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

NCT06688370 | Terminated Results DMC

• 2 other identifiers: NIS173792023-A01929-36
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Sore-throat; Cough

Keywords

dry cough; Petit Drill; throat irritation; sore throat

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 3 days

Secondary Outcomes (3)

• Petit Drill Adherence

  Day 1, day 2 and day 3

• Parent's Satisfaction With Petit Drill

  Day 3

• Petit Drill Safety

  3 days

Study Arms (1)

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.

Device: Petit Drill

Interventions

Petit Drill DEVICE

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.

Petit Drill

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric population presented with acute dry cough

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Pierre Fabre Medicament: lead
• CEN Biotech: collaborator

Study Sites (1)

Cen Experimental

Dijon, 21000, France

Location

MeSH Terms

Conditions

Pharyngitis; Cough

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Aurore Puglisi Mouton
• Organization: Pierre Fabre Médicament

aurore.puglisi.mouton@pierre-fabre.com

+335679463982

Study Officials

• VINCENT ALQUIER

  Pharmacist

  PRINCIPAL INVESTIGATOR

• GUY DUTAU

  pediatrician pulmologist

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: November 14, 2024
• Study Start: March 14, 2024
• Primary Completion: November 7, 2024
• Study Completion: November 7, 2024
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)