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소아 천식 진단 및 치료의 발전 (Care4Asthma)

2026년 11월 11일 업데이트: Luxembourg Institute of Health

심층 면역표현형 분석 및 흡입 코르티코스테로이드 투여용 두 가지 스페이서 장치 평가를 통한 소아 천진 진단 및 치료의 발전

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

208

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 룩셈부르크
      • Luxembourg, 룩셈부르크
        • 모병
        • Luxembourg Research Clinic (LRC)
        • 수석 연구원:
          • Anna-Maria Charatsi, MD
        • 연락하다:
  • 벨기에
      • Liège, 벨기에, 4000
        • 모병
        • CHC Mont Légia
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

5년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Inhaled corticosteroid administration in asthmatic children using AeroChamber Plus® Flow-Vu®

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.
장치: 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.
실험적: Inhaled corticosteroid administration in asthmatic children using the Whizz spacer.

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.
장치: 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.
간섭 없음: Non-asthmatic children

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Measurement of inhaled corticosteroid therapy adherence and comparison between the two spacers
기간: 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.
From enrolment to the end of the intervention at 12 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Assessment of asthma control
기간: 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.
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
기간: 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.
At baseline and at the end of the intervention (12 weeks)
Assessment of patients' environmental exposure
기간: 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.
At baseline
Monitoring physical activity using accelerometer bracelet
기간: 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.
At baseline and at the end of the intervention (12 weeks)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Luxembourg Institute of Health

협력자

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

수사관

  • 수석 연구원: Christiane Hilger, PhD, Luxembourg Institute of Health

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 1월 2일

기본 완료 (추정된)

2027년 8월 1일

연구 완료 (추정된)

2027년 8월 1일

연구 등록 날짜

최초 제출

2026년 3월 24일

QC 기준을 충족하는 최초 제출

2026년 3월 24일

처음 게시됨 (실제)

2026년 3월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 11일

마지막으로 확인됨

2026년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CNER N°202506/05
  • PPPHealthTech2021/16734157 (기타 보조금/기금 번호: Fonds National de la Recherche (FNR))

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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