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Observational Study of SIROPSEDAL in Acute Cough (SIROPSEDAL)

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

124

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Multiple Locations, Frankrig
        • Multiples facilities

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Responder rate at Day 2
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Laboratoires Elerte

Samarbejdspartnere

Clin-Experts

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. oktober 2026

Primær færdiggørelse (Anslået)

31. maj 2027

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-A00950-49

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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