Observational Study of SIROPSEDAL in Acute Cough
Starting soon
Conditions studied: Acute Cough, Upper Respiratory Tract Infection, Common Cold
In brief
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.
Key facts
- Study ID
- NCT07625683
- Run by
- Laboratoires Elerte
- People needed
- 124
- Starts
- 2026-10-15
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2026-06-04
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Multiples facilities — Multiple Locations, France
Full record on ClinicalTrials.gov
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