Observational Study of SIROPSEDAL in Acute Cough (NCT07625683) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Observational Study of SIROPSEDAL in Acute Cough
France124 participantsStarted 2026-10-15
Plain-language summary
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.
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.