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Observational Study of SIROPSEDAL in Acute Cough (SIROPSEDAL)

2026년 6월 2일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

124

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Renaud URBINELLI
전화번호: 0756882093
이메일: etudes@clin-experts.fr

연구 장소

프랑스
- - Multiple Locations, 프랑스
    - Multiples facilities

참여기준

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자격 기준

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아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

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주요 결과 측정

결과 측정	측정값 설명	기간
Responder rate at Day 2 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
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. 기간: 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 기간: 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) 기간: 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) 기간: 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) 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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

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스폰서

Laboratoires Elerte

협력자

Clin-Experts

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 15일

기본 완료 (추정된)

2027년 5월 31일

연구 완료 (추정된)

2027년 9월 30일

연구 등록 날짜

최초 제출

2026년 5월 27일

QC 기준을 충족하는 최초 제출

2026년 6월 2일

처음 게시됨 (실제)

2026년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)