Advancing Diagnosis and Treatment of Pediatric Asthma

NCT07500246 | Recruiting

• 2 other identifiers: CNER N°202506/05PPPHealthTech2021/16734157
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma Childhood; Asthma; Inhalation Spacers

Keywords

Asthma; Child; Immunophenotyping; Environmental exposure; Inhalation spacers; Allergy and asthma

Outcome Measures

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.

  From enrolment to the end of the intervention at 12 weeks

Secondary Outcomes (4)

• Assessment of asthma control

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

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

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

• Assessment of patients' environmental exposure

  At baseline

• Monitoring physical activity using accelerometer bracelet

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

Study Arms (3)

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.

Device: AeroChamber Plus® Flow-Vu®

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.

Device: Whizz spacer system

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.

Interventions

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.

Inhaled corticosteroid administration in asthmatic children using the Whizz spacer.

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.

Inhaled corticosteroid administration in asthmatic children using AeroChamber Plus® Flow-Vu®

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• Luxembourg National Research Fund (FNR): collaborator
• Centre Hospitalier du Luxembourg: collaborator
• Meracle Health (Luxembourg) S.à.r.l: collaborator

Study Sites (1)

Luxembourg Research Clinic (LRC)

Luxembourg, Luxembourg

RECRUITING

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Christiane Hilger, PhD

  Luxembourg Institute of Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christiane Hilger, PhD

CONTACT

+352 26970258; christiane.hilger@lih.lu

Ali Znati

CONTACT

+352 26970-811; ALi.Znati@lih.lu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-02

Locations

LU (1)