Progressi nella Diagnosi e nel Trattamento dell'Asma Pediatrica (Care4Asthma)
Progressi nella Diagnosi e nel Trattamento dell'Asma Pediatrica mediante Immunofenotipizzazione Profonda e Valutazione di Due Dispositivi Distanziatori per la Somministrazione di Corticosteroidi Inalatori
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Christiane Hilger, PhD
- Numero di telefono: +352 26970258
- Email: christiane.hilger@lih.lu
Backup dei contatti dello studio
- Nome: Ali Znati
- Numero di telefono: +352 26970-811
- Email: ALi.Znati@lih.lu
Luoghi di studio
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Liège, Belgio, 4000
- Reclutamento
- CHC Mont Légia
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Contatto:
- Matthieu Thimmesch, M.D.
- Numero di telefono: +32 04 355 50 20
- Email: matthieu.thimmesch@chc.be
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Luxembourg, Lussemburgo
- Reclutamento
- Luxembourg Research Clinic (LRC)
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Investigatore principale:
- Anna-Maria Charatsi, MD
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Contatto:
- Ali Znati
- Numero di telefono: +352 26970-811
- Email: ALi.Znati@lih.lu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Inhaled corticosteroid administration in asthmatic children using 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. |
AeroChamber Plus® Flow-Vu® is a standard valved holding chamber used to administer aerosolized medication from the metered dose inhaler to the patient. |
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Sperimentale: Inhaled corticosteroid administration in asthmatic children using the Whizz spacer.
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. |
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. |
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Nessun intervento: Non-asthmatic children
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Measurement of inhaled corticosteroid therapy adherence and comparison between the two spacers
Lasso di tempo: From enrolment to the end of the intervention at 12 weeks
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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. |
From enrolment to the end of the intervention at 12 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Assessment of asthma control
Lasso di tempo: At baseline and at the end of the intervention (12 weeks)
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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. |
At baseline and at the end of the intervention (12 weeks)
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Quantification of inflammatory markers and deep immunophenotyping of circulating immune cells to identify non-invasive biomarkers and immune signatures
Lasso di tempo: At baseline and at the end of the intervention (12 weeks)
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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. |
At baseline and at the end of the intervention (12 weeks)
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Assessment of patients' environmental exposure
Lasso di tempo: At baseline
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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. |
At baseline
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Monitoring physical activity using accelerometer bracelet
Lasso di tempo: At baseline and at the end of the intervention (12 weeks)
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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. |
At baseline and at the end of the intervention (12 weeks)
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Christiane Hilger, PhD, Luxembourg Institute of Health
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Completamento dello studio (Stimato)
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Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
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Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CNER N°202506/05
- PPPHealthTech2021/16734157 (Altro numero di sovvenzione/finanziamento: Fonds National de la Recherche (FNR))
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