NCT07500246 Advancing Diagnosis and Treatment of Pediatric Asthma
| NCT ID | NCT07500246 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Luxembourg Institute of Health |
| Condition | Asthma Childhood |
| Study Type | INTERVENTIONAL |
| Enrollment | 208 participants |
| Start Date | 2026-01-02 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 208 participants in total. It began in 2026-01-02 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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
Contact & Investigator
Christiane Hilger, PhD
PRINCIPAL INVESTIGATOR
Luxembourg Institute of Health
Frequently Asked Questions
Who can join the NCT07500246 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 16 Years, studying Asthma Childhood. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07500246 currently recruiting?
Yes, NCT07500246 is actively recruiting participants. Contact the research team at christiane.hilger@lih.lu for enrollment information.
Where is the NCT07500246 trial being conducted?
This trial is being conducted at Luxembourg, Luxembourg.
Who is sponsoring the NCT07500246 clinical trial?
NCT07500246 is sponsored by Luxembourg Institute of Health. The principal investigator is Christiane Hilger, PhD at Luxembourg Institute of Health. The trial plans to enroll 208 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.