The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up Study.
- Conditions
- Sore-throatCough
- Registration Number
- NCT06688370
- Lead Sponsor
- Pierre Fabre Medicament
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 245
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in sore throat severity at the end of the treatment 3 days Percentage of children with a 3 point-decrease (minimal clinical significance) of the Pediatric Cough Questionnaire (PCQ) total score from baseline after up to 3 day-treatment with Petit Drill.
PCQ refers to a past night recall of 5 questions, each scored from 0 "Not at all" to 5 "Extremely" using a 6-point Likert scale.
PCQ Total score consists of the sum of each score and ranges from 0 to 25.
- Secondary Outcome Measures
Name Time Method Description of study population Day 0 home region (13 areas)
Changes in sore throat severity after 1 and 2 days under Petit Drill-treatment Day 1, day 2 Percentage of children with a 3 point-decrease of PCQ total score from baseline at 1 and 2 day-treatment with Petit Drill.
Changes in nightly cough frequency, severity, bothersome for the child, and ability to sleep for child and parent(s) under Petit Drill-treatment Day 1, day 2 and day 3 Global and score of the 5 items of PCQ (Q1: cough frequency, Q2: sleep disturbance of the child, Q3: sleep disturbance of the parent, Q4: cough severity, Q5: degree of bothersomeness to the child).
Changes in daily cough severity under Petit Drill-treatment Day 1, day 2 and day 3 Daily cough severity is measured using visual analogue scale (VAS) ranging from 0 (no cough) to 100 (worst cough) in response to "Yesterday, how was the cough of my child during the day?", measured VAS under Petit Drill-treatment.
Changes in quality of life Next morning of the last day of treatment (day 4 or earlier) Quality of life is measured using Parent-proxy Children's Acute Cough-Specific Questionnaire (PAC-QoL6) .
PAC-QoL6 consisted of 6 items utilizing a 7-point Likert-type rating scale (1 = all the time or very, very worried and concerned to 7 = none of the time or not worried and concerned). Items referred to a 24-hour recall. Higher PAC-QoL scores reflect better QoL with lower scores reflecting greater frequency and worries or concerns. The minimal clinical significance for the overall PAC-QoL6 questionnaire is therefore estimated to be 0.71-1.11.Petit Drill posology Day 1, day 2 ans day 3 Average number of times Petit Drill is administered in each 24-hour period
Parent's satisfaction with Petit Drill Day 3 Satisfaction is assessed using a study specific questionnaire. Responses measured using Likert scales. Not validated Questionnaire; 6 questions with different way to answers.
Petit Drill safety 3 days Number and type of adverse device effects and device deficiencies, coded ) coded according to the terms of the International Medical Device Regulators Forum.
Trial Locations
- Locations (1)
Cen Experimental
🇫🇷Dijon, France