Observational Study of SIROPSEDAL in Acute Cough (SIROPSEDAL)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Common Cold; Acute Cough; Upper Respiratory Tract Infection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 124

Contacts and Locations

• Study Contact: Name: Renaud URBINELLI; Phone Number: 0756882093; Email: etudes@clin-experts.fr

Study Locations

• France
  • Multiple Locations, France
    • Multiples facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rate at 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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)	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)	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)	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Laboratoires Elerte
• Collaborators: Clin-Experts

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: cough; PMCF; acute cough; cough syrup; Cough Symptom Score
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Respiration Disorders; Picornaviridae Infections; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiratory Tract Infections; Cough; Common Cold
• Other Study ID Numbers: 2025-A00950-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No