Improving diagnosis and treatment for children with asthma
Official title: Advancing Diagnosis and Treatment of Pediatric Asthma by Deep Immunophenotyping and Evaluation of Two Spacer Devices for Inhaled Corticosteroid Administration
Run by Luxembourg Institute of Health · NCT07500246 · Data updated 2026-11-12
This project will test whether a digital inhaler and spacer system helps children aged 5–16 with partly controlled or uncontrolled asthma take their inhaled corticosteroids more reliably, improve asthma control, and help identify noninvasive biomarkers and environmental triggers that affect treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 16 Years |
| Sex | All |
| Enrollment | 208 (estimated) |
| Sponsor | Luxembourg Institute of Health Government |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Liège and 1 other locations) |
| Status | Recruiting |
| Started | January 2, 2026 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07500246 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 5–16 with a physician diagnosis of asthma requiring controller therapy with inhaled corticosteroids (with or without LABA) via MDI and who have partly controlled or uncontrolled asthma, with consent from a legally authorized representative and assent when applicable, are ideal candidates.
✕Probably not a fit
Children with severe asthma (per GINA), recent systemic corticosteroid treatment for exacerbation, active respiratory infection, other chronic lung diseases, significant immunodeficiency or immunosuppression, current immunotherapy (where excluded), or those outside the 5–16 age range are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children aged 5 to 16 with partly controlled or uncontrolled asthma who use MDI-based inhaled corticosteroids will use a digital inhaler and spacer system (Whizz spacer system, AeroChamber Plus® Flow-Vu®) while researchers monitor inhalation technique and medication adherence. The study will collect noninvasive biomarker samples and track environmental exposures to explore links with diagnosis and treatment response. Outcomes will include changes in adherence, asthma control, and candidate biomarkers that correlate with response, plus analyses of how environmental factors modify outcomes. Findings aim to combine device-based adherence support with biomarker and exposure data to guide more personalized asthma care.
Why it matters
Potential benefit: If successful, this approach could help children use inhalers more effectively, reduce symptoms, and support more personalized treatment decisions using biomarkers and exposure data.
How similar studies have gone: Prior studies have shown that digital inhaler feedback and spacers can improve inhalation technique and adherence, while biomarker-driven and environmental approaches to personalize asthma care are promising but still emerging.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
CHC Mont Légia
Liège, Belgium Recruiting -
Luxembourg Research Clinic (LRC)
Luxembourg, Luxembourg Recruiting
Study contacts
- Principal investigator: Christiane Hilger, PhD — Luxembourg Institute of Health
- Study coordinator: Christiane Hilger, PhD
- Email: christiane.hilger@lih.lu
- Phone: +352 26970258
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.