Advancing Diagnosis and Treatment of Pediatric Asthma

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Whizz spacer system
  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.
• Устройство AeroChamber Plus® Flow-Vu®
  AeroChamber Plus® Flow-Vu® is a standard valved holding chamber used to administer aerosolized medication from the metered dose inhaler to the patient.

Первичные конечные точки

• Measurement of inhaled corticosteroid therapy adherence and comparison between the two spacers [Срок оценки: From enrolment to the end of the intervention at 12 weeks]

Вторичные конечные точки (4)

• Assessment of asthma control [Срок оценки: 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 [Срок оценки: At baseline and at the end of the intervention (12 weeks)]
• Assessment of patients' environmental exposure [Срок оценки: At baseline]
• Monitoring physical activity using accelerometer bracelet [Срок оценки: At baseline and at the end of the intervention (12 weeks)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Luxembourg · 1 центр

• Luxembourg Research Clinic (LRC) — Luxembourg

Идентификаторы

NCT: NCT07500246 · CNER N°202506/05 · PPPHealthTech2021/16734157

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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