Prospective Multicenter Before-After Study in Children and Adults Treated for Acute Cough With SIROPSEDAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 1 year.
- •Acute cough evolving for less than 10 days.
- •Cough intensity VAS greater than 40/
- •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.
排除标准
- •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.