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Observational Study of SIROPSEDAL in Acute Cough (SIROPSEDAL)

2 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

124

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Renaud URBINELLI
Número de telefone: 0756882093
E-mail: etudes@clin-experts.fr

Locais de estudo

França
- - Multiple Locations, França
    - Multiples facilities

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Filho
Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Responder rate at Day 2 Prazo: 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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
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. Prazo: 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 Prazo: 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) Prazo: 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) Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Laboratoires Elerte

Colaboradores

Clin-Experts

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de outubro de 2026

Conclusão Primária (Estimado)

31 de maio de 2027

Conclusão do estudo (Estimado)

30 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

27 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de junho de 2026

Primeira postagem (Real)

4 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)