The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up Study (Touxpetit)
The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up.
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 aimed at assessing the performance of the syrup in real-life context, in children presenting throat irritation associated with dry cough to support the conclusion of clinical evaluation report.
Study Overview
Detailed Description
Pediatric patients were recruited by pharmacist in community settings, who briefly presented the clinical investigation to the parent who purchases Petit Drill for his/her child.
The pharmacist provided the interested parent with the study information note and transferred the parent's name and contact details to the clinical investigation centre. The parent was then contacted to take part in the remote inclusion visit with a site investigator, scheduled on the same day of Petit Drill delivery. During the inclusion visit, once consent has been signed, the investigator verified eligibility criteria, and collected baseline data.
The follow-up periods lasted as long as the child received the syrup, but it should not exceed 3 days and 3 nights. The parent completed daily questionnaires and recorded the child's syrup intake in a secure mobile application designed for patient reported outcomes (PROs).
Of note, due to the premature discontinuation of the study, all statistical analyses initially planned in the Statistical Analysis Plan (SAP) were not conducted. All study outcomes were analyzed using descriptive statistics. Therefore, results presented hereafter are limited to few study outcomes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Dijon, France, 21000
- CEN Expérimental
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 dry 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Petit Drill
Participants who received treatment with the syrup (at least once) as long as necessary from D1 to D3, according to parent's judgement.
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Day 1: 2-4 doses, including one of the daily doses taken at bedtime.
Days 2 and 3: 3 to 4 doses, including one of the daily doses taken at bedtime.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in the Pediatric Cough Questionnaire (PCQ) Total Score - Percentage of Children With a 3-point Decrease From Baseline After up to 3-day Treatment With Petit Drill
Time Frame: up to 3 days
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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. |
up to 3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Petit Drill Adherence
Time Frame: Day 1, day 2 and day 3
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Average number of times Petit Drill is administered in each 24-hour period
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Day 1, day 2 and day 3
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Parent's Satisfaction With Petit Drill
Time Frame: Day 3
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Satisfaction is assessed using a study specific questionnaire. Responses measured using Likert scales. Not validated Questionnaire; 6 questions with different way to answers. Of note, parents were not considered enrolled but did contribute to this assessment. |
Day 3
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Petit Drill Safety
Time Frame: 3 days
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Number of participants with adverse events and adverse device effects coded by using the System Organ Class (SOC) and Preferred Term (PT) of the version 24.1 of the Medical Dictionary for Regulatory Activities (MedDRA) dictionary.
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3 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of Petit Drill prescription
Time Frame: Day 0
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The percentage of children receiving Petit Drill with or without physician prescription depending on age groups: from 6 months to 12 months old and from 13 months old to 6 years of age.
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Day 0
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: VINCENT ALQUIER, Pharmacist
- Study Chair: GUY DUTAU, pediatrician pulmologist
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS17379
- 2023-A01929-36 (Registry Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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