Acute Cough, Common Cold, Upper Respiratory Tract Infection
Conditions
Keywords
acute cough, cough, cough syrup, PMCF, Cough Symptom Score
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Laboratoires Elerte
Clin-Experts
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate at Day 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Responder rate at Day 7 | Day 7 ±1 | Percentage of patients with a clinically meaningful reduction of at least 17 mm in cough intensity. |
| Change From Baseline in Total Cough Symptom Score (CSS) | 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. |
| Change From Baseline in Daytime Cough Symptom Score (CSS) | 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. |
| Change From Baseline in Nighttime Cough Symptom Score (CSS) | 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 |
| Percentage of Participants With Rhinitis | 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). |
| Percentage of Participants With Sneezing | 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). |
| Percentage of Participants With Colored Sputum | 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). |
| Percentage of Participants With Fever | 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). |
Countries
France
Contacts
CONTACTRenaud URBINELLI
Outcome results
None listed