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Not yet recruiting NCT07625683

Observational Study of SIROPSEDAL in Acute Cough

— Observational Acute Cough Upper Respiratory Tract Infection Common Cold

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Cough, Upper Respiratory Tract Infection, Common Cold. Basic parameters: from 1 year · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • Responder rate at Day 2 [Time frame: Day 2]
Secondary outcome measures (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. [Time frame: Baseline to Day 2 and Day 7 ±1]
  • Responder rate at Day 7 [Time frame: Day 7 ±1]
  • Change From Baseline in Total Cough Symptom Score (CSS) [Time frame: Day 2 and Day 7 ±1 day]
  • Change From Baseline in Daytime Cough Symptom Score (CSS) [Time frame: Day 2 and Day 7 ±1 day]
  • Change From Baseline in Nighttime Cough Symptom Score (CSS) [Time frame: Day 2 and Day 7 ±1 day]
  • Percentage of Participants With Rhinitis [Time frame: Baseline and Day 7 ±1 day or end of study]
  • Percentage of Participants With Sneezing [Time frame: Baseline and Day 7 ±1 day or end of study]
  • Percentage of Participants With Colored Sputum [Time frame: Baseline and Day 7 ±1 day or end of study]
  • Percentage of Participants With Fever [Time frame: Baseline and Day 7 ±1 day or end of study]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Multiples facilities — Multiple Locations

Identifiers

NCT: NCT07625683 · 2025-A00950-49

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗