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Observational Study of SIROPSEDAL in Acute Cough (SIROPSEDAL)

2 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

124

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Renaud URBINELLI
Telefoonnummer: 0756882093
E-mail: etudes@clin-experts.fr

Studie Locaties

Frankrijk
- - Multiple Locations, Frankrijk
    - Multiples facilities

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Kind
Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Responder rate at Day 2 Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
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. Tijdsspanne: 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 Tijdsspanne: 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) Tijdsspanne: 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) Tijdsspanne: 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) Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Laboratoires Elerte

Medewerkers

Clin-Experts

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 oktober 2026

Primaire voltooiing (Geschat)

31 mei 2027

Studie voltooiing (Geschat)

30 september 2027

Studieregistratiedata

Eerst ingediend

27 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)