Care4Asthma

Advancing diagnosis and treatment of pediatric asthma by deep immunophenotyping and evaluation of two spacer devices for inhaled corticosteroid administration

Asthma is one of the most common chronic diseases in children, and successful treatment depends on using inhaled medication correctly and consistently. This study aims to investigate whether a new digital inhaler spacer, called the Whizz spacer, can help children with asthma improve their inhaler technique, increase adherence to treatment, and achieve better asthma control. The study will compare the Whizz spacer with a standard spacer device in children aged 5 to 16 years with partly controlled or uncontrolled asthma. Researchers will also analyse biological samples and environmental factors, such as allergen and pollution exposure, to identify biomarkers that may help predict treatment response and support more personalised asthma care. The findings could contribute to simpler, more effective asthma management strategies for children and their families.

About the study

Recruiting
Patients, Healthy Volunteers 5–16 years
Immunity and Infection, Pediatrics & Rare diseases

Locations

Centre Hospitalier de Luxembourg – CHL KannerKlinik CHL KannerKlinik
4, rue Ernest Barblé
L-1210 Luxembourg

Want to learn more?

Who can participate?

Eligible participants

You may be eligible to participate as a patient if you:

  • Are between 5 and 16 years of age.
  • Have been diagnosed with asthma requiring regular treatment with an inhaled corticosteroid (with or without a long-acting bronchodilator) delivered by a metered-dose inhaler.
  • Have partly controlled or uncontrolled asthma based on GINA criteria and definition.
  • Have a parent or legal guardian who is willing to provide written informed consent (and, for children agend ≥10 years, the child’s assent).

Your child may be eligible to participate as a non-asthmatic control if they:

  • Are between 5 and 16 years of age.
  • Have not been diagnosed with asthma.
  • Have a blood test foreseen in their medical routine follow up for a non-respiratory disease (e.g. CAKUT, congenital lung malformations, drug allergies, endocrine disorders).
  • Have a parent or legal guardian who is willing to provide written informed consent (and, where applicable, the child’s assent).

Exclusion criteria

Your child may not be eligible to participate as a patient if they:

  • Do not meet the age requirement.
  • Have had a severe asthma attack requiring treatment with oral or injectable corticosteroids within the past 2 weeks or currently have a respiratory infection.
  • Have another chronic lung disease, such as BPCO, cystic fibrosis, or similar.
  • Have severe asthma.
  • Have a serious underlying medical condition or a weakened immune system.
  • Are receiving immunotherapy (for participants in Luxembourg taking part in the biomarker research component of the study).
  • Have a neurological condition or cognitive impairment that would make participation difficult.
  • Have a brother or sister who is already participating in the study.

Your child may not be eligible to participate as a non-asthmatic control if they:

  • Do not meet the age requirement.
  • Have a confirmed diagnosis of asthma or respiratory or food allergy.
  • Have a respiratory tract infection.
  • Have another chronic lung disease, such as cystic fibrosis.
  • Have a serious underlying medical condition or a weakened immune system.
  • Are receiving immunotherapy (for participants in Luxembourg taking part in the biomarker research component of the study) or anti-epileptic treatment.
  • Patients with underlying pro-inflammatory disorder (e.g., obesity, chronic inflammatory bowel disease)
  • Have a neurological condition or cognitive impairment that would make participation difficult.
  • Have a brother or sister who is already participating in the study.

Not sure about eligibility?

The study team will review each case individually to determine eligibility. If you are unsure whether you are eligible, do not hesitate to contact us.

What will participants do?

If you decide for your child to participate as a patient, you, respectively your child will be asked to:

01.

Use the assigned inhaler spacer

You will use either the Whizz digital spacer or the standard AeroChamber Plus® Flow-Vu® with your child’s prescribed asthma medication for 12 weeks.

02.

Complete a daily study diary

You will record your child’s asthma treatment and inhaler use throughout the study.

03.

Attend study visits with your child

These will take place at the start of the study, after 6 weeks, and after 12 weeks. Your child’s asthma control and quality of life will be assessed through questionnaires and clinical evaluations.

04.

Have your child undergo breathing tests

Spirometry and a fractional exhaled nitric oxide (FeNO) measurement will be performed at the beginning and end of the study to assess lung function and airway inflammation.

05.

Provide biological samples

These will be collected at the beginning and end of the study to help researchers identify biomarkers associated with asthma and treatment response.

06.

Provide a dust sample

This will be collected from your child’s bedroom at the start of the study to investigate how exposure to allergens may influence asthma symptoms.

07.

Provide a small hair sample

This will be collected at the start of the study to investigate exposure to environmental pollutants.

08.

Have your child wear an activity bracelet (optional)

This will be worn for 7 days at the beginning and again at the end of the study to monitor physical activity.

If you decide for your child to participate as a non-asthmatic control, you and your child will be asked to attend a single study visit during which they will be asked to:

01.

Fill out a questionnaire.

02.

Provide biological samples

These will help researchers to identify biomarkers associated with asthma and treatment response.

03.

Have your child undergo breathing test

A fractional exhaled nitric oxide (FeNO) measurement will be performed to assess lung function.

04.

Provide a small hair sample

This will be collected at the start of the study to investigate exposure to environmental pollutants.

05.

Provide a dust sample

This will be collected from your child’s bedroom at the start of the study to investigate how exposure to allergens may influence asthma symptoms.

06.

Have your child wear an activity bracelet (optional)

This will be worn for 7 days at the beginning and again at the end of the study to monitor physical activity.

Contact & location

Centre Hospitalier de Luxembourg – CHL KannerKlinik

Centre Hospitalier de Luxembourg – CHL KannerKlinik

CHL KannerKlinik
4, rue Ernest Barblé
L-1210 Luxembourg

Principal Investigator

Principal investigator

Dr Christiane Hilger

Group Leader, Molecular & Translational Allergology

Luxembourg Institute of Health (LIH)

Principal investigator

Patrick Feiereisen

Physiotherapist

Principal investigator

Dr Anna-Maria Charatsi

Paediatric pulmonologist

Centre Hospitalier de Luxembourg (CHL)

Study team

Dr Meriem Mastouri

Dr Meriem Mastouri

Paeditric pulmonologist

Centre Hospitalier de Luxembourg (CHL)
Dr Michael DELTENRE

Dr Michael DELTENRE

Paeditric pulmonologist

Centre Hospitalier de Luxembourg (CHL)

Participating institutions

Care4Asthma is an international study involving partners from Belgium (Clinique CHC Montlégia, Liège), Germany (Charité Berlin) and Luxembourg. Partners in Luxembourg include:

Funded by

Fonds National de la Recherche (FNR)

The Ministry of Economy

MERACLE Health

Luxinnovation

Want to learn more about the study?

Visit the Luxembourg Institute of Health website for full study details, scientific publications and research background.

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