Clinical trial NCT06688370: The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up Study.
Official title: The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sore-throat
Cough
Keywords: dry cough
Petit Drill
throat irritation
sore throat
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
Collaborators: name: CEN Biotech
First posted: 2024-11-14
Enrollment: 245
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric population presented with acute dry cough

Brief summary: Demulcent or soothing substance is the currently recommended option to alleviate throat irritation associated to cough and sore throat in children under 6 years. The intended benefit to the patient of Petit Drill is to calm throat irritation (sore throat) associated to dry cough in infants starting at 6 months of age and in children up to 6 years of age. This intended benefit sustained by the properties of the formula is recognized and promoted by the World Health Organization, health authorities and current textbooks to have a positive impact on patient management for the targeted population (infant / child).

This study aims at assessing the effectiveness of the syrup in real-life context, in children presenting throat irritation to support the conclusion of clinical evaluation report.

Detailed description: Pediatric patients are recruited by pharmacist in community settings, who briefly present the clinical investigation to the parent who purchases Petit Drill for his/her child.

The pharmacist provides to interested parent the study inform note and transfer the parent's name and contact information to the clinical investigation centre. The parent is contacted to take part to the remote inclusion visit with a site investigator, scheduled within the day of Petit Drill delivery. Once consent has been signed, the investigator verifies eligibility criteria, then collects baseline data.

Follow-up lasts as long as the child receives the syrup, but no longer than 3 days and 3 nights. The parent completes daily questionnaires and record syrup intake in a secure mobile application for patient reported outcomes.

Eligibility criteria: Inclusion Criteria:

* Boys or girls, 6 months to 6 years of age;
* With one of his/her parents/legal guardian purchases Petit Drill in a participating pharmacy in accordance with recommendations for use (regarding age and type of cough);
* For infants between 6 months and 12 months of age - a confirmed prescription from a treating physician;
* With an acute cough lasting less than 48 hours
* With a score ≥ 3 at least for 3 of the 5 items of PCQ, (based on assessment of the night before inclusion);
* For whom child-minding will allow to respect the recommended daily doses of Petit Drill during the 3 day-treatment;
* With a parent/legal guardian having a smartphone allowing using the ePRO App. NursTrial®;
* With a parent/legal guardian able to understand and to complete to the questionnaires in timely manner;
* With parent(s)/legal guardian who provide their signed informed consent for the child's enrolment in the study.

Exclusion Criteria:

* Presenting with one of the following conditions: Chronic respiratory illness such as asthma, recurrent wheezing associated to viral infections and bronchitis or lower respiratory infections, such as bronchitis, bronchiolitis, and pneumonia or angina, otitis, or sinusitis or persistent cough lasting more than 3 weeks, whatever the etiology or gastrointestinal pathology, involving vomiting, nausea, or diarrhoea.
* With ongoing use of paracetamol, and/or homeopathic products against cough.
* Having had corticosteroid treatment, antibiotics, antihistaminic or any cough medication (such as, but not limited to, Phytoxil, Arkotoux) in the previous 15 days since inclusion.
* With a brother/sister already included in the present clinical investigation (If several children are eligible in the same household, only one will be enrolled at random).
* Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial.

Primary outcomes:
measure: Changes in sore throat severity at the end of the treatment
timeFrame: 3 days
Secondary outcomes:
measure: Description of study population
timeFrame: Day 0
measure: Description of study population
timeFrame: Day 0
measure: Description of study population
timeFrame: Day 0
measure: Description of study population
timeFrame: Day 0
measure: Changes in sore throat severity after 1 and 2 days under Petit Drill-treatment
timeFrame: Day 1, day 2
measure: Changes in nightly cough frequency, severity, bothersome for the child, and ability to sleep for child and parent(s) under Petit Drill-treatment
timeFrame: Day 1, day 2 and day 3
measure: Changes in daily cough severity under Petit Drill-treatment
timeFrame: Day 1, day 2 and day 3
measure: Changes in quality of life
timeFrame: Next morning of the last day of treatment (day 4 or earlier)
measure: Petit Drill posology
timeFrame: Day 1, day 2 ans day 3
measure: Parent's satisfaction with Petit Drill
timeFrame: Day 3
measure: Petit Drill safety
timeFrame: 3 days
Other outcomes:
measure: Rate of Petit Drill prescription
timeFrame: Day 0
Locations:
city: Dijon
country: France
facility: Cen Experimental
Study officials:
affiliation: Pharmacist
name: VINCENT ALQUIER
role: PRINCIPAL_INVESTIGATOR
affiliation: pediatrician pulmologist
name: GUY DUTAU
role: STUDY_CHAIR
References: