Asthma ChildhoodCare4AsthmaNCT07500246
Advancing Diagnosis and Treatment of Pediatric Asthma
A study testing Whizz spacer system and AeroChamber Plus® Flow-Vu® in people with Asthma Childhood and Asthma, run by Luxembourg Institute of Health at 1 site in Luxembourg.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Asthma Childhood, Asthma, Inhalation Spacers
- What is being tested?
- Whizz spacer system and AeroChamber Plus® Flow-Vu®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteLuxembourg
- Study dates
- 2 Jan 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Luxembourg1 site, 1 recruiting
- Recruiting
Luxembourg Research Clinic (LRC)
Luxembourg
Ali Znati, +352 26970-811, ALi.Znati@lih.lu
Anna-Maria Charatsi, MD
About this study
Official title: Advancing Diagnosis and Treatment of Pediatric Asthma by Deep Immunophenotyping and Evaluation of Two Spacer Devices for Inhaled Corticosteroid Administration
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?
Read more
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
- Being tested
- Whizz spacer system, AeroChamber Plus® Flow-Vu®
- Keywords
- Asthma, Child, Immunophenotyping, Environmental exposure, Inhalation spacers, Allergy and asthma
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whizz spacer systemDevice
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 group | Role | What they receive |
|---|---|---|
| Inhaled corticosteroid administration in asthmatic children using AeroChamber Plus® Flow-Vu® | Active comparator | 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. Receives: Device: AeroChamber Plus® Flow-Vu® |
| Inhaled corticosteroid administration in asthmatic children using the Whizz spacer. | Experimental | 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. Receives: Device: Whizz spacer system |
| Non-asthmatic children | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of inhaled corticosteroid therapy adherence and comparison between the two spacers
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.
Measured: From enrolment to the end of the intervention at 12 weeks
Secondary outcomes (4)
Assessment of asthma control
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.
Measured: At baseline and at the end of the intervention (12 weeks)
Quantification of inflammatory markers and deep immunophenotyping of circulating immune cells to identify non-invasive biomarkers and immune signatures
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.
Measured: At baseline and at the end of the intervention (12 weeks)
Assessment of patients' environmental exposure
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.
Measured: At baseline
Monitoring physical activity using accelerometer bracelet
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.
Measured: At baseline and at the end of the intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start2 Jan 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Collaborators
- Luxembourg National Research Fund, Centre Hospitalier du Luxembourg, Meracle Health (Luxembourg) S.à.r.l
- Responsible party
- Sponsor
- Investigators
- Christiane Hilger, PhD, Principal investigator, Luxembourg Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500246
- Sponsor's protocol ID
- CNER N°202506/05
- Other IDs
- PPPHealthTech2021/16734157
- Acronym
- Care4Asthma
- Status last verified
- Feb 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Diagnosis and Treatment of Pediatric Asthma by Deep Immunophenotyping and Evaluation of Two Spacer Devices for Inhaled Corticosteroid Administration
- ClinicalTrials.gov ID
- NCT07500246
- Acronym / sponsor ID
- Care4Asthma / CNER N°202506/05
- Conditions
- Asthma Childhood, Asthma, Inhalation Spacers
- Keywords
- Asthma, Child, Immunophenotyping, Environmental exposure, Inhalation spacers, Allergy and asthma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Collaborators
- Luxembourg National Research Fund, Centre Hospitalier du Luxembourg, Meracle Health (Luxembourg) S.à.r.l
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inhaled corticosteroid administration in asthmatic children using AeroChamber Plus® Flow-Vu® | Active comparator | Device: 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. |
| Inhaled corticosteroid administration in asthmatic children using the Whizz spacer. | Experimental | Device: Whizz spacer systemAsthmatic 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. |
| Non-asthmatic children | No intervention | –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. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whizz spacer systemWhizz 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 | Inhaled corticosteroid administration in asthmatic children using the Whizz spacer. |
| 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. | Device | Inhaled corticosteroid administration in asthmatic children using AeroChamber Plus® Flow-Vu® |
Primary outcome
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.
4 secondary outcomes
Assessment of asthma control
Time frame: At baseline and at the end of the intervention (12 weeks)
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)
Assessment of patients' environmental exposure
Time frame: At baseline
Monitoring physical activity using accelerometer bracelet
Time frame: At baseline and at the end of the intervention (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christiane Hilger, PhD principal investigator
Luxembourg Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whizz spacer system and AeroChamber Plus® Flow-Vu® in people with Asthma Childhood and Asthma, run by Luxembourg Institute of Health at 1 site in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christiane Hilger, PhD (+352 26970258, christiane.hilger@lih.lu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.