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Advancing Diagnosis and Treatment of Pediatric Asthma

RecruitingNAAges 5 Years - 16 YearsAllLuxembourg Institute of Health
NCT07500246 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 env

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📋 Eligibility rules (as published)
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
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What it tests

  • Whizz spacer system
  • AeroChamber Plus® Flow-Vu®
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Where

1 site
Luxembourg Research Clinic (LRC)
Luxembourg, Luxembourg
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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