate at Day 2
大体时间：Day 2
|
Percentage of patients with a clinically meaningful reduction of at least 17 mm in cough intensity between baseline and Day 2 on a 0-100 mm visual analog scale evaluating cough intensity during the previous 24 hours.
|
Day 2
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in cough intensity assessed using a 100-mm Visual Analog Scale (VAS). The scale ranges from 0 mm (no cough) to 100 mm (worst cough imaginable), with higher scores indicating greater cough intensity.
大体时间：Baseline to Day 2 and Day 7 ±1
|
Cough intensity will be assessed by the participant using a 100-mm Visual Analog Scale (VAS), ranging from 0 mm (no cough) to 100 mm (worst cough imaginable).
The outcome measure is the change from baseline to Day 2 and Day 7 ±1.
Higher scores indicate greater cough intensity.
|
Baseline to Day 2 and Day 7 ±1
|
|
Responder rate at Day 7
大体时间：Day 7 ±1
|
Percentage of patients with a clinically meaningful reduction of at least 17 mm in cough intensity.
|
Day 7 ±1
|
|
Change From Baseline in Total Cough Symptom Score (CSS)
大体时间：Day 2 and Day 7 ±1 day
|
Change from baseline in total cough frequency assessed using the Cough Symptom Score (CSS).
The total CSS score ranges from 0 to 10 and is calculated as the sum of the daytime and nighttime CSS components.
Higher scores indicate more frequent cough symptoms.
|
Day 2 and Day 7 ±1 day
|
|
Change From Baseline in Daytime Cough Symptom Score (CSS)
大体时间：Day 2 and Day 7 ±1 day
|
Change from baseline in daytime cough frequency assessed using the daytime component of the Cough Symptom Score (CSS).
The daytime CSS component is scored from 0 to 5, where 0 indicates no cough symptoms and 5 indicates the highest frequency of daytime cough symptoms.
Higher scores indicate more frequent cough symptoms.
|
Day 2 and Day 7 ±1 day
|
|
Change From Baseline in Nighttime Cough Symptom Score (CSS)
大体时间：Day 2 and Day 7 ±1 day
|
Change from baseline in nighttime cough frequency assessed using the nighttime component of the Cough Symptom Score (CSS).
The nighttime CSS component is scored from 0 to 5, where 0 indicates no cough symptoms and 5 indicates the highest frequency of nighttime cough symptoms.
Higher scores indicate more frequent cough symptoms
|
Day 2 and Day 7 ±1 day
|
|
Percentage of Participants With Rhinitis
大体时间：Baseline and Day 7 ±1 day or end of study
|
Percentage of participants presenting rhinitis, assessed by investigator interview and clinical evaluation and recorded as present or absent (yes/no).
|
Baseline and Day 7 ±1 day or end of study
|
|
Percentage of Participants With Sneezing
大体时间：Baseline and Day 7 ±1 day or end of study
|
Percentage of participants presenting sneezing, assessed by investigator interview and clinical evaluation and recorded as present or absent (yes/no).
|
Baseline and Day 7 ±1 day or end of study
|
|
Percentage of Participants With Colored Sputum
大体时间：Baseline and Day 7 ±1 day or end of study
|
Percentage of participants presenting colored sputum, assessed by investigator interview and clinical evaluation and recorded as present or absent (yes/no).
|
Baseline and Day 7 ±1 day or end of study
|
|
Percentage of Participants With Fever
大体时间：Baseline and Day 7 ±1 day or end of study
|
Percentage of participants presenting fever, assessed by investigator interview and clinical evaluation and recorded as present or absent (yes/no).
|
Baseline and Day 7 ±1 day or end of study
|
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
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5月31日
研究完成 (估计的)
2027年9月30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6月2日
首次发布 (实际的)
2026年6月4日
研究记录更新
最后更新发布 (实际的)
2026年6月4日
上次提交的符合 QC 标准的更新
2026年6月2日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 2025-A00950-49
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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