Advancing Diagnosis and Treatment of Pediatric Asthma
Asthma Childhood · Asthma · Inhalation Spacers
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 5 years - 16 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 208 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Patient aged between 5-16 years, male or female
- Physician diagnosis of asthma requiring a controller treatment with ICS or ICS/Long-acting beta-agonists (LABA) via MDI
- Partly controlled or uncontrolled asthma based on GINA criteria and definitions
- Informed consent signed by legally authorized representatives (LAR) and assent from young patient (only applicable for children ≥ 10 years)
Exclusion Criteria:
- Patients with severe asthma exacerbation treated with systemic corticosteroids within the last 2 weeks or patients with active respiratory tract infection
- Diagnosis of underlying chronic lung disease other than asthma (e.g., BPCO/cystic fibrosis etc.)
- Severe asthma based on GINA definitions
- Severe underlying disorders ((severe congenital heart disease, oncologic patients) (non-exhaustive list, left to the evaluation of the PI))
- Immune deficiency or under immunosuppressive treatments
- In receipt of immunotherapy (only for participants in Luxembourg donating samples for biomarker research)
- Patients with neurological diseases / impaired cognitive disorder
- Siblings of patients already included in the study
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
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.
Device: AeroChamber Plus® Flow-Vu®
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.
Device: Whizz spacer system
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.
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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
Adherence rate will be measured by the entries in the study booklet as well as weighing the medication canisters at baseline, 6 weeks and at 12 weeks. Researchers expect to determine if light indicators and digital reminders on the Whizz spacer led to increased adherence to treatment and thus to a better clinical outcome in asthmatic children, as compared to a standard spacer.
Secondary measures
Assessment of asthma control
Time frame: At baseline and at the end of the intervention (12 weeks)
Asthma control will be assessed by clinical evaluation, objective lung function tests and patient questionnaires. Researchers want to compare asthma control in children using the Whizz spacer and the standard spacer.
Quantification of inflammatory markers and deep immunophenotyping of circulating immune cells to identify non-invasive biomarkers and immune signatures
Time frame: At baseline and at the end of the intervention (12 weeks)
Inflammatory markers will be quantified in biological samples obtained from asthmatic children. Researchers expect to determine biomarkers and immune signatures associated with response to inhaled corticosteroid treatment and to different asthma endotypes. These biomarkers could be used for asthma diagnosis and to predict treatment response and asthma exacerbation.
Assessment of patients' environmental exposure
Time frame: At baseline
Allergens will be analyzed in the dust collected during 2 weeks in the children's bedroom and pollutants will be identified in the children's hair. Researchers want to describe factors of environmental exposure which are linked to a poor response to treatment, immune imbalance and risk of asthma exacerbations.
Monitoring physical activity using accelerometer bracelet
Time frame: At baseline and at the end of the intervention (12 weeks)
Physical activity will be monitored for one week, at baseline and at the end of the intervention, using an accelerometer bracelet. Researchers expect to follow the evolution of physical activity, as better asthma control will most likely translate into more physical activity.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (2)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
2 locations
CHC Mont LégiaLiège, BelgiumRecruiting
Luxembourg Research Clinic (LRC)Luxembourg, LuxembourgRecruiting
Study team and timeline
- Lead sponsor
- Luxembourg Institute of Health
- Study start
- Jan 2, 2026 Actual
- Primary completion
- 2027-08 Estimated
- Study completion
- 2027-08 Estimated
- First posted
- Mar 30, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Advancing Diagnosis and Treatment of Pediatric Asthma by Deep Immunophenotyping and Evaluation of Two Spacer Devices for Inhaled Corticosteroid Administration
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026