Observational Study of SIROPSEDAL in Acute Cough

N/ANot Yet RecruitingNCT07625683

Laboratoires Elerte124 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

124

Conditions

Acute Cough Upper Respiratory Tract Infection Common Cold

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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.

Locations (1)

Multiples facilities

Multiple Locations, France

Outcomes

Primary Outcomes

Responder rate at 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.

Time frame: Day 2

Secondary Outcomes

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.

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.

Time frame: Baseline to Day 2 and Day 7 ±1

Responder rate at Day 7

Percentage of patients with a clinically meaningful reduction of at least 17 mm in cough intensity.

Time frame: Day 7 ±1

Change From Baseline in Total Cough Symptom Score (CSS)

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.

Time frame: Day 2 and Day 7 ±1 day

Change From Baseline in Daytime Cough Symptom Score (CSS)

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.

Time frame: Day 2 and Day 7 ±1 day

Central Contacts

Renaud URBINELLI

CONTACT

0756882093 etudes@clin-experts.fr

Data from ClinicalTrials.gov

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