Due to difficulty in recruiting patients, the Sponsor decided to prematurely stop the study

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.

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.

Pediatric population presented with acute dry cough

Full Analysis Set (FAS) population: the analysis population consists of patients who were included in this clinical investigation after fulfilling all eligibility criteria.

Adverse events were collected over days D1, D2, D3, D4

The main limitation of this study is the very small number of patients included and analyzed (12 patients in the safety analysis; 7 in performance), because the study had been stopped prematurely due to major recruitment difficulties.