Observational Study of SIROPSEDAL in Acute Cough

NCT07625683 | Not Yet Recruiting

• 1 other identifier: 2025-A00950-49
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Cough; Upper Respiratory Tract Infection; Common Cold

Keywords

acute cough; cough; cough syrup; PMCF; Cough Symptom Score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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.

  Baseline to Day 2 and Day 7 ±1

• Responder rate at Day 7

  Day 7 ±1

• Change From Baseline in Total Cough Symptom Score (CSS)

  Day 2 and Day 7 ±1 day

• Change From Baseline in Daytime Cough Symptom Score (CSS)

  Day 2 and Day 7 ±1 day

• Change From Baseline in Nighttime Cough Symptom Score (CSS)

  Day 2 and Day 7 ±1 day

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Laboratoires Elerte: lead
• Clin-Experts: collaborator

Study Sites (1)

Multiples facilities

Multiple Locations, France

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Common Cold; Cough

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Renaud URBINELLI

CONTACT

0756882093; etudes@clin-experts.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

FR (1)