Advancing Diagnosis and Treatment of Pediatric Asthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-16
SponsorLuxembourg Institute of Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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))
Trial design
Design model
Parallel
Treatments tested in this trial
Whizz spacer system
DeviceWhizz 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.
AeroChamber Plus® Flow-Vu®
DeviceAeroChamber Plus® Flow-Vu® is a standard valved holding chamber used to administer aerosolized medication from the metered dose inhaler to the patient.
Treatment groups
208 Participants
are divided into 3 treatment groupsGroup A: Inhaled corticosteroid administration in asthmatic children using AeroChamber Plus® Flow-Vu®Active comparator 1 intervention
Group B: Inhaled corticosteroid administration in asthmatic children using the Whizz spacer.Experimental treatment 1 intervention
Group C: Non-asthmatic childrenNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrolment to the end of the intervention at 12 weeksSecondary outcomes
1
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.
Time frame
At baseline and at the end of the intervention (12 weeks)2
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.
Time frame
At baseline and at the end of the intervention (12 weeks)3
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.
Time frame
At baseline4
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.
Time frame
At baseline and at the end of the intervention (12 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Luxembourg Institute of Health
Lead sponsor
Luxembourg National Research Fund
Collaborator
Centre Hospitalier du Luxembourg
Collaborator
Meracle Health (Luxembourg) S.à.r.l
Collaborator
Source ClinicalTrials.gov