Observational Study of SIROPSEDAL in Acute Cough
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorLaboratoires Elerte
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
ACE inhibitor or sartan use.
Asthma or COPD.
Corticosteroids ongoing or within the previous 3 days.
Antibiotics ongoing or within the previous 3 days.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 2Secondary outcomes
1
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 ±12
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 ±13
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 day4
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 dayLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Multiples facilities Status unavailable Multiple Locations
France
FranceSponsors and contacts
Click on the lead sponsor to view all of their trials.
Laboratoires Elerte
Lead sponsor
Clin-Experts
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: