The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up Study

Pierre Fabre Medicament12 enrolled

Overview

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.

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

OBSERVATIONAL

Enrollment

Conditions

Sore-throat

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 6 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

Time frame: up to 3 days

Secondary Outcomes

Petit Drill Adherence

Average number of times Petit Drill is administered in each 24-hour period

Time frame: Day 1, day 2 and day 3

Parent's Satisfaction With Petit Drill

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.

Time frame: Day 3

Petit Drill Safety

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.

Time frame: 3 days