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NCT Number: NCT07625683

Observational Study of SIROPSEDAL in Acute Cough

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.

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Key information

Conditions

Acute Cough Common Cold Cough Infections Pathological Conditions, Signs and Symptoms Picornaviridae Infections RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Upper Respiratory Tract Infection Virus Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiples facilities

Multiple Locations, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Responder rate at Day 2

    Time frame: 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.

Secondary outcomes

  1. 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.

    Time frame: Baseline to Day 2 and Day 7 ±1

    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.

  2. Responder rate at Day 7

    Time frame: Day 7 ±1

    Percentage of patients with a clinically meaningful reduction of at least 17 mm in cough intensity.

  3. Change From Baseline in Total Cough Symptom Score (CSS)

    Time frame: Day 2 and Day 7 ±1 day

    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.

  4. Change From Baseline in Daytime Cough Symptom Score (CSS)

    Time frame: Day 2 and Day 7 ±1 day

    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.

  5. Change From Baseline in Nighttime Cough Symptom Score (CSS)

    Time frame: Day 2 and Day 7 ±1 day

    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

  6. Percentage of Participants With Rhinitis

    Time frame: Baseline and Day 7 ±1 day or end of study

    Percentage of participants presenting rhinitis, assessed by investigator interview and clinical evaluation and recorded as present or absent (yes/no).

  7. Percentage of Participants With Sneezing

    Time frame: Baseline and Day 7 ±1 day or end of study

    Percentage of participants presenting sneezing, assessed by investigator interview and clinical evaluation and recorded as present or absent (yes/no).

  8. Percentage of Participants With Colored Sputum

    Time frame: Baseline and Day 7 ±1 day or end of study

    Percentage of participants presenting colored sputum, assessed by investigator interview and clinical evaluation and recorded as present or absent (yes/no).

  9. Percentage of Participants With Fever

    Time frame: Baseline and Day 7 ±1 day or end of study

    Percentage of participants presenting fever, assessed by investigator interview and clinical evaluation and recorded as present or absent (yes/no).

Study contacts

Contact information is provided by the study sponsor or research team.

Renaud URBINELLI

CONTACT

[email protected]

0756882093

Sponsors and collaborators

Lead sponsor

Laboratoires Elerte

Industry

Collaborators

  • Clin-Experts

Registry information

Official study title

Prospective Multicenter Before-After Study in Children and Adults Treated for Acute Cough With SIROPSEDAL

Acronym: SIROPSEDAL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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