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NCT Number: NCT07500246

Advancing Diagnosis and Treatment of Pediatric Asthma

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.

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Key information

Conditions

Asthma Childhood Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inhalation Spacers Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luxembourg Research Clinic (LRC)

Luxembourg

Location status: Recruiting

Location contact

Ali Znati

CONTACT

[email protected]

+352 26970-811

Anna-Maria Charatsi, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Measurement of inhaled corticosteroid therapy adherence and comparison between the two spacers

    Time frame: From enrolment to the end of the intervention at 12 weeks

    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.

Secondary outcomes

  1. Assessment of asthma control

    Time frame: At baseline and at the end of the intervention (12 weeks)

    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.

  2. Quantification of inflammatory markers and deep immunophenotyping of circulating immune cells to identify non-invasive biomarkers and immune signatures

    Time frame: At baseline and at the end of the intervention (12 weeks)

    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.

  3. Assessment of patients' environmental exposure

    Time frame: At baseline

    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.

  4. Monitoring physical activity using accelerometer bracelet

    Time frame: At baseline and at the end of the intervention (12 weeks)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Znati

CONTACT

[email protected]

+352 26970-811

Christiane Hilger, PhD

CONTACT

[email protected]

+352 26970258

Sponsors and collaborators

Lead sponsor

Luxembourg Institute of Health

Other Gov

Collaborators

  • Centre Hospitalier du Luxembourg
  • Luxembourg National Research Fund
  • Meracle Health (Luxembourg) S.à.r.l

Registry information

Official study title

Advancing Diagnosis and Treatment of Pediatric Asthma by Deep Immunophenotyping and Evaluation of Two Spacer Devices for Inhaled Corticosteroid Administration

Acronym: Care4Asthma

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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