Advancing Diagnosis and Treatment of Pediatric Asthma

Sponsor
Luxembourg Institute of Health
Study ID
NCT07500246
Status
Recruiting
Apply to this trial

Conditions

  • Asthma
  • Asthma Childhood
  • Inhalation Spacers

Eligibility Criteria

Sex
ALL
Age
5 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 30, 2026
Start date
Jan 2, 2026
Status verified
Feb 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
208 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Inhaled corticosteroid administration in asthmatic children using AeroChamber Plus® Flow-Vu®
    Asthmatic children use AeroChamber Plus® Flow-Vu® to inhale their corticosteroid containing medication for 12 weeks. This inhaler is standard and does not have light indicators to monitor treatment administration.
  • Experimental: Inhaled corticosteroid administration in asthmatic children using the Whizz spacer.
    Asthmatic children use Whizz spacer to inhale their corticosteroid containing medication for 12 weeks. This inhaler has inhalation flow rate monitor with light indicators and is linked to a mobile application, to monitor treatment adherence and administration.
  • No Intervention: Non-asthmatic children
    Non-asthmatic children, male or female, aged 5-16 years old, who have a blood test foreseen in their medical routine follow up for a non-respiratory disease, are recruited for a single visit at baseline.

Primary Outcome Measure

Measurement of inhaled corticosteroid therapy adherence and comparison between the two spacers [ Time Frame: From enrolment to the end of the intervention at 12 weeks ]

Central Contacts

Find similar trials

Nationwide
Asthma trialsPulmonology trialsLung disease trials

Related Studies