Trial Outcomes & Findings for The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up Study (NCT NCT06688370)

Last Updated: 2025-12-23

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

12 participants

Primary outcome timeframe

up to 3 days

Results posted on

2025-12-23

Participant Flow

Participant milestones

Participant milestones
Measure	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. Petit Drill: 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.
Overall Study STARTED	12
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Petit Drill: 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.
Overall Study Discontinued the treatment	1
Overall Study Prohibited treatment taken	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Petit Drill n=12 Participants Participants who received treatment with the syrup (at least once) as long as necessary from D1 to D3, according to parent's judgement. Petit Drill: 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.
Age, Continuous	3.1 year STANDARD_DEVIATION 1.9 • n=12 Participants
Sex: Female, Male Female	7 Participants n=12 Participants
Sex: Female, Male Male	5 Participants n=12 Participants
Rank of sibling Single child	3 Participants n=12 Participants
Rank of sibling First	4 Participants n=12 Participants
Rank of sibling Second	2 Participants n=12 Participants
Rank of sibling Third	2 Participants n=12 Participants
Rank of sibling Fourth	1 Participants n=12 Participants
Description of study population (home region) Bourgogne Franche-Comté	1 Participants n=12 Participants
Description of study population (home region) Centre-Val de Loire	1 Participants n=12 Participants
Description of study population (home region) Grand Est	3 Participants n=12 Participants
Description of study population (home region) Hauts-de-France	2 Participants n=12 Participants
Description of study population (home region) Nouvelle-Aquitaine	3 Participants n=12 Participants
Description of study population (home region) Occitanie	2 Participants n=12 Participants

PRIMARY outcome

Timeframe: up to 3 days

Population: Performance population which consists of all patients from the safety population without any major deviation from the protocol and for whom at least one evaluation of the primary outcome is available after treatment initiation (baseline and last assessment) and whose parent(s) or legal guardian did not withdraw their consent at any time. Due to the premature study discontinuation, analysis initially planned was not done, and all study outcomes were analyzed using descriptive statistics.

Outcome measures

Outcome measures
Measure	Petit Drill n=7 Participants Participants who received treatment with the syrup (at least once) as long as necessary from D1 to D3, according to parent's judgement. Petit Drill: 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.
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	7 Participants

SECONDARY outcome

Timeframe: Day 1, day 2 and day 3

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

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

Outcome measures

Outcome measures
Measure	Petit Drill n=12 Participants Participants who received treatment with the syrup (at least once) as long as necessary from D1 to D3, according to parent's judgement. Petit Drill: 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 Adherence At least 1 day with 3 doses	6 Participants
Petit Drill Adherence 1 day with 4 doses	1 Participants
Petit Drill Adherence less than 3 doses received at all days	5 Participants

SECONDARY outcome

Timeframe: Day 3

Population: Full Analysis Set (FAS) population: the analysis population consists of patients who were included in this clinical investigation after fulfilling all eligibility criteria. Of note, parents were not considered enrolled but did contribute to this assessment.

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.

Outcome measures

Outcome measures
Measure	Petit Drill n=9 Participants Participants who received treatment with the syrup (at least once) as long as necessary from D1 to D3, according to parent's judgement. Petit Drill: 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.
Parent's Satisfaction With Petit Drill Satisfaction with information from IFU to use treatment: very satisfied	3 Participants
Parent's Satisfaction With Petit Drill Ease of syrup use: yes generally	2 Participants
Parent's Satisfaction With Petit Drill Ease of syrup use: yes definitely	7 Participants
Parent's Satisfaction With Petit Drill Ease of syrup use: no	0 Participants
Parent's Satisfaction With Petit Drill Feeling that the child enjoyed the syrup taste: yes generally	2 Participants
Parent's Satisfaction With Petit Drill Feeling that the child enjoyed the syrup taste: yes definitely	7 Participants
Parent's Satisfaction With Petit Drill Feeling that the child enjoyed the syrup taste: no	0 Participants
Parent's Satisfaction With Petit Drill Quality of therapeutic management: excellent	2 Participants
Parent's Satisfaction With Petit Drill Quality of therapeutic management: good	5 Participants
Parent's Satisfaction With Petit Drill Quality of therapeutic management: fair	1 Participants
Parent's Satisfaction With Petit Drill Quality of therapeutic management: poor	1 Participants
Parent's Satisfaction With Petit Drill Response to the child's needs: almost all were met	2 Participants
Parent's Satisfaction With Petit Drill Response to the child's needs: most were met	4 Participants
Parent's Satisfaction With Petit Drill Response to the child's needs: only few were met	3 Participants
Parent's Satisfaction With Petit Drill Response to the child's needs: none were met	0 Participants
Parent's Satisfaction With Petit Drill Willingness to recommend the syrup: yes generally	2 Participants
Parent's Satisfaction With Petit Drill Willingness to recommend the syrup: yes definitely	5 Participants
Parent's Satisfaction With Petit Drill Willingness to recommend the syrup: no	2 Participants
Parent's Satisfaction With Petit Drill Satisfaction with information from Instruction For Use (IFU) to use treatment: quite dissatisfied	0 Participants
Parent's Satisfaction With Petit Drill Satisfaction with information from IFU to use treatment: indifferent or mildly dissatisfied	0 Participants
Parent's Satisfaction With Petit Drill Satisfaction with information from IFU to use treatment: mostly satisfied	6 Participants

SECONDARY outcome

Timeframe: 3 days

Population: Safety population: the safety population will include all patients from the FAS population who used Petit Drill at least once.

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.

Outcome measures

Outcome measures
Measure	Petit Drill n=12 Participants Participants who received treatment with the syrup (at least once) as long as necessary from D1 to D3, according to parent's judgement. Petit Drill: 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 Safety Adverse events	4 Participants
Petit Drill Safety Serious adverse events	0 Participants
Petit Drill Safety Adverse device effect related to procedures	1 Participants
Petit Drill Safety Adverse device effect related to device deficiency	1 Participants
Petit Drill Safety Adverse event leading to permanent discontinuation	1 Participants

Adverse Events

Petit Drill

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Petit Drill n=12 participants at risk Treatment with the syrup for as long as necessary from D1 to D3, according to parent's judgement. Petit Drill: 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.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 • Adverse events were collected over days D1, D2, D3, D4
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.3% 1/12 • Adverse events were collected over days D1, D2, D3, D4
Respiratory, thoracic and mediastinal disorders Tonsilitis	8.3% 1/12 • Adverse events were collected over days D1, D2, D3, D4
Injury, poisoning and procedural complications Underdose	8.3% 1/12 • Adverse events were collected over days D1, D2, D3, D4
Injury, poisoning and procedural complications Device use error	8.3% 1/12 • Adverse events were collected over days D1, D2, D3, D4
Gastrointestinal disorders Vomiting	8.3% 1/12 • Adverse events were collected over days D1, D2, D3, D4
General disorders Fatigue	8.3% 1/12 • Adverse events were collected over days D1, D2, D3, D4

Additional Information

Aurore Puglisi Mouton

Pierre Fabre Médicament

Phone: +335679463982

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place