Acute CoughSIROPSEDALNCT07625683
Observational Study of SIROPSEDAL in Acute Cough
An observational study of Acute Cough and Upper Respiratory Tract Infection, run by Laboratoires Elerte at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Acute Cough, Upper Respiratory Tract Infection, Common Cold
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2026to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Cough, Upper Respiratory Tract Infection, Common Cold
- Keywords
- acute cough, cough, cough syrup, PMCF, Cough Symptom Score
- Medical subject headings
- Respiratory Tract Infections, Common Cold, Cough
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 2
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and Day 7 ±1 day or end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Elerte
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625683
- Sponsor's protocol ID
- 2025-A00950-49
- Acronym
- SIROPSEDAL
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Before-After Study in Children and Adults Treated for Acute Cough With SIROPSEDAL
- ClinicalTrials.gov ID
- NCT07625683
- Acronym / sponsor ID
- SIROPSEDAL / 2025-A00950-49
- Conditions
- Acute Cough, Upper Respiratory Tract Infection, Common Cold
- Keywords
- acute cough, cough, cough syrup, PMCF, Cough Symptom Score
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Laboratoires ElerteIndustry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Responder rate at Day 2
Time frame: 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.
9 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.
Time frame: Baseline to Day 2 and Day 7 ±1
Responder rate at Day 7
Time frame: Day 7 ±1
Change From Baseline in Total Cough Symptom Score (CSS)
Time frame: Day 2 and Day 7 ±1 day
Change From Baseline in Daytime Cough Symptom Score (CSS)
Time frame: Day 2 and Day 7 ±1 day
Change From Baseline in Nighttime Cough Symptom Score (CSS)
Time frame: Day 2 and Day 7 ±1 day
Percentage of Participants With Rhinitis
Time frame: Baseline and Day 7 ±1 day or end of study
Percentage of Participants With Sneezing
Time frame: Baseline and Day 7 ±1 day or end of study
Percentage of Participants With Colored Sputum
Time frame: Baseline and Day 7 ±1 day or end of study
Percentage of Participants With Fever
Time frame: Baseline and Day 7 ±1 day or end of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cough and Upper Respiratory Tract Infection, run by Laboratoires Elerte at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renaud URBINELLI (0756882093, etudes@clin-experts.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder rate at Day 2 (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.