NCT07500246Recruiting
Advancing Diagnosis and Treatment of Pediatric Asthma
Advancing Diagnosis and Treatment of Pediatric Asthma by Deep Immunophenotyping and Evaluation of Two Spacer Devices for Inhaled Corticosteroid Administration
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 208 (estimated)
- First submitted
- 24 Mar 2026
- Start date
- 2 Jan 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Luxembourg Institute of Health
- Diseases
- Asthma
- NCT number
- NCT07500246
What you commit to
- Study type: Interventional
- Planned participants: 208
- From 2 Jan 2026 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with severe asthma exacerbation treated with systemic corticosteroids within the last 2 weeks or patients with active respiratory tract infection
- In receipt of immunotherapy (only for participants in Luxembourg donating samples for biomarker research)
Other illness
- Diagnosis of underlying chronic lung disease other than asthma (e.g., BPCO/cystic fibrosis etc.)
- Severe underlying disorders ((severe congenital heart disease, oncologic patients) (non-exhaustive list, left to the evaluation of the PI))
- Patients with neurological diseases / impaired cognitive disorder
Other
- Severe asthma based on GINA definitions
- Immune deficiency or under immunosuppressive treatments
- Siblings of patients already included in the study
Who the study is looking for
- 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)
Age in the registry: 5 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Luxembourg Research Clinic (LRC) Coordinator of this site? Confirm its status | Luxembourg | Luxembourg | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.