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| Name | Class |
|---|---|
| Clin-Experts | INDUSTRY |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renaud URBINELLI | Contact | 0756882093 | etudes@clin-experts.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiples facilities | Multiple Locations | France |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D003139 | Common Cold |
| D003371 | Cough |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| 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. | 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. | 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. | Day 2 and Day 7 ±1 day |
| Change From Baseline in Nighttime Cough Symptom Score (CSS) | 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 | 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 | 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 | 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 | 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 |
| D014777 |
| Virus Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |