The performance and safety of Petit Drill in the French paediatric population: a post-marketed clinical follow-up

The performance and safety of Petit Drill in the French paediatric population: a post-marketed clinical follow-up.

How is the study conducted?

This was an observational study conducted in France. An observational study looks at how the product tested works in everyday life. This type of study does not have strict conditions to be included like in clinical interventional trials, as the aim is to reflect real life. Since Petit Drill® is delivered in pharmacies, pharmacists managed the people contact. Pharmacists also checked the criteria to enter in the study. One clinical centre based in France managed the study.
People were treated according to routine practice. No additional intervention or visit was required.
Parent or legal guardian completed questionnaires via a mobile application.
Participants were treated for 3 days.

Who can take part in the trial ?

The study took place in France.

The following people could participate in the study:

Boys or girls, 6 months to 6 years of age
With Petit Drill® bought in a pharmacy
With acute dry cough lasting < 48 hours
With a score ≥ 3 at least for 3 of the 5 items of Pediatric Cough Questionnaire (PCQ)*
With Petit Drill® used at the usual dose during the 3 days of treatment

* PCQ is a questionnaire assessing how the nightly cough impact child and parents’ life.

What are the objectives of the trial and how are they evaluated ?

The main objective of this study was to describe the performance of Petit Drill® syrup.

The secondary objectives were:

To describe the characteristics of the people using Petit Drill®
To describe the benefit of Petit Drill®regarding nighly cough, cough severity, and quality of life
To describe if Petit Drill® was well tolerated

What is the study Medication ?

Children took Petit Drill® syrup bought in pharmacy. The dose received was the usual recommended one.
Therefore, during the study, the doses taken were: 2-4 doses on the first day, then 3 to 4 doses on the second day and the third day.

More information

This study has been conducted according to ethical considerations and has followed the rules for conducting such study. The study started only after it was approved. People provided their consent to participate in the study.