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| ID | Type | Description | Link |
|---|---|---|---|
| PPPHealthTech2021/16734157 | Other Grant/Funding Number | Fonds National de la Recherche (FNR) |
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| Name | Class |
|---|---|
| Luxembourg National Research Fund | OTHER |
| Centre Hospitalier du Luxembourg | OTHER |
| Meracle Health (Luxembourg) S.à.r.l | INDUSTRY |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled corticosteroid administration in asthmatic children using AeroChamber Plus® Flow-Vu® | Active Comparator | 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. |
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| Inhaled corticosteroid administration in asthmatic children using the Whizz spacer. | Experimental | 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. |
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| Non-asthmatic children | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whizz spacer system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of inhaled corticosteroid therapy adherence and comparison between the two spacers | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of asthma control | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christiane Hilger, PhD | Contact | +352 26970258 | christiane.hilger@lih.lu | |
| Ali Znati | Contact | +352 26970-811 | ALi.Znati@lih.lu |
| Name | Affiliation | Role |
|---|---|---|
| Christiane Hilger, PhD | Luxembourg Institute of Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luxembourg Research Clinic (LRC) | Recruiting | Luxembourg | Luxembourg |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| AeroChamber Plus® Flow-Vu® | Device | 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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| Quantification of inflammatory markers and deep immunophenotyping of circulating immune cells to identify non-invasive biomarkers and immune signatures |
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) |
| Assessment of patients' environmental exposure | 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 |
| Monitoring physical activity using accelerometer bracelet | 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) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |