Advancing Diagnosis and Treatment of Pediatric Asthma

Summary

Asthma is one of the most common chronic diseases in children, and treatment success often depends on proper inhaler use and consistent medication adherence. Exposure to allergens and pollutants can also impact treatment response and asthma control. Moreover, there is a growing need for non-invasive biomarkers to support better diagnosis and personalized care. The goal of this clinical trial is to investigate if a new digital inhaler can improve inhalation technique and treatment adherence in children aged 5 to 16 years old, with partly controlled or uncontrolled asthma requiring treatment with inhaled corticosteroids. The main questions it aims to answer are:

* Does the use of a digital inhaler improve adherence to inhaled corticosteroids and asthma control in children?
* Which biomarkers could support diagnosis and help predict treatment responses in children with asthma?
* How do environmental factors influence asthma control and treatment outcomes?

Researchers will compare adherence to inhaled corticosteroid therapy between children using a new digital inhaler (Whizz spacer) and those using a standard, non-digital inhaler (AeroChamber Plus® Flow-Vu®) to see if the digital inhaler improves treatment administration and asthma control. They will quantify inflammatory markers in biological samples from asthmatic children and children without respiratory disease, to find biomarkers linked to disease and treatment response.

Participants will:

* Use the Whizz spacer or the AeroChamber Plus® Flow-Vu® during 12 weeks for corticosteroid inhalation, and complete daily a study diary to follow treatment administration.
* Complete asthma control and quality of life questionnaires and have an evaluation of asthma control through GINA score at baseline, 6 and 12 weeks.
* Undergo spirometry tests and FENO measurements at baseline and 12 weeks.
* Give biological samples at baseline and 12 weeks.
* Collect children's bedroom dust samples at baseline.
* Wear a bracelet for 7 days at baseline and 12 weeks to monitor physical activity.

Conditions

• Asthma Childhood
• Asthma
• Inhalation Spacers

Interventions

DEVICE

Whizz spacer system

Whizz spacer is a new digital valved holding chamber that is intended to administer aerosolized medication from the metered dose inhaler to the patient. It allows monitoring of treatment administration through light indicators and a mobile application.

DEVICE

AeroChamber Plus® Flow-Vu®

AeroChamber Plus® Flow-Vu® is a standard valved holding chamber used to administer aerosolized medication from the metered dose inhaler to the patient.

Sponsors & Collaborators

• Luxembourg National Research Fund (FNR)

  collaborator UNKNOWN

• Centre Hospitalier du Luxembourg

  collaborator OTHER

• Meracle Health (Luxembourg) S.à.r.l

  collaborator INDUSTRY

• Luxembourg Institute of Health

  lead OTHER_GOV

Principal Investigators

• Christiane Hilger, PhD · Luxembourg Institute of Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-02

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• Luxembourg

Study Locations