Cough, Sore-throat
Conditions
Keywords
dry cough, Petit Drill, throat irritation, sore throat
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.
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.
Interventions
DEVICEPetit 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.
Sponsors
CEN Biotech
Pierre Fabre Medicament
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to 3 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Petit Drill Adherence | Day 1, day 2 and day 3 | Average number of times Petit Drill is administered in each 24-hour period |
| Parent's Satisfaction With Petit Drill | Day 3 | 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. |
| Petit Drill Safety | 3 days | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discontinued the treatment | 1 |
| Overall Study | Prohibited treatment taken | 4 |
Baseline characteristics
| Characteristic | Petit Drill | — |
|---|---|---|
| Age, Continuous | 3.1 year STANDARD_DEVIATION 1.9 | — |
| Description of study population (home region) Bourgogne Franche-Comté | 1 Participants | — |
| Description of study population (home region) Centre-Val de Loire | 1 Participants | — |
| Description of study population (home region) Grand Est | 3 Participants | — |
| Description of study population (home region) Hauts-de-France | 2 Participants | — |
| Description of study population (home region) Nouvelle-Aquitaine | 3 Participants | — |
| Description of study population (home region) Occitanie | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Rank of sibling First | 4 Participants | — |
| Rank of sibling Fourth | 1 Participants | — |
| Rank of sibling Second | 2 Participants | — |
| Rank of sibling Single child | 3 Participants | — |
| Rank of sibling Third | 2 Participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 4 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Petit Drill | 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
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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Petit Drill | Parent's Satisfaction With Petit Drill | Quality of therapeutic management: excellent | 2 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Quality of therapeutic management: good | 5 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Quality of therapeutic management: fair | 1 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Quality of therapeutic management: poor | 1 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Response to the child's needs: only few were met | 3 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Response to the child's needs: none were met | 0 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Willingness to recommend the syrup: yes generally | 2 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Willingness to recommend the syrup: yes definitely | 5 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Willingness to recommend the syrup: no | 2 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Satisfaction with information from Instruction For Use (IFU) to use treatment: quite dissatisfied | 0 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Satisfaction with information from IFU to use treatment: indifferent or mildly dissatisfied | 0 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Satisfaction with information from IFU to use treatment: mostly satisfied | 6 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Satisfaction with information from IFU to use treatment: very satisfied | 3 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Ease of syrup use: yes generally | 2 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Ease of syrup use: yes definitely | 7 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Ease of syrup use: no | 0 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Feeling that the child enjoyed the syrup taste: yes generally | 2 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Feeling that the child enjoyed the syrup taste: yes definitely | 7 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Feeling that the child enjoyed the syrup taste: no | 0 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Response to the child's needs: almost all were met | 2 Participants |
| Petit Drill | Parent's Satisfaction With Petit Drill | Response to the child's needs: most were met | 4 Participants |
Secondary
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
Population: Full Analysis Set (FAS) population: the analysis population consists of patients who were included in this clinical investigation after fulfilling all eligibility criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Petit Drill | Petit Drill Adherence | At least 1 day with 3 doses | 6 Participants |
| Petit Drill | Petit Drill Adherence | 1 day with 4 doses | 1 Participants |
| Petit Drill | Petit Drill Adherence | less than 3 doses received at all days | 5 Participants |
Secondary
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
Population: Safety population: the safety population will include all patients from the FAS population who used Petit Drill at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Petit Drill | Petit Drill Safety | Adverse events | 4 Participants |
| Petit Drill | Petit Drill Safety | Serious adverse events | 0 Participants |
| Petit Drill | Petit Drill Safety | Adverse device effect related to procedures | 1 Participants |
| Petit Drill | Petit Drill Safety | Adverse device effect related to device deficiency | 1 Participants |
| Petit Drill | Petit Drill Safety | Adverse event leading to permanent discontinuation | 1 Participants |