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Observational Study of SIROPSEDAL in Acute Cough (SIROPSEDAL)

2 juin 2026 mis à jour par: Laboratoires Elerte

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

124

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Renaud URBINELLI
Numéro de téléphone: 0756882093
E-mail: etudes@clin-experts.fr

Lieux d'étude

France
- - Multiple Locations, France
    - Multiples facilities

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Enfant
Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Responder rate at Day 2 Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
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. Délai: 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.	Baseline to Day 2 and Day 7 ±1
Responder rate at Day 7 Délai: Day 7 ±1	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) Délai: 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.	Day 2 and Day 7 ±1 day
Change From Baseline in Daytime Cough Symptom Score (CSS) Délai: 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.	Day 2 and Day 7 ±1 day
Change From Baseline in Nighttime Cough Symptom Score (CSS) Délai: 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	Day 2 and Day 7 ±1 day
Percentage of Participants With Rhinitis Délai: 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).	Baseline and Day 7 ±1 day or end of study
Percentage of Participants With Sneezing Délai: 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).	Baseline and Day 7 ±1 day or end of study
Percentage of Participants With Colored Sputum Délai: 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).	Baseline and Day 7 ±1 day or end of study
Percentage of Participants With Fever Délai: 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).	Baseline and Day 7 ±1 day or end of study

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Laboratoires Elerte

Collaborateurs

Clin-Experts

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 octobre 2026

Achèvement primaire (Estimé)

31 mai 2027

Achèvement de l'étude (Estimé)

30 septembre 2027

Dates d'inscription aux études

Première soumission

27 mai 2026

Première soumission répondant aux critères de contrôle qualité

2 juin 2026

Première publication (Réel)

4 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)